MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'drug regulations'. Sat, 03 Sep 2011 02:54:48 +0100 http://www.medworm.com/index.php?rid=4326902&cid=t_221059_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fthe-energy-drink%2F2011.01.09 By Scott Gavura, BScPhm, MBA, RPh for Science-Based Medicine My stimulant of choice is coffee. I started drinking it in first-year university, and never looked back. A tiny four-cup coffee maker became my reliable companion right through graduate school. But since I stopped needing to drink a pot at a time, an entirely new category of products has appeared — the energy drink. Targeting students, athletes, and others seeking a mental or physical boost, energy drinks are now an enormous industry: From the first U.S. product sale in 1997, the market size was $4.8 billion by 2008, and continues to grow. (1) My precious coffee effectively has a single therapeutic ingredient, caffeine. Its pharmacology is well documented, and the physiologic effects are understood. The safety data isn’... Better Health blogs http://www.medworm.com/rss/comments.php?id=4326902 Sun, 09 Jan 2011 17:00:48 +0100 4326902 http://www.medworm.com/index.php?rid=2090047&cid=t_221059_134_f&fid=35187&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FDiabetesDaily%2F%7E3%2F506332138%2Fpetition-the-fda-to-hear-our-complaints.php There is a very important petition circulating right now. Co-signed by many of the major voices in diabetes (including ours), it asks the Food and Drug Administration to lower the barriers on new diabetes treatments. Please take a moment to... (Source: Diabetes Daily) Diabetes Daily blogs http://www.medworm.com/rss/comments.php?id=2090047 Thu, 08 Jan 2009 16:03:57 +0100 2090047 http://www.medworm.com/index.php?rid=2510712&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmaGazette%2F%7E3%2F3Cq56JChK_0%2Ftopamax_gets_6_month_pediatric_exclusivity_extension.html The U.S. Food and Drug Administration has granted a six month pediatric exclusivity to Ortho-McNeil-Janssen Pharmaceuticals for its drug Topamax for use in patients aged 1 to 24 months with partial onset seizures.The extension does not give the drug FDA approval but instead allows the pharmaceutical 6 months to continue to investigate the use of Topamax on this specific segment of patients.Currently Topamax is approved for use with patients 10 years of age and older with partial onset seizures or generalized tonic-clonic seizures. It is also indicated in adults for the treatment of migraine headaches.Recent research may have found a link between the use of Topamax and birth defects and recently, along with other epilepsy drugs, narrowly escaped being required to have a black box warni... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=2510712 Fri, 25 Jul 2008 17:00:16 +0100 2510712 http://www.medworm.com/index.php?rid=1622216&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F335215369%2Ffda_changes_drug_application_process.html The U.S. Food and Drug Administration announced that it has revised its method of communicating that a drug cannot be approved as submitted to pharmaceutcial companies.Previously the FDA's Center for Drug Evaluation and Research (CDER) issued "approvable" or "non-approval" letters when a drug application was not approved. The new approval process will consist only of a "complete response" letter at the end of the review process to inform the drug company of the agency's decision."These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluati... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1622216 Mon, 14 Jul 2008 17:00:32 +0100 1622216 http://www.medworm.com/index.php?rid=1556385&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F323640511%2Fgsk_answers_fda_on_cervarix.html GlaxoSmithKline (NYSE:GSK) announced that it has submitted its response to the U.S. Food and Drug Administration to questions the agency had in response to GSK's drug application for Cervarix.Cervarix, a vaccine for the prevention of cervical cancer, one of the largest drug hopes in Glaxo's pipeline has already been approved in 67 countries but the FDA issued a "Complete Response" letter in December 2008 requiring the company answer questions."Study 008 is a key study that will be completing later this year, andwe expect the final results will strengthen the U.S. label forCERVARIX(R)," said Barbara Howe, M.D., Vice President and Director, NorthAmerican Vaccine Development, GlaxoSmithKline. "We continue to havepositive and productive disc... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1556385 Mon, 30 Jun 2008 19:00:46 +0100 1556385 http://www.medworm.com/index.php?rid=1543340&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319965579%2Ffda_approves_combo_vaccine_kinrix_for_kids.html The U.S. Food and Drug Administration has approved GlaxoSmithKline's combination booster vaccine, Kinrix.Kinrix protects children between 4 and 6 years old against diphtheria, pertussis, polio and tetanus and is approved for children who previously received GSK's Infanrix, which covers diptheria, tetanus and pertussis and who received Pediarix. Pediarix is a combination vaccine that covers DPT, hepatitis B and polio."Children 4 to 6 years-old can receive five or more vaccinations in a single visit, which can be stressful for parents and vaccinators," said William P. Hitchcock, M.D., Assistant Clinical Professor of Pediatrics, University of California, San Diego School of Medicine. "By reducing the number of shots given in one visit, combination vaccines like Kinrix m... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543340 Wed, 25 Jun 2008 19:00:43 +0100 1543340 http://www.medworm.com/index.php?rid=1543341&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319955555%2Ffda_delays_prasugrel_approval.html Eli Lilly & Co and Daiichi Sankyo announced the U.S. Food and Drug Administration had extended the period of review by three months for their anti-clotting drug, Prasugrel.Prasugrel received priority review status from the FDA in February based on studies that showed Prasugrel has better results than Plavix but carried a higher risk of bleeding in some patients."We remain confident in our prasugrel submission package," said Jennifer Stotka, vice president for global regulatory affairs at Lilly.Daiichi and Lilly confirmed plans to start a Phase III clinical trial this month that will compare the results of prasugrel against Plavix in patients with acute coronary syndromes. The trials will consisted of 10,000 patients at over 800 hospitals.The FDA is expected to act on the... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543341 Wed, 25 Jun 2008 18:00:38 +0100 1543341 http://www.medworm.com/index.php?rid=1543343&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319775023%2Fgardasil_gets_fda_non-approval_for_expanded_use.html Merck & Co. (NYSE:MRK) announced that the U.S. Food and Drug Administration did not approve the company's application to expand the use of Gardasil to include women between the ages of 27 and 45.Gardasil, a cervical cancer vaccine, was previously approved by the FDA in 2006 for women between the ages of 9 and 27 and the non-acceptance of the expanded use does not affect that approval. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543343 Wed, 25 Jun 2008 15:00:12 +0100 1543343 http://www.medworm.com/index.php?rid=1543344&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319116896%2Ffda_approves_cymbalta_for_fibr.html Eli Lilly & Co. (NYSE:LLY) announced that it has received U.S. Food and Drug Administration approval for Cymbalta for the management of fibromyalgia, a chronic pain disorder.Cymbalta (duloxetine HCl) is the first serotonin-norepinephrine reuptake inhibitor that has proven effective in the treatment of pain associated with fibromyalgia. The new approved indication becomes the fourth FDA approved use of the drug.  Cymbalta has been previously approved for management of diabetic peripheral neuropathic pain (DPNP), the treatment of major depressive disorder and generalized anxiety disorder. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543344 Tue, 24 Jun 2008 18:00:45 +0100 1543344 http://www.medworm.com/index.php?rid=1543346&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F319036633%2Favodart_fda_approved_for_symptomatic_enlarged_prostate.html The U.S. Food and Drug Administration has approved GlaxoSmithKline(NYSE:GSK) Avodart in combination with tamsulosin for the treatment of symptomatic enlarged prostate.Enlarged prostate is a disease that affects 50% of men over the age of 50 and 90% of men over the age of 80. The disease causes changes in urinary habits and over time the prostate can continue to enlarge and the bladder can loses its ability to empty itself. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1543346 Tue, 24 Jun 2008 15:00:19 +0100 1543346 http://www.medworm.com/index.php?rid=1497502&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F305317831%2Fhumira_remicade_and_enbrel_under_fda_review_for_cancer_link.html   The U.S. Food and Drug Administration announced that it is investigating whether a group of arthritis drugs increase the risk of pediatric cancer. The group of drugs include Abbott Laboratories' Humira, Schering-Plough's Remicade and Enbrel by Amgen and Wyeth.The FDA stated that it has received 30 reports of children and young adults developing cancer while taking the arthritis medications. The reports were received to the FDA's Adverse Event Reporting System over a 10 year period. Children with arthritis, and sometimes Crohn's disease, are prescribed these drugs to block a chemical that causes inflammation. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1497502 Thu, 05 Jun 2008 13:00:36 +0100 1497502 http://www.medworm.com/index.php?rid=1480736&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F301431509%2Fyesterday_i_brought_you_an.html Yesterday I brought you an article about a new experimental drug from GlaxoSmithKline called Promacta. Its purpose is to lower bleeding in patients with rare blood disorders but the U.S. Food and Drug Administration released a report stating that the agency had found that the drug did not, yes i repeat, NOT, significantly lower bleeding.The next step was to submit all data to a panel of outside advisors who would vote on whether they had found that the drug fell within acceptable parameters.Today it was announced, by the FDA, that the panel voted unanimously in favor of Promacta. It was noted, however, that long-term data has not been provided but that results from two six-week studies showed significant benefit. Long term benefit data is expected by year end. The FDA has until J... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1480736 Fri, 30 May 2008 17:00:40 +0100 1480736 http://www.medworm.com/index.php?rid=1478027&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F300764496%2Fwyeth_receieves_approvable_let.html Wyeth Pharmaceuticals announced that it has received and approvable letter from the U.S. Food and Drug Administration for its first-in-class antibiotic drug Tygacil. Tygacil (tigecycline) is indicated for the treatment of adult patients with community-acquired pneumonia (CAP).Prior to granting approval the the FDA has request that Wyeth submit additional analyses supporting the safety and efficacy of the drug. The FDA also required that benefit/risk analysis be submitted for any potential liver toxicity."We believe the data from our current clinical development program support TYGACIL as a potential therapeutic option for patients with CAP," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "Wyeth is committed to working with ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1478027 Thu, 29 May 2008 19:00:31 +0100 1478027 http://www.medworm.com/index.php?rid=1478029&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F300748888%2Fpromacta_fails_to_control_blee.html The U.S. Food and Drug Administration announced that it found that Promacta does not significantly lower bleeding in patients with rare blood disorders.FDA reviewers stated that upon review of company studies that Promacta, an experimental drug from GlaxoSmithKline, was not found to help control the severity and frequency of bleeding as purported by the company. Of the two studies submitted by GlaxoSmithKline, neither showed a significant difference between patients receiving Promacta and those that received a placebo.GlaxoSmithKline had applied for a New Drug Application for Promacta (eltrombopag olamine) with the FDA in December of 2007 and had released previous reports that the drug had decreased bleeding in previous trials.The drug was intended to treat idiopathic thrombocyto... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1478029 Thu, 29 May 2008 17:00:35 +0100 1478029 http://www.medworm.com/index.php?rid=1466099&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F296646640%2Fwyeth_gets_fda_approvable_letter_for_bazedoxifene.html Wyeth Pharmaceutucals announced that it has received an Approvable Letter from the U.S. Food and Drug Administration for bazedoxifene, a selective estrogen receptor modulator (SERM), for the prevention of postmenopausal osteoporosis. Gary Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals stated: "We will work closely with the FDA to address the items noted in the letter and are moving forward with plans to seek an additional indication for the treatment of postmenopausal osteoporosis for bazedoxifene later this year. We remain confident that bazedoxifene has the potential to become an important option for the millions of postmenopausal women who are at risk for developing an osteoporotic fracture."The approvable letter states that prior to th... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1466099 Fri, 23 May 2008 15:00:15 +0100 1466099 http://www.medworm.com/index.php?rid=1409765&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F280779831%2Famitiza_fda_approved_for_ibsc.html The U.S. Food and Drug Administration has confirmed that lubiprostone, brand name Amitiza, has been approved as the only prescription drug therapy FDA approved treatment for Irritable Bowel Syndrome with Constipation (IBS-C) in women over 18."For some people IBS can be quite disabling, making it difficult for them to fully participate in everyday activities," said Julie Beitz, M.D., director of the Office of Drug Evaluation III, Center for Drug Evaluation and Research, FDA. "This drug represents an important step in helping to provide medical relief from their symptoms."IBS symptoms include cramping, abdominal pain, bloating, constipation and diarrhea and the illness seems to affect 2x the number of woman as men.The safety and efficacy studies of Amitiza ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1409765 Tue, 29 Apr 2008 19:00:45 +0100 1409765 http://www.medworm.com/index.php?rid=1402141&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F278464653%2Fcimzia_approved_by_fda_to_trea.html The U.S Food and Drug Administration has approved Cimzia (certolizumab pegol) for the treatment of moderate to serve Crohn's disease in adults who have not responded to other therapies."Crohn's is a debilitating disease that disrupts the quality of life for its sufferers," said Julie Beitz, M.D., director of the Office of Drug Evaluation III for the FDA's Center for Drug Evaluation and Research. "This drug works to reduce the signs and symptoms of Crohn's, but it also carries risks that will require patients on it to be closely monitored by their physicians or other health care professionals."Cimzia is to be given, by injection, every two weeks for the first 3 injections and once the medication's benefit has been established patients are to receive t... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1402141 Sat, 26 Apr 2008 21:00:49 +0100 1402141 http://www.medworm.com/index.php?rid=1401383&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F278439764%2Frelistor_fda_approved_for_opio.html The U.S. Food and Drug Administration announced on Thursday that it has approved Relistor (methylnaltrexone bromide) for use with patients who are receiving opioids to treat pain in late-stage, advanced illnesses to help restore bowel function.According to the FDA news release opioids can "interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products." Relistor blocks opioids from entering the smooth muscles of the intestine and allows the blowels to function normally.“This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advan... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1401383 Sat, 26 Apr 2008 20:00:33 +0100 1401383 http://www.medworm.com/index.php?rid=1352103&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F264203408%2Frotarix_gets_fda_approval.html The U.S. Food and Drug Administration has approved Rotarix, the oral vaccine for the prevention of rotavirus, for children between the ages of 6 to 24 weeks.Rotavirus is an infection that causes gastroenteritis, vomiting and diarrhea, which causes approximately 55,000 to 70,000 cases of hospitalization and 20 to 60 deaths in the U.S. every year. The vaccine is a liquid which is given orally to children in a two-dose series protects against the G1, G3, G4 and G9 strains of rotavirus gastroenteritis.The FDA estimates that without the vaccine almost every child in the U.S. would be infected at least once by the age of 5."This vaccine provides another option to combat and reduce a potentially severe illness that affects so many children," said Jesse L. Goodman, M.D., M.P.H., dir... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1352103 Fri, 04 Apr 2008 20:00:02 +0100 1352103 http://www.medworm.com/index.php?rid=1327525&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F257942669%2Ftreanda_gets_fda_approval_for.html The U.S. Food and Drug Administration has approved Treanda (bebdanustine hydrocloride) for patients with the slow growing blood and bone marrow cancer chronic lymphocytic leukemia (CLL).The drug, marketed by Cephalon, is a chemotherapy drug that has shown to slow the progression of the disease will be available as an alternative treatment option as of April.A randomized study of 301 patients found that 59% of those taking Treanda had their cancer significantly reduced compared to 26% of those taking Leukeran (chlorombucil), a drug commonly used to treat CLL.Researchers believe that Treanda works by disrupting cell division and damaging DNA in tumor cells leading to cell death.Cephalon has also applied to the FDA for approval of Treanda for the treatment of non-Hodgkin lymphoma in pati... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1327525 Tue, 25 Mar 2008 20:00:53 +0100 1327525 http://www.medworm.com/index.php?rid=1286275&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F247575942%2Ffda_warns_on_unapproved_and_mi.html The U.S. Food and Drug Administration issued Warning Letters to six U.S companies for marketing unapproved and misbranded drug that are being sold over the internet claiming to prevent and treat sexually transmitted diseases.The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus and some claim to have "FDA Approval" or claim to be more effective that standard medication. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1286275 Fri, 07 Mar 2008 18:00:27 +0100 1286275 http://www.medworm.com/index.php?rid=1245115&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F238238499%2Fsanofiaventis_xyzal_tablets_ge.html sanofi-aventis (EPA:SAN) and UBC announced that the U.S. Food and Drug Administration has approved a New Drug Application (NDA) for Xyzal (levocetirizine dihydrochloride) 0.5 mg/ml oral solution.Xyzal is an oral antihistamine, available only by prescription, for the relief of symptoms associated with indoor and outdoor allergies and is also indicated for the treatment of chronic idiopathic urticaria.The tablet form of Xyzal received FDA approval in May, 2007 and both the tablet and oral formulations are now approved for use in adults and children over the age of 6."The oral solution of Xyzal provides a welcome alternative for those patients who have difficulty swallowing or who prefer liquid medication," said Michael S. Blaiss, MD, Clinical Professor of Paediatrics and Medic... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1245115 Wed, 20 Feb 2008 15:00:06 +0100 1245115 http://www.medworm.com/index.php?rid=1216524&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F231210557%2Fteva_gets_fda_approval_for_gen.html Teva Pharmaceuticals USA has received U.S. Food and Drug Administration approval to manufacture generic Fosamax.Alendronate sodium tablets are indicated for the treatment of osteoporosis, a condition that causes thinning and weakening of the bones.Approved dosages will be available in three once-daily dosages of 5 milligrams, 10 milligrams and 40 milligrams and the two once weekly dosages of 35 milligrams and 70 milligrams."The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process," said Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs. "These approvals will provide generic options for patients who take Fosamax for their osteoporosis."Generic manufacturers must show that a generic drug h... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1216524 Thu, 07 Feb 2008 20:00:35 +0100 1216524 http://www.medworm.com/index.php?rid=1212094&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F230434278%2Froches_xeloda_gets_ec_approval.html The European Commission has approved Roche's oral chemotherapy Xeloda for treatment of metastatic colorectal cancer in combination with any chemotherapy with or without Avastin.The approval of the new indication will allow more patients that have colorectal cancer that has spread to be able to take advantage of the treatment. Pivotal studies demonstrated that Xeloda tablets provided patients with a more flexible treatment that delivered the same survival rates as previously standard chemotherapy treatments. Other studies have shown Xeloda to be more effective than other standard therapies."Colorectal cancer is a devastating disease and treatment options for patients have been limited," said Professor Jim Cassidy, Cancer Research UK Professor of Oncology and Chair of Medical O... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1212094 Wed, 06 Feb 2008 17:00:44 +0100 1212094 http://www.medworm.com/index.php?rid=1207467&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F229807116%2Ffda_grants_priority_review_for_multiple_myeloma_drug_velcade.html Millennium Pharmaceuticals (NASDAQ:MLNM) announced that its multiple myeloma (MM) drug Velcade has been granted priority review by the U.S. Food and Drug Administration. Millenium is looking for a new indication to allow newly diagnosed MM patients to be treated with Velcade.Data submitted to the FDA for the supplemental New Drug Application (sNDA) included data from the phase III VISTA study which was a large, international clinical trial that compared Velcade to traditional treatment. Velcade is already the market leader for MM patients that have attempted at least one prior therapy."Priority review designation puts us on track for a potential label expansion decision by June 20," said Nancy Simonian, M.D., chief medical officer, Millennium. "The rapid action by the F... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1207467 Tue, 05 Feb 2008 18:00:07 +0100 1207467 http://www.medworm.com/index.php?rid=1207469&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F229712151%2Fasmanex_twisthaler_from_scheri.html Schering-Plough Corp (NYSE:SGP) announced that the U.S. Food and Drug Administration has approved its once-a-day asthma corticosteroid inhaler for children. The inhaled steroid for the prevention of asthma attacks can be used with children as young as 4.Asmanex Twisthaler received FDA approval two years ago as a maintenance treatment to prevent flare-ups in adults and children over the age of 12. The dosage for children under 12 is roughly half the adult dosage of 220 micrograms. While other asthma product exisit for young children all must be taken more often throughout the day.The unique aspect of the Twisthaler is that it does not have a propellant like other inhalers. It is activated as the patients inserts the inhaler into their mouth and inhales. A counter on the product keeps track ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1207469 Tue, 05 Feb 2008 16:00:20 +0100 1207469 http://www.medworm.com/index.php?rid=1185818&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F225444014%2Fastellas_mycamine_gets_additional_indication_fda_approval.html The U.S. Food and Drug Administration has approved Astella Pharma Inc's Supplemental New Drug Application (sNDA) for use of Mycamine in the treatment of patients with Candidemia, Acute Disseminate Candidiasis, Candida Peritonitis and Abscesses.Mycamine, an injectable treatment, is part of the echinocandins class of antifungal agents and was approved for use in 2005 for patients with esophageal candidiasis. It is the only approved treatment for the prophylaxis of Candida infections in patients that are undergoing hematopoietic stem cell transplantation."The FDA's approval of this sNDA further confirms the safety and efficacy profile of MYCAMINE and its importance in the treatment of candidemia and other Candida infections," said Yoshihiko Hatanaka, President and Chief Exec... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1185818 Tue, 29 Jan 2008 17:00:42 +0100 1185818 http://www.medworm.com/index.php?rid=1169789&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F221177993%2Ffda_approves_new_version_of_te.html Tekturna, a high blood pressure medication that was previously approved last March by the U.S. Food and Drug Administration, has received new approval for its combined form of hypertension medication and diuretic.Hydrochlorothiazide, a compound that inhibits the kidneys ability to retain water, has been added to Tekturna's high blood pressure medication aliskiren. Aliskiren is a direct renin inhibitor (DRI) which targets renin an enzyme responsible for hypertension. Tekturna HCT is available in tablet form and is intended for use by patients that have been unsuccessful in controlling their high blood pressure with a single drug. Novartis expects the medication to be available in early February.Side effects of this new hypertension/water pill can include dizziness, c... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1169789 Tue, 22 Jan 2008 17:00:32 +0100 1169789 http://www.medworm.com/index.php?rid=1169790&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F221163390%2Fabbottt_gets_fda_approval_for_humira_for_plaque_psoriasis.html Abbott Laboratories (NYSE:ABT) announced that it has received the fifth indication for its drug Humira. The new indication gives the company U.S. Food and Drug Administration approval to market Humira as a treatment for moderate to severe psoriasis."The approval of HUMIRA for psoriasis is welcome news for people living with this challenging, lifelong disease," said Pam Field, acting president and CEO, National Psoriasis Foundation. "We are pleased to let people with plaque psoriasis know they now have a new treatment option available to them."Psoriasis is an autoimmune disease that is characterized by skin lesions that can be painful and itchy. It is estimated that 125 million people worldwide suffer from psoriasis which can lead to poor self-image and isolation to... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1169790 Tue, 22 Jan 2008 16:00:17 +0100 1169790 http://www.medworm.com/index.php?rid=1166418&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F220604911%2Fwelchol_receives_fda_approval.html Daiichi Sankyo Inc. announced that it has received U.S. Food and Drug Administration approval for its drug Welchol that improves glycemic control when combined with metformin, sulfonylureas or insulin in patients with Type 2 diabetes.Welchol becomes the only FDA approved medication that reduces both glucose levels and low density lipoprotien cholesterol levels (LDL-C). The American Diabetes Association estimates that 40% of patients with Type 2 diabetes also have increased levels of LDL-C and Welchol affords the opportunity to treat both conditions with one medication."We are excited by the opportunity to help more patients with chronic conditions reach their recommended health goals," said Joseph P. Pieroni, President and CEO of Daiichi Sankyo, Inc. "This approval represent... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1166418 Mon, 21 Jan 2008 20:00:26 +0100 1166418 http://www.medworm.com/index.php?rid=1166420&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F220481777%2Fbirth_control_patch_gets_updat.html The Ortho Evra Contraceptive Transdermal (skin) Patch now has additional changes to its label. The U.S. Food and Drug Administration approved the changes as a result of a new epidemiology study that stated the users of the patch were at a higher risk for developing serious blood clots, known as venous thromboembolism (VTE) than women using birth control pills."For women that choose to use contraceptives, it is important that they thoroughly discuss with their health care providers the risks and benefits involved," said Janet Woodcock, M.D., the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the Center for Drug Evaluation and Research. "This is an example of FDA working in tandem with the drug manufacturer to k... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1166420 Mon, 21 Jan 2008 16:00:52 +0100 1166420 http://www.medworm.com/index.php?rid=1166421&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F220473495%2Fetravine_gets_fda_approval_for.html Tibotec Pharmaceuticals, a division of Ortho Biotech Products, announced that its drug Etravine has received U.S. Food and Drug Administration approval for the treatment of HIV infection in patients who have not responded to other antiretroviral treatments.The tablets sold under the name Intelence consist of a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme that the HIV virus requires to multiply. The FDA approved it for use in combination with other HIV medications.Etravine was given a priority review, status given to medications that treat life threatening conditions. The FDA stated that the drug can reduce the amount of HIV in the blood and increase white blood cells that are needed to fight off other infections."This is another s... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1166421 Mon, 21 Jan 2008 15:00:53 +0100 1166421 http://www.medworm.com/index.php?rid=1155901&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F217683235%2Ftysabri_gets_fda_approval_for.html Biogen Idec Inc. and Elan Corp's Tysabri received U.S. Food and Drug Administration approval to be used in patients with moderate to severe Crohn's disease when standard drug treatments are ineffective.Tysabri was previously FDA approved for the treatment of Multiple Sclerosis but was removed from market in 2005 after three patients using it developed the nervous disorder multifocal leukoencephalopathy (PML). Under restricted distribution the drug was allowed back on the market the following year and Biogen reports that 12,000 MS patients use it with no further reports of the fatal disorder.Crohn's disease patients will have to enroll in a similar distribution program to receive Tysabri. The program consists of educational information regarding the drug'... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1155901 Wed, 16 Jan 2008 14:00:41 +0100 1155901 http://www.medworm.com/index.php?rid=1139828&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F213935760%2Feli_lilly_and_co_gets_fda_appr.html Eli Lilly & Co. (NYSE:LLY) announced that the U.S. Food and Drug Administration has approved two low-dose forms of Cialis for use on a daily basis.Cialis, an anti-impotence drug, will now be available in 2.5 milligram and 5 milligram doses and will allow men more flexibility in the timing of sexual activity."In clinical trials, when taken without restrictions on the timing of sexual activity, Cialis for once daily use improved erectile function over the course of therapy," Lilly said in a release.The low-dose formulations have already been available in parts of Europe but the company warns that even the new reduced dosage makes the medication inappropriate for heart patients who take nitrates. The combination of sildenafil citrate (Viagra), tadalafil (Cialis) or vardenaf... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1139828 Wed, 09 Jan 2008 16:00:26 +0100 1139828 http://www.medworm.com/index.php?rid=1133907&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F212773704%2Fbystolic_gets_fda_approval_for.html Forest Laboratories Inc. (NYSE: FRX) and Mylan Inc. (NYSE: MYL) announced that the U.S. Food and Drug Administration has approved the novel beta blocker Bystolic for the treatment of high blood pressure.Bystolic is a once a day drug that can be used alone or in combination with other hypertension medications in the treatment of high blood pressure. An extensive clinical trial that involved more than 2000 patients, Bystolic showed significant decreases in sitting diastolic and systolic blood pressure. The medication was found to be well tolerated with low incidence of normal beta blocker side effects.Howard Solomon, Chairman and Chief Executive of Forest, commented: "We, along with our partner Mylan, are pleased to have received final Food and Drug Administration marketing approval for... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1133907 Mon, 07 Jan 2008 17:00:11 +0100 1133907 http://www.medworm.com/index.php?rid=1108699&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F203612407%2Ftentative_fda_approval_for_gen_1.html The U.S Food and Drug Administration has announced that it has issued tentative approval for a generic version of Viread (tenofovir disoproxil fumarate). Viread is a drug that is used in combination with other antriretroviral agents in the treamtent of HIV."Tentative approval" means that the product meets all FDA manufacturing standards and safety and efficacy requirements but that existing patents or marketing exclusivity prevents final approval in the U.S at this time.“The fight to save lives with high-quality anti-retroviral treatment is of significant importance to FDA,” said Gary Buehler, director of FDA’s Office of Generic Drugs. “Our scientists have been working diligently to make safe and effective treatments for AIDS available as quickly as possib... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1108699 Thu, 20 Dec 2007 19:00:53 +0100 1108699 http://www.medworm.com/index.php?rid=1103497&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F202250891%2Fforest_labs_and_mylans_bystoli.html Forest Laboratories Inc. (NYSE:FRX) and Mylan Inc.(NYSE:MYL) have received U.S. Food and Drug Administration approval for their beta blocker Bystolic.Bystolic, indicated for the treatment of hypertension, is a one daily medication that can be used in conjunction with other high blood pressure drugs or alone. The drug is a beta blocker which is one of the most prescribed classes of drug in the U.S. In several clinical trials Bystolic showed significant decreases in sitting diastolic and systolic blood pressure in a group of patients that included 26 percent black, 54 percent male, 19 percent elderly and 8 percent diabetic."Bystolic is the newest beta blocker approved for the treatment of hypertension in the U.S. and should prove useful due to its efficacy in a broad range of patie... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1103497 Tue, 18 Dec 2007 15:00:43 +0100 1103497 http://www.medworm.com/index.php?rid=1100156&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F201732157%2Fglaxosmithkline_receives_fda_complete_response_letter_for_cervarix.html GlaxoSmithKline announced that it received a FDA complete response letter with regards to its application for new drug status for Cervarix, a cervical cancer vaccine. A complete response letter is issued when the FDA has completed review of the file but still has unanswered questions prior to final approval."We have already started addressing the questions and will be engaged in discussions with the FDA to finalize our responses," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "Our discussions with the agency continue to be positive and constructive, and we are working diligently to resolve any outstanding questions to bring CERVARIX(R) to the U.S. market."Cervarix, one of the largest drug hopes in Gl... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1100156 Mon, 17 Dec 2007 16:00:45 +0100 1100156 http://www.medworm.com/index.php?rid=1096192&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F200474290%2Fmylan_pharmaceuticals_incs_lam_1.html U.S. Food and Drug Administration today issued tentative approval for Mylan Pharmaceuticals Inc’s Lamotrigine tablets. Lamotrigine is the generic version of GlaxoSmithKline's Lamictal tablets which is an anticonvulsant drug used to treat partial seizures associated with epilepsy. It is also used as a mood stabilizer and was the first drug since lithium granted FDA approval for the maintenance treatment of bipolar type I disorder. It was granted FDA approval for the treatment of epilepsy in 1994 and bipolar I disorder in 2003. Black box warnings include Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis. More common side effects include headaches, dizziness, insomnia, acne, vivid dreams, body aches, fatigue, memory and cognitive problems, irritability, changes in libido, naus... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1096192 Thu, 13 Dec 2007 20:00:54 +0100 1096192 http://www.medworm.com/index.php?rid=1084250&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F198190914%2Ffda_decision_regarding_nexium_and_omeprazole_no_cardiac_risk.html Final assessment of two small, long-term, open studies on patients with gastro-esphogeal reflux disease (GERD) comparing anti-reflux surgery with either Nexium or omeprazole was announced by the U.S. Food and Drug Administration. The FDA concluded that "long-term use of these drugs is not likely to be associated with an increased risk of heart problems. FDA recommends that health care providers continue to prescribe, and patients continue to use, these products as described in the labeling for the two drugs."AstraZeneca, manufacturer of Nexium, agreed with the FDA's findings and further agreed that the overall risk/benefit profiles of omeprazole and Nexium remain unchanged and continues to be confident in the safety of both drugs.AstraZeneca's tradenames for ome... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1084250 Mon, 10 Dec 2007 16:00:44 +0100 1084250 http://www.medworm.com/index.php?rid=1074988&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F196385852%2Fcommitte_votes_to_approve_tetr.html A U.S. Food and Drug Administration advisory committee voted unanimously to recommend approval of tetrabenzine for chorea associated with Huntington disease (HD). If approved it would be the first drug in the U.S. approved for the treatment of chorea. The FDA is not required to follow the suggestions of its advisory committees, however, approval usually follows such a recommendation."The advisory committee's support of tetrabenazine represents an important advancement for Huntington disease patients, caregivers, advocates and physicians who treat this devastating disease," said George F. Horner III, president and chief executive officer of Prestwick. "We are committed to continuing to work with the FDA to secure full approval of tetrabenazine."Huntington disease is ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1074988 Thu, 06 Dec 2007 20:00:47 +0100 1074988 http://www.medworm.com/index.php?rid=1067792&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F194600524%2Fdiovan_gets_fda_approval_for_t.html The U.S. Food and Drug Administration has approved Diovan (valsartan) for use on children between the ages of six and sixteen following a priority review. Diovan is an angiotensin receptor blocker (ARB). The drug has already been previously approved for use by adults suffering from high blood pressure.It is believe that nearly 5% of children and adolescents suffer from high blood pressure. Novartis Pharmaceuticals, the manufacturer of Diovan, claims that studies showed no difference in adverse affects on children than were previously reported for adults. Those side effects can include: headache and dizziness or more seriously hypotension and kidney problems."Novartis believes it is important to provide physicians with treatment options such as Diovan which are effective in treati... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1067792 Mon, 03 Dec 2007 20:00:38 +0100 1067792 http://www.medworm.com/index.php?rid=1062889&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F193074550%2Fcymbalta_gets_fda_approval_as.html The U.S. Food and Drug Administration has approved Cymbalta (duloxetine HCl) for the maintenance treatment of major depressive disorder (MDD) in adults according to the drug manufacturer, Eli Lilly and Company (NYSE:LLY).The efficacy and safety of Cymbalta, as a maintenance treatment, was established in a double-blind, placebo-controlled clinical trial involving 533 patients with major depression. After 12 weeks, 278 patients met the criteria to continue in the trial and were randomly assigned Cymbalta or a placebo for the next six months. Those taking Cymbalta had a statistically longer period of time between relapses."Relapse, the re-emergence of depressive symptoms after a successful treatment of depression, is a significant clinical concern," says Doug Williamson, M.D., ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1062889 Fri, 30 Nov 2007 16:00:59 +0100 1062889 http://www.medworm.com/index.php?rid=1054848&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F191462750%2Ffda_drug_approval_news.html Vanada Pharmaceuticals has announced that its drug, iloperidone, has been accepted for U.S. Food and Drug Administration New Drug Application (NDA). Iloperidone is an investigational atypical antipsychotic for the treatment of schizophrenia.In other FDA news, Watson Pharmaceuticals Inc announced that it received final approval on its ANDA for Oxycodone Hydrochloride and Ibuprofen tablets in the 5/400 mg strengths. Waston's product is the generic equivalent of Forest Laboratories Inc.'s Combunox which is used for the short term (no more than 7 days) treatment of acute, moderate to severe pain.The FDA has accepted filing of a NDA for Schering-Plough's asenapine, a fast-dissolving, sub-lingual tablet for schizophrenia and acute mania associated with Bipolar I Disorder. To dat... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1054848 Tue, 27 Nov 2007 20:00:38 +0100 1054848 http://www.medworm.com/index.php?rid=1054849&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F191438299%2Finomax_by_ikaria_approved_in_australia.html Ikaria Holdings Inc's subsidiary INO Therapeutics LLC announced today that it has received approval from Australia's Therapeutic Goods Administration (TGA) for INOmax (nitric oxide) for inhalation. INOmax stated that it had received Orphan Drug status, a process by which medical products for rare illnesses are approved, which it has already received in the U.S. Europe, Canada, Singapore and several Latin American countries.INOmax is indicated for the treatment of near and full-term newborns suffering from hypoxic respiratory failure (HRF), a life-threatening condition that prevents babies' lungs from delivering sufficient oxygen to their bodies."As we broaden the reach of INOmax to new continents, we are expanding our ability to advance critical care around the globe,&quot... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1054849 Tue, 27 Nov 2007 19:00:19 +0100 1054849 http://www.medworm.com/index.php?rid=1047610&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F189406329%2Ffda_approves_abilify_as_add-on_for_major_depression.html Earlier this month the U.S Food and Drug Administration approved Abilify for the treatment of schizophrenia in teens and have now expanded that approval to include patients with major depressive disorder.Approved in 2002 for schizophrenia in adults and for adults suffering from bipolar manic episodes, Bristol-Myers Squibb states that Abilify is the first drug approved as an adjunctive treatment for major depressive disorder for patients needing more than just antidepressants."The approval of this new add-on treatment option is critical for adults suffering from depression who cannot find sufficient relief for their symptoms with antidepressants alone," commented Madhukar Trivedi, M.D., of the University of Texas Southwestern Medical School in Dallas.Supplemental approva... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1047610 Fri, 23 Nov 2007 15:00:13 +0100 1047610 http://www.medworm.com/index.php?rid=1036940&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F187316051%2Fbayer_and_onyx_nexavar_fda_approved_for_liver_cancer.html Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals, Inc. (Nasdaq: ONXX) have received U.S. Food and Drug Administration supplemental New Drug approval for Nexavar (sorafenib).Nexavar is the first FDA approved drug indicated for the treatment of patients with liver cancer (unresectable hepatocellular carcinoma - HCC). It is an oral anticancer and has shown significant overall survival in patients since it was first used in 2005."The approval of Nexavar in liver cancer marks the second time in two years that this novel kinase inhibitor has been granted FDA approval on a Priority Review basis, making it rapidly available to patients who previously had limited treatment options," said Arthur Higgins, chairman of the Executive Committee of Bayer HealthCare. "This mile... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1036940 Mon, 19 Nov 2007 18:30:35 +0100 1036940 http://www.medworm.com/index.php?rid=1032967&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F185969732%2Ffda_approves_astrazenecas_sero.html The U.S Food and Drug Administration has approved AstraZeneca (NYSE:AZN)Seroquel XR for maintenance treatment of schizophrenia in adult patients. Seroquel XR was previously approved for the treatment of acute schizophrenia in May of this year. According to PRNewsIn the clinical trial supporting this approval, patients with schizophrenia who were treated with SEROQUEL XR experienced a significantly longer time to relapse, compared with patients receiving placebo. Patients receiving SEROQUEL XR demonstrated an 84% reduction in the relative risk of relapse (hazard ratio 0.16; p<0.0001). Results showed the estimated risk of relapse after six months was 14.3% in the SEROQUEL XR group versus 68.2% in the placebo group (p<0.0001). Differences in relapse rate between active treatment an... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1032967 Fri, 16 Nov 2007 20:00:46 +0100 1032967 http://www.medworm.com/index.php?rid=1021309&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F183646737%2Ffda_approval_for_nonprescripti.html Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg), an allergy drug, has been approved for nonprescription use in adults and children over the age of 12 by the U.S. Food and Drug Administration.Previously approved by the FDA in 2001 as a prescription drug, Zyrtec-D is now available without a prescription. It is indicated for the relief of symptoms due to hay fever or other upper respiratory allergies like runny nose, sneezing, itchy andwatery eyes, itching of nose or throat and nasal congestion. It also reduces the swelling of nasal passages for the relief of sinus congestion and pressure.National Institute of Allergy and Infectious Diseases estimates that 50 million Amaericans suffer from hay fever and allergies every year and is the sixth leading cause of chronic disease.&quot... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1021309 Mon, 12 Nov 2007 16:30:45 +0100 1021309 http://www.medworm.com/index.php?rid=1021310&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F183625480%2Fclogged_arteries_take_crestor.html AstraZeneca plc (NYSE:AZN) has received U.S. Food and Drug Administration approval to sell its cholesterol drug, Crestor, to also treat clogged arteries. Crestor will now be available to treat atherosclerosis in addition to being used as to lower cholesterol. It is the first widely used statin to receive this new approval.AstraZeneca has been conducting a large number of clinical trials to prove that it is superior to other statins. "This new indication gives Crestor an important differentiator from competitors in the cholesterol-lowering marketplace," AstraZeneca said in a statement.The new FDA approval is expected to give Crestor a leg up over competitors in the cholesterol lowering market like Lipitor from Pfizer Inc."FDA today approved Crestor as adjunctive therapy to di... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1021310 Mon, 12 Nov 2007 15:30:06 +0100 1021310 http://www.medworm.com/index.php?rid=1012381&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F181193627%2Fatir_from_kiadis_pharma_gets_o.html The U.S. Food and Drug Administration has granted orphan drug status to Kiadis Pharma for its lead drug ATIR.ATIR is currently in Phase I/II clinical studies as a therapy for immune reconstitution and prevention of Graft vs Host Disease (GvHD) following allogenic bone marrow transplantation. The drug is expected to go into Phase III trials in 2008."This is an important strategic milestone in the development of ATIR as a novel approach which may enable a safe and potentially life-saving mismatched bone marrow transplantation as a treatment option for end-stage blood cancer patients" said Dr. Manja Bouman, Chief Executive Officer of Kiadis Pharma.GvHD is one of the biggest concerns during any bone marrow transplant. It is a condition where the donor's immune cells and attack th... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1012381 Wed, 07 Nov 2007 16:30:38 +0100 1012381 http://www.medworm.com/index.php?rid=1009446&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F180742700%2Fabilify_fda_approved_for_teens.html Bristol-Myers Squibb (NYSE:BMY) announced that the U.S Food and Drug Administration has approved its drug Abilify for teens aged 13 - 17 that have been diagnosed with schizophrenia.Abilify (aripiprazole) is an antipsychotic drug that was first approved by the FDA at the end of 2002 for adults with schizophrenia and since that time Bristol-Myers says that more than 12.5 million US prescriptions for the drug have been written."We are extremely pleased that ABILIFY, the first available dopamine partial agonist, is approved for the treatment of pediatric patients (13 to 17 years of age) suffering from schizophrenia," said Tatsuo Higuchi, President and Representative Director, Otsuka Pharmaceutical Co., Ltd. "ABILIFY® (aripiprazole) offers an effective new option to help... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1009446 Tue, 06 Nov 2007 20:30:44 +0100 1009446 http://www.medworm.com/index.php?rid=1001033&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F178819114%2Fthe_us_food_and_drug.html The U.S. Food and Drug Administration has accepted Indevus Pharmaceuticals Inc.'s (NASDAQ:IDEV)  New Drug Application (NDA) for Nebido. The NDA was submitted August 28, 2007 and the target action date for the drug is June 27, 2008. Nebido is a long-acting testosterone injection for the treatment of hypogonadism. The NDA contained data from six clinical trials of over 3,000 injections as well as data from 260,000 injections worldwide. Hypogonadism is a medical condition in which there is an absence or reduction of testosterone in the testes. Reduced testosterone levels can lead to decreased sexual desire, muscle loss and weakness and the increased risk of osteoporosis. It is estimated that four to five million men in the U.S. suffer from hypogonadism and less than 10% are rece... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1001033 Fri, 02 Nov 2007 17:15:44 +0100 1001033 http://www.medworm.com/index.php?rid=995006&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177853452%2Fcombigan_eye_drop_for_galucoma_fda_approved.html The U.S. Food and Drug Administration has approved Combigan by Allergan Inc.(NYSE:AGN) for the treatment of glaucoma. It is a prescription eye drop that reduces elevated intraocular pressure (IOP) using an alpha adrenergic receptor agonist with a beta adrenergic inhibitor."COMBIGAN(TM) ophthalmic solution is a medication that provides well documented safety and efficacy for patients with inadequately controlled IOP," said Scott Whitcup, M.D., Allergan's Executive Vice President, Research and Development. "The development of COMBIGAN(TM), which has included five key clinical studies, underscores Allergan's commitment to provide new treatment options for patients with glaucoma." Glaucoma is a group of eye diseases that are characterized by damage to the optic... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=995006 Wed, 31 Oct 2007 20:00:46 +0100 995006 http://www.medworm.com/index.php?rid=991867&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177259353%2Fadams_respitory_therapeutics_gets_approval_letter_for_mucinex_with_codeine.html The U.S Food and Drug Administration has issued a letter of approval regarding the New Drug Application for Adams Respitory Therapeutics Inc's (NASDAQ:ARXT) Mucinex with Codeine.Mucinex with Codeine is to be used in the prescription treatment of cough associated with the common cold, inhaled irritants and stable chronic bronchitis.The FDA stated that it had it had completed its review of the medication and that it was approvable however prekiminary labeling comments are required in addition to more data on the use of the product with food."An approvable letter for Mucinex with Codeine is a positive step in the FDA review process," said COO Robert D. Casale. "As a next step, we intend to seek a meeting with the agency in order to agree on an approach. We wi... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=991867 Tue, 30 Oct 2007 17:15:31 +0100 991867 http://www.medworm.com/index.php?rid=991869&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F177201169%2Fnovartis_ag_gets_fda_approval_1.html Novartis AG (NYSE:NVS) has received U.S. Food and Drug Administration approval for Tasigna.Tasigna is indicated for use in chronic myeloid leukemia for patients that no longer respond to Glivec(Gleevec in the US). It was developed as a next-generation targeted therapy for adult patients with chronic or accelerated phase Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) with intolerance and/or resistance to Gleevec.Both Tasigna and Gleevec were designed to inhibit the production of cells containing the Philadelphia chromosome by inhibiting the Bcr-Abl protein which is recognized as the key cause of the proliferation of white blood cells that characterizes Ph+CML."These exciting data demonstrate that Tasigna has the potential to offer a compelling new treatment ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=991869 Tue, 30 Oct 2007 15:15:12 +0100 991869 http://www.medworm.com/index.php?rid=988451&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F176777581%2Ftentative_approval_for_valsart.html Ranbaxy Pharmaceuticals announced that it has received tentative approval to manufacture and market Valsartan Tablets in 40 mg, 80 mg, 160 mg and 320 mg strengths.Valsartan is the generic version of Diovan, a Novartis drug, and is used in the treatment of high blood pressure. I tcan be used alone or in combination with other anti-hypertensive medications. It is also indicated for the treatment of heart failure."We are pleased to receive tentative approval for Valsartan Tablets. We believe, we are first to file a substantially complete ANDA and will stand to gain from the 180 day exclusivity available to the first filer. These product formulations have been developed organically within Ranbaxy and will further expand our product portfolio of affordable generic alternatives," said ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=988451 Mon, 29 Oct 2007 18:15:13 +0100 988451 http://www.medworm.com/index.php?rid=979218&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F174962703%2Fsanofiaventis_receives_warning.html The FDA sent a warning letter to Sanofi's CEO Gregory Irace accusing the company of knowingly having submitted clinical data had "multiple and significant violations of FDA regulations… that affected the integrity of data submitted".After the FDA required more information on Ketek following fears that it could cause liver damage, data obtained as part of a postmarketing study by Pharmaceutical Product Development was submitted on behalf of Aventis prior to its merge with Sanofi-Synthelabo.At the heart of the matter is Dr Anne Kirkman-Campbell who in 2004 was convicted of fraud regarding patient enrollment and fake consent forms during the Ketek study. The issue also raised concerns in Congress and a former Pharmaceutical Product Development employee testified that... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=979218 Thu, 25 Oct 2007 18:15:14 +0100 979218 http://www.medworm.com/index.php?rid=976396&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F174474669%2Fwyeth_applies_to_fda_approval_for_new_drug_tygacil.html Wyeth Pharmaceutical (NYSE:WYE) announced that the FDA has accepted the filing of Tygacil (tigecycline) for new drug approval. Tygacil is a first-in-class antibiotic for the treatment of patients with community acquired pneumonia.The next step is for the FDA to review the application and either approve or disapprove the request. It may also request additional data or take other actions."CAP is a serious respiratory disease that affects millions of Americans," says Gary L. Stiles, M.D., Executive Vice President, Chief Medical Officer, Wyeth Pharmaceuticals. "The acceptance of this sNDA is an important event as it brings Wyeth closer to providing physicians with a new option for the treatment of CAP."The submission included data from two clinical studies of 846 ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=976396 Wed, 24 Oct 2007 19:15:28 +0100 976396 http://www.medworm.com/index.php?rid=972759&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F173940137%2Fnovartis_ag_gets_fda_approval.html The U.S Food and Drug Administration has given approval to Novartis AG (NYSE:NVS) for Voltaren Gel, a non-steriodal anti-inflammatory (NSAID) medication for osteoarthritic pain.The gel can be applied directly to joints, such as knees, hands, elbows, to relieve the pain assosciated with osteoarthritic pain. Osteoarthritis is a chronic condition in which the cartilage of the joints deteriorates. "Voltaren Gel represents an important clinical milestone - it is the first prescription topical treatment in the US shown to relieve osteoarthritis pain and to clinically prove efficacy in treating both the knees and hands," said Jorge Insuasty, MD, Senior Vice President, Research and Development, Novartis Consumer Health, Inc. "Patients now have the option to effectivel... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=972759 Tue, 23 Oct 2007 19:15:11 +0100 972759 http://www.medworm.com/index.php?rid=972762&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F173837388%2Fsun_pharmaceutical_industries_gets_fda_approval_to_market_generic_exelon.html Sun Pharmaceutical Industries (BOM:524715) announced that it has received U.S. Food and Drug Administration final approval to market the generic version of Exelon capsules.Exelon (rivastgmine tartrate) is a pharmaceutical drug manufactured by Novartis that helps slow down the progress of Alzheimer's disease and for mild to moderate Parkinson's disease dementia.Alzheimer's disease is a progressive, degenerative disease that causes changes in the brain. A type of dementia, it affects a person's memory, mood and behavior. Most commonly affecting people over the age of 65, its cause is unknown but plaques form in the brain causing a disruption in the flow of information between neurons. Exelon is a cholinesterase inhibitor that works by increasing the amount of a... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=972762 Tue, 23 Oct 2007 15:15:27 +0100 972762 http://www.medworm.com/index.php?rid=970104&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F173458404%2Ffda_expands_age_range_for_mena.html The bacterial meningitis vaccine, Menactra has been now been approved for use on people between the ages of 2 and 10 years. The FDA has previously approved Menactra, in 2005, for people between the ages of 11 and 55. Meningitis is an inflammation of the lining that surrounds the spinal cord and brain and can result in death or permanent injury to the brain and nervous system. An estimated 2,600 people in the U.S. contract meningitis annually and about 10% die.“Approving Menactra for younger children offers another option for health care providers and parents. Now there are two vaccines available for children between 2 and 10 years of age who may be at increased risk of meningitis,” said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation a... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=970104 Mon, 22 Oct 2007 21:30:38 +0100 970104 http://www.medworm.com/index.php?rid=964604&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F172205606%2Ffda_approves_doribax.html Doribax, an intravenous infusion that has been shown to be affective against several strains of bacteria, has been approved by the U. S. Food and Drug Administration.The doripenem injection is indicated for the treatment of complicated urinary tract infections and intra-abdominal infections. “This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.In multi-center studies, doripenem has a cure rate comparable to the currently used medication levofloxacin. Common adverse reactions were headache, nausea, diahhrea, rash and plebitis. Should an allerigic ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=964604 Fri, 19 Oct 2007 19:15:01 +0100 964604 http://www.medworm.com/index.php?rid=958915&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F171239793%2Fixempra_by_bristol-myers_squibb_approved_by_fda_for_breast_cancer_.html Ixempra, a new chemotherapy drug from Bristol-Myers Squibb (NYSE:BMY), has been approved for sale by the U.S. Federal Drug Administration and is expected to be available for sale within the next few days.Ixempra, a new class of drugs called epothilones, is a stand alone treatment for women with advanced breast cancer that has not responded to other anthracyclines or taxanes."We now have an important new option for patients with metastatic breast cancer who have rapidly progressed through currently approved chemotherapies," Dr. Linda Vahdat, a cancer expert at New York-Presbyterian Hospital/Weill Cornell Medical Center, said in a Bristol-Myers statement.Patients who took Ixempra with Xeloda, in clinical trials, had tumors that either shrank or did not grow for an average... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=958915 Wed, 17 Oct 2007 19:30:34 +0100 958915 http://www.medworm.com/index.php?rid=956131&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F170721317%2Fglaxosmithkline_gets_fda_appro.html The FDA approved GlaxoSmithKline's (NYSE:GSK) oral Hycamtin (topotcan) for the treatment of relapsed small cell lung cancer. The capsules are indicated for patients who had a complete or partial response to chemotherapy and who are at least 45 days from the end of their treatment."The approval of HYCAMTIN capsules is particularly important forpatients with relapsed small cell lung cancer as they now have an effective treatment option that has been shown to provide a survival benefit and can be conveniently taken at home," said Debasish Roychowdhury, M.D., Vice President, Global Clinical Development, Oncology Medicine Development Center, GSK.Small Cell Lung Cancer (SCLC) is caused by uncontrollable growth of cancer cells on the bronchi and tends to spread to the rest of the bo... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=956131 Tue, 16 Oct 2007 17:45:20 +0100 956131 http://www.medworm.com/index.php?rid=948591&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F169476649%2Fmerck_cos_aids_pills_approved_by_fda.html The FDA has approved Merck & Co.'s (NYSE:MRK)newest AIDS option, Isentress and the company said that the pill should be available to the public within the next two weeks.Three different enzymes are used by the AIDS virus to reproduce and infect cells and numerous drugs are available that attack two of those enzymes, protease and reverse transcriptase. Isentress is the first in a new class of medication that blocks the third called integrase. When Isentress (raltegravir) is added to the drug "cocktail", it can lower the amount of HIV in the blood and thus help immune cells rebound. Inhibiting integrase from allowing HIV DNA insertion into human DNA blocks the ability of the virus to replicate and infect new cells.The FDA approved the use of Isentress for use of patien... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=948591 Sat, 13 Oct 2007 19:36:22 +0100 948591 http://www.medworm.com/index.php?rid=941865&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F167996160%2Fglenmark_pharmaceuticals_limited_receives_fda_approval_to_market_generic_version_of_trileptal_.html Glenmark Pharmaceuticals Limited (NSE:GLENMARK)has received final U.S. Food and Drug Administration approval to market generic Trileptal (Oxcarbazepine) tablets.Trileptal is currently manufactured by Roxane Laboratories Inc (Google Finance), Glenmark Pharmaceuticals Ltd. and Sun Pharmaceutical Industries Limited (BOM:524715) in three strength (150 mg, 300 mg and 600 mg) and is used alone or in combination with other drugs in the treatment of partial epileptic seizures in adults and children over the age of 4.Trileptal was the 74th best selling brand name medication in 2005 according to Drug Topics."FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs," said Gary J. Buehler, director of FDA's Office of Generic Drugs.... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=941865 Wed, 10 Oct 2007 17:00:36 +0100 941865 http://www.medworm.com/index.php?rid=938781&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F167504668%2Fteva_pharmaceutical_industries.html Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that it has received final FDA approval for its Abbreviated New Drug Application for the generic version of Actonel.Actonel, a Procter & Gamble Company (NYSE:PG) product, is used in the treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis and for the treatment of Paget's disease.Teva is currently in patent litigation concerning the generic version of Actonel. A trial was held in November 2006 but no decision has been rendered. As part of the litigation Teva agreed to give a 30 day notice to Procter and Gamble prior to any launch of the product. Notice has not yet been given.Teva has been awarded 180 days marketing exclusivity for being the first company to file an Abbreviated New Dr... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=938781 Tue, 09 Oct 2007 17:00:03 +0100 938781 http://www.medworm.com/index.php?rid=935294&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F166978293%2Feuropean_approval_for_novatis.html Novartis AG (NYSE:NVS) has received European approval for its drug Aclasta for postmenopausal osteoporosis. The treatment is taken once a year and has been shown to reduce fractures normally affected by osteoporosis such as spine, wrists and hips. Belonging to a drug family called bisphosphonates, it has long been used to treat the osteoporosis which affects over 94 million people in the E.U. and U.S.Aclasta is given as an annual 15 minute, to fight osteoporosis, which is a symptom of aging. The bones start to become less dense, later in life, and that increases the risk of fracture. Typically women suffer from it more than men. Aclasta, marketed as Reclast in the U.S. has already received FDA approval."Aclasta is highly effective at reducing fractures and can be given once-... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=935294 Mon, 08 Oct 2007 15:00:17 +0100 935294 http://www.medworm.com/index.php?rid=931166&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F165859967%2Faptivus_tipranavir_gets_full_fda_approval.html Boehringer Ingelheim Pharmaceuticals Inc. announced that it has received full approval from the FDA for Aptivus. It had already received accelerated approval in June of 2005. Full approval was granted on data from a 48-week analysis of the Phase 3 clinic studies."Data show that APTIVUS/r may provide treatment-experienced HIV patients with an effective treatment option through nearly one year of therapy. Furthermore, longer-term safety data are now available for physician and patient consideration," said Dr. Daniel Kuritzkes, associate professor of medicine, Harvard Medical School; director of AIDS research, Brigham and Women's Hospital, Boston, MA.Aptivus has already been approved in Argentina, Australia, Canada, Switzerland, Mexico, Iceland, Taiwan and the European Unio... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=931166 Fri, 05 Oct 2007 21:00:17 +0100 931166 http://www.medworm.com/index.php?rid=931168&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F165814298%2Ftentative_fda_approval_for_tev.html Teva Pharmaceutical Industries Ltd. (NASDAQ:TEVA) announced that it has received tentative approve for its generic version of Valtrex. Manufactured by GlaxoKleinSmith, the patent for Valtrex expires in December and final approval for the generic version is expected at that time. Mylan Laboratories Inc. (NYSE:MYL) has also received tentative FDA approval for generic Valtrex. Valtrex is used in the treatment of herpes zoster (shingles), genital herpes and herpes labialis (cold sores). Total sales of Valtrex were about $1.3 billion last year.   (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=931168 Fri, 05 Oct 2007 19:00:02 +0100 931168 http://www.medworm.com/index.php?rid=931169&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F165789583%2Ftentative_fda_approval_for_gen.html Caraco Pharmaceuticals (AMEX:CPD)  announced today that they have received tentative approval to market their generic version of Zyrtec Chewable, Cetirizine HCl Chewable. They are expecting final approval prior to the expiration of the patent in December of this year.Cetirizine HCl Chewable is used for the relief of nasal symptoms of seasonal allergies and is the bioequivalent of Pfizer Inc's Zyrtec Chewable which has U.S. sales of $75 million from June 2006 to June 2007.Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are extremely pleased to receive this tentative approval and look forward to the expiration date of the patent on December 25, 2007, which will allow Caraco to market the product. We feel that Cetirizine HCl Chewable complements our previo... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=931169 Fri, 05 Oct 2007 18:00:49 +0100 931169 http://www.medworm.com/index.php?rid=925341&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F164772674%2Ffda_approves_evista_raloxifene_1.html The FDA has approved Raloxifene as a treatment to reduce breast cancer risk in menopausal women. Raloxifene, under the brand name Evista, has previously been approved for postmenopausal women with osteoporosis but is now available to women with high risk for invasive breast cancer. Based on clinical studies of postmenopausal women over a 10 year period of time, raloxifene "provides an important new option for women at heightened risk of breast cancer," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=925341 Wed, 03 Oct 2007 17:30:40 +0100 925341 http://www.medworm.com/index.php?rid=918931&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F164163860%2Ffda_approves_lamisil_for_scalp.html The FDA has approved the use of Lamisil Oral Granules in the treatment of scalp ringworm, tinea capitis, in children over the age of 4."Tinea capitis is a persistent infection that is hard to treat, and one that causes children embarrassment," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research. "A parent's ability to sprinkle it on the food of a child, who may not like to take medicine, should go a long way to helping ensure the infection is properly treated and to limiting its spread." Lamisil is a Novartis Pharmaceuticals product. The company was approached by the FDA for a formulation that would appeal to children. Novartis developed the granules which can be sprinkled on food.  (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=918931 Mon, 01 Oct 2007 22:15:14 +0100 918931 http://www.medworm.com/index.php?rid=918020&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F163819243%2Ftaxotere_gets_fda_approval_to.html Sanofi-Aventis (EPA:SAN) has announced that the FDA has approved Taxotere™  for use in cancer patients with carcinoma of the head and neck prior to chemotherapy or surgery.A clinical trial found that patients receiving a combination of Taxotere-based therapy (TPF) and cisplatin and 5-flurouracil (PF) has a 30% lower risk of death than those receiving PR alone. Patients treated with TPF has an average overall survival of 70.6 months as compared to 30.1 months for those getting PF.Clinical investigator Marshall Posner, MD, Medical Director of the Head and Neck Oncology Program at Dana-Farber Cancer Institute in Boston stated "The approval of Taxotere to be given in combination with other standard chemotherapy as the first step in a therapeutic sequence followed by c... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=918020 Mon, 01 Oct 2007 17:00:27 +0100 918020 http://www.medworm.com/index.php?rid=911902&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F162637594%2Fethicon_endo-surgery_inc_gets_fda_approval_for_realize_gastric_band.html The FDA issue approval on Ethicon Endo-Surgery Inc. Realize™ Gastric Band. Realize™ Adjustable Gastric Band is a surgical implant for weight reduction in obesity related health conditions. In a 3 year study of 276 patients, those using the Realize(TM) Band saw an average of 42.8 percent weight loss. Thirty-five percent hose who completed the trial had a 50% more loss of weight while 10.5% lost 75% or more in excess body weight. Ed Phillips, MD, FACS, principal investigator in the REALIZE Band clinical trial and Director of the Center for Minimally Invasive and Bariatric Surgery at Cedars-Sinai Medical Center in Los Angeles said "This procedure, combined with the proper support system and a commitment to dietary and lifestyle changes after surgery helped these pat... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=911902 Fri, 28 Sep 2007 21:10:41 +0100 911902 http://www.medworm.com/index.php?rid=911904&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F162491739%2Funapproved_hydrocodone_products_marketing_stopped_by_fda.html The FDA announced that it will take enforcement action against companies who manfucture unapproved prescription drug products that contain hydrocodone.Hydrocodone, one of the strongest pain relief and cough suppressants, can result in breathing problems or cardiac arrest when used improperly. Manufacturing and distribution of unapproved hydrocodone products to children under the age of 6 must end by October 31, 2007. Marketing of other unapproved hydrocodone products must cease being produced by December 31, 2007 and must cease to be shipped by March 31, 2008. The FDA warns that legal action could be taken against those who do not comply by failing to meet the deadlines. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=911904 Fri, 28 Sep 2007 16:10:33 +0100 911904 http://www.medworm.com/index.php?rid=908617&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F162097534%2Fdaiichi_sankyo_inc_gets_fda_ap.html Daiichi Sankyo Co. (TYO:4568) announced today that it has received FDA approval for AZOR.AZOR, amlodipine and olmesartan medoxomil, is used in the treatment of hypertension also referred to as high blood pressure. A once daily pill that is a combination of calcium channel blocker and angiotensin receptor blocker."AZOR with its established efficacy and favorable side effect profile provides twocomplementary mechanisms of action to lower blood pressure. It will givephysicians a new treatment option for patients whose blood pressure remainstoo high on currently prescribed medications" stated Michael A. Weber, MD, Professor of Medicine, State University of New York, Downstate College of Medicine.Hypertension is estimated to affect as many as one in three Americans. It is estimated th... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=908617 Thu, 27 Sep 2007 18:30:17 +0100 908617 http://www.medworm.com/index.php?rid=906104&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F161585989%2Ffda_approval_for_watson_pharma.html Watson Pharmaceuticals announced that it has received final FDA approval for its generic drug, Accuneb. Accuneb is an alubterol sulfate inhalation solution, the generic equivalent of Dey, L.P.’s AccuNeb Inhalation Solution, is used for relief of bronchospam in patients between the ages of 2 and 12 with asthma.Watson has secured a six month market exclusivity from the date of commercial launch which Watson plans to do immediately.Watson Pharmaceuticals Inc. is headquartered in Corona, CA. It is a leading specialty pharmaceutical company that develops, manufactures markets and sells brand and generic drugs. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=906104 Wed, 26 Sep 2007 16:00:29 +0100 906104 http://www.medworm.com/index.php?rid=896075&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F160671176%2Fpfizer_aids_drug_celsentri_get.html Pfizer Inc. has announced that it has received European Commission approval for its AIDS drug Celsentri. The drig, generically known as Maraviroc is the first in a class of oral HIV medicine in more than 10 years.Celsentri, discovered and developed by Pfizer UK blocks viral entry of the HIV virus into the white blood cells. IT will be made available to HIV patients in the EU in combination with other antiretroviral medications. Maraviroc prevents the virus from entering white blood cells by blocking its main entry route, the CCR5 co-receptor rather than fighting HIV inside the white blood cells.Maraviroc, known as Selzentry in the United States, was approved by the U.S. Food and Drug Administration (FDA) on August 6, 2007 and is currently available in the U.S. [Source: Gay Wired]... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=896075 Mon, 24 Sep 2007 17:30:11 +0100 896075 http://www.medworm.com/index.php?rid=891626&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F159571523%2Fincreased_dosage_of_norditropi_1.html Novo Nordisk A/S announced that it has received approval for its drug, Norditropin, from the FDA. Norditropin is for use on children with Turner's Sydrome. Turner's Syndrome is a rare chromosomal condition that is caused by a complete or partial lack of the X chromosome in girls. Short stature is the most common feature of Turner's and Norditropin targets this. Results from a clinical trial found that 80% of patients receiving a higher than previously approved dosage reach normal adult height."Turner syndrome is a rare chromosomal disorder of females characterizedby short stature and the lack of sexual development at puberty. Amongaffected females, physical features may include a short neck with a webbedappearance, heart defects, kidney abnormalities and various other... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=891626 Fri, 21 Sep 2007 19:00:35 +0100 891626 http://www.medworm.com/index.php?rid=886292&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F159005866%2Ffda_approves_flumist_for_child_1.html MedImmune Inc. announced that the FDA has now approved FluMist™ for use in children as young as 24 months. The expansion in age now allows for FluMist™ to be used on people from ages 2 - 59. FluMIst(TM) is an Intranasal Influenza Virus Vaccine that is approved for immunization against influenza A and B. A study of over 4,000 children between the ages of two and five saw a 54% decrease in cases of the flu in children who received FluMIst™ as opposed to those that received a traditional flu shot. FluMist differs from the traditional flu shot in that it consists of live, weakened viruses that help stimulate an immune response to influenza. Pedro Piedra, M.D., professor, Department of Molecular Virology and Microbiology, and Pediatrics, Baylor College of Medicine said &q... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=886292 Thu, 20 Sep 2007 13:56:37 +0100 886292 http://www.medworm.com/index.php?rid=885396&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F158640946%2Ftraumacure_inc_woundstat_1.html TraumaCure Inc. received news that the FDA has cleared its product, WoundStat™, after only six weeks of review.WoundStat™, a lightweight, pre-mixed dressing compound, has been scientifically proven to control high pressure bleeding in moderate to severe wounds.  "The FDA's speedy approval of WoundStat means that we can get it more quickly into the hands of those who need it most today -- our war fighters in harm's way around the world." said Devinder S. Bawa, chief executive officer of TraumaCure, the developer of WoundStat. "The products effectiveness is particularly important with core body wounds that a tourniquet can't reach. We believe that WoundStat has the potential to provide the military with another important tool to minimize ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=885396 Wed, 19 Sep 2007 18:24:26 +0100 885396 http://www.medworm.com/index.php?rid=604129&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F115587431%2Ffirst_parkinsons_disease_patch.html Manufactured by Schwarz Bioscience of Research Triangle Park, N.C. - Neupro® (rotigotine transdermal system), a skin patch designed to treat symptoms of early Parkinson's disease – has been approved by the USFDA. Neupro - the first transdermal patch approved for the treatment of symptoms of Parkinson's disease – contains the drug rotigotine (not previously approved in the U.S.) is a member of the dopamine agonist class of drugs and is delivered continuously through the skin (transdermal) using a silicone-based patch that is replaced every 24 hours. Schwarz Bioscience is the U.S. Subsidiary of Schwarz Pharma AG of Monheim, Germany. Read the full report. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=604129 Thu, 10 May 2007 12:13:57 +0100 604129 http://www.medworm.com/index.php?rid=604130&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F115243944%2Fusfda_gave_final_approval_to_l.html Lupin Pharmaceuticals, Inc. has been granted final approval by the USFDA for its Abbreviated New Drug Application for Cefdinir for Oral Suspension, 250 mg/5mL. Lupin was the first company to receive FDA final approval for the capsule form on (May 19, 2006) and the lower strength suspension (on May 31, 2006) of Cefdinir. Lupin's Cefdinir capsules and suspensions are the AB-rated generic equivalent of Abbott Laboratories' Omnicef® which had U.S. sales of approximately $787 million for the 12-month period ending December 31, 2006, according to IMS Health. Cefdinir is indicated for the treatment of patients with mild to moderate infections caused by susceptible bacteria. Commercail shipment of Cefdinir for Oral Suspension, 250 mg/5mL in the U.S. has already started. Lupin Pharmace... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=604130 Wed, 09 May 2007 05:44:07 +0100 604130 http://www.medworm.com/index.php?rid=604131&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F115234035%2Fus_senate_blocked_efforts_to_a.html Hugely favoring the pharmaceutical industry, the U.S. Senate killed the drive that would have allowed consumers to buy prescription drugs from abroad that is a lot cheaper than domestic prices. Prices of branded prescription drugs in the United States are among the highest in the world. Usually, the cost overseas is only 2/3 of the price in the U.S. The US Senate voted 49-40, requiring the administration to certify the safety and effectiveness of imported drugs before they can be imported. This requirement is something that the officials said they cannot meet. Advocates of drug importation believed for years that an existing ban is more a protection for the drug industry than a safety issue. According to Sen. David Vitter (R., La.): "Well, once again the big drug companies have pro... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=604131 Wed, 09 May 2007 04:33:01 +0100 604131 http://www.medworm.com/index.php?rid=604133&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F114998453%2Fctis_pixantrone_received_usfda.html The USFDA has awarded a Fast Track Designation to Cell Therapeutics, Inc. (CTI) (Nasdaq: CTICD)’s pixantrone for relapsed indolent non-Hodgkin's lymphoma (NHL). Pixantrone is a novel anthracenedione, being investigated by CTI for the potential treatment of relapsed or refractory indolent non-Hodgkin's lymphoma (NHL) that has shown potential (from phase I and phase III studies) in the treatment of relapsed or refractory indolent NHL. Relapsed or refractory indolent NHL is a serious and life threatening condition and is generally considered incurable. According to James A. Bianco, M.D., President and CEO of CTI: "With fast track designation already granted for pixantrone in aggressive NHL, this designation for indolent NHL is an important step in the development of this pr... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=604133 Tue, 08 May 2007 09:18:22 +0100 604133 http://www.medworm.com/index.php?rid=604135&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F114969525%2Fabbott_seeks_approval_of_first.html Abbott (NYSE: ABT) has simultaneously submitted regulatory applications for its drug product HUMIRA® (adalimumab): a supplemental Biologics License Application (sBLA) with the USFDA seeking approval to market HUMIRA® (adalimumab) as a treatment for juvenile rheumatoid arthritis (JRA) in the U.S. a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for juvenile idiopathic arthritis (JIA) in the European Union (EU). The above regulatory applications are the first pediatric indication being sought for HUMIRA®. JRA, commonly referred to as JIA in the EU, is the most common form of arthritis in children and normally begins before the age of 16. Typical symptoms include persistent joint pain and stiffness tha... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=604135 Tue, 08 May 2007 06:16:36 +0100 604135 http://www.medworm.com/index.php?rid=591024&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F114378594%2Ffirst_lowmolecularweight_hepar.html The USFDA has approved a new indication for FRAGMIN® (dalteparin sodium injection): extended treatment of symptomatic venous thromboembolism (VTE) [proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)] to reduce the recurrence of VTE in cancer patients. In the United States, FRAGMIN is also indicated for the following:prevention of DVT, which may lead to PE (pulmonary embolism), in patients undergoing hip replacement surgery, in at- risk patients undergoing abdominal surgery and in at-risk acutely ill patients whose mobility is severely restrictedprophylaxis of ischemic complications resulting from unstable angina and non- Q-wave myocardial infarction (heart attack), when used with aspirinExclusively licensed by Eisai, Inc. from Pfizer, Inc. for U.S. distribution, FRAGMIN... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=591024 Sat, 05 May 2007 15:00:31 +0100 591024 http://www.medworm.com/index.php?rid=588311&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F113760964%2Fdurameds_enjuvia_tablets_recei.html Duramed Pharmaceuticals, Inc. has recently announced the two new USFDA approvals given to ENJUVIA™ (synthetic conjugated estrogens, B) product: supplemental New Drug Application (sNDA) for 0.9 mg tablet strength, which will be added to the Company's existing ENJUVIA product line that includes the 0.3 mg, 0.45 mg, 0.625 mg, and 1.25 mg tablet dosage strengths. ENJUVIA™ is also the first and only oral estrogen that has been approved by FDA to treat moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal atrophy, associated with menopause. ENJUVIA™, a plant-derived formulation, contains a blend of 10 synthetic estrogenic substances including delta 8,9 -dehydroesterone sulfate (DHES) which utilizes a unique delivery system, consisting... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=588311 Thu, 03 May 2007 02:25:26 +0100 588311 http://www.medworm.com/index.php?rid=588312&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F113749598%2Fcsl_behrings_humatep_usfdaappr.html The USFDA has approved CSL Behring’s factor replacement therapy for the treatment of hemophilia A and von Willebrand disease (VWD) - Humate-P® (Antihemophilic Factor/von Willebrand Factor Complex [Human]) – for the prevention of excessive bleeding during and after surgery in VWD patients. Caused by a deficiency or abnormality of the von Willebrand factor (a protein in the blood that is necessary for normal blood clotting), Von Willebrand disease is the most common hereditary bleeding disorder in the United States. According to Garrett E. Bergman, M.D., Senior Director Medical Affairs, U.S. Commercial Operations at CSL Behring (5950871): "For individuals with VWD, the most common inherited bleeding disorder, even minor surgery can present serious risks and require speci... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=588312 Thu, 03 May 2007 01:19:34 +0100 588312 http://www.medworm.com/index.php?rid=574094&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F112395274%2Feli_lillys_canine_separation_a.html The USFDA has approved the marketing of Eli Lilly and Company (NYSE: LLY)’s treatment for canine separation anxiety in conjunction with behaviour modification training: Reconcile™. Reconcile™ (fluoxetine hydrochloride), the first selective serotonin reuptake inhibitor (SSRI) class of antidepressants approved by the FDA for treatment of canine separation and is the first Lilly product approved by the FDA for dogs and is now available to U.S. veterinarians. Reconcile™ is a once-daily, chewable, flavored tablet that may be prescribed by a veterinarian in weight-specific doses for use in conjunction with behavior modification training to treat canine separation anxiety. The drug is proven safe for dogs and puppies 6 months or older. Find more details from the press rele... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=574094 Fri, 27 Apr 2007 10:40:08 +0100 574094 http://www.medworm.com/index.php?rid=571385&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F112120430%2Fusfda_gave_go_signal_to_exelix.html The USFDA has granted Exelixis, Inc. (Nasdaq: EXEL) the go signal to initiate its clinical trial (following approved review of the protocol) of XL999 in patients with non-small cell lung cancer (NSCLC). Developed by Exelixis, XL999 is a potent inhibitor of key receptor tyrosine kinases (RTKs) implicated in the development and maintenance of tumor vasculature and in the proliferation of some tumor cells. According to George A. Scangos, PhD, president and chief executive officer of Exelixis: "We have worked closely with the FDA to reinitiate the clinical development of XL999 and believe that the approved protocol will enable us to assess both safety and preliminary anti-tumor activity of the compound in patients with NSCLC. In the previous Phase 2 clinical trial of XL999 in NSCLC patien... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=571385 Thu, 26 Apr 2007 11:44:45 +0100 571385 http://www.medworm.com/index.php?rid=568266&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F111826836%2Fusfda_nda_for_xcytrin_injectio.html Pharmacyclics, Inc. (Nasdaq: PCYC) has recently filed a New Drug Application (NDA) to the USFDA for its Xcytrin® (motexafin gadolinium) Injection, seeking approval to market the drug for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases. According to Richard A. Miller, MD, President and CEO of Pharmacyclics: "We are very eager to work with the Agency to complete a thorough and fair review of the extensive data in our NDA. We and our investigators, outside experts and patient advocates believe our data support the efficacy and safety of Xcytrin for the treatment of brain metastases for patients with non-small cell lung cancer and justify a comprehensive review by the Agency. We believe it is in the best interests of patients to do everything we can... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=568266 Wed, 25 Apr 2007 12:25:23 +0100 568266 http://www.medworm.com/index.php?rid=556183&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F110613072%2Fallos_therapeutics_pdx_pralatr.html Allos Therapeutics, Inc. (Nasdaq: ALTH)’s novel antifolate PDX (pralatrexate) for the treatment of patients with peripheral T-cell lymphoma (PTCL) has been granted Orphan Drug Designation by the European Medicines Agency (EMEA). PDX is a novel, small molecule chemotherapeutic agent that inhibits dihydrofolate reductase, or DHFR, a folic acid (folate)-dependent enzyme involved in the building of nucleic acid, or DNA, and other processes. PDX was rationally designed for efficient transport into tumor cells via the reduced folate carrier, or RFC-1, and effective intracellular drug retention. PDX has been awarded the USFDA orphan drug designation in July 2006 for the treatment of patients with T-cell lymphoma and in October 2006 has been granted FDA fast track designation for the treatm... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=556183 Fri, 20 Apr 2007 14:37:01 +0100 556183 http://www.medworm.com/index.php?rid=556186&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F110488168%2Fnew_actonel_dose_for_postmenop.html Actonel® (risedronate sodium tablets) has recently been approved of a new dose (75 mg tablet) by the USFDA which will give patients the option of taking one Actonel 75 mg tablet on two consecutive days, for a total of two tablets monthly, to treat and prevent their postmenopausal osteoporosis. Actonel, a therapy proven to reduce the risk of both vertebral and nonvertebral fractures in postmenopausal women with osteoporosis, will soon be available in this monthly two-day dose option. The said approval was based on the results of an active-controlled, double- blind clinical trial of 1,229 postmenopausal women with osteoporosis aged 50 years or older with a lumbar spine bone mineral density (LS BMD) T-score less than or equal to -2.5 OR a LS BMD T-score less than or equal -2.0 and at leas... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=556186 Fri, 20 Apr 2007 02:31:03 +0100 556186 http://www.medworm.com/index.php?rid=551510&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F110095803%2Fusfda_orphan_drug_designation.html Sirion Therapeutics, Inc.’s anti-viral therapy –ganciclovir – has been awarded Orphan Drug Designation by the USFDA for the treatment of acute herpetic keratitis. Ganciclovir is currently marketed Laboratoires Thea in Europe under the brand name of Virgan®. According to Christine Miller, Sirion's Vice President of Regulatory Affairs: "We are pleased to receive orphan drug designation from the FDA for Ganciclovir. Topical ganciclovir has been available in Europe for the treatment of ocular viral infections for over 10 years. This product has the potential to advance medical treatment of herpes simplex keratitis in the U.S. Herpes simplex keratitis is a leading cause of corneal blindness in the United States." Sirion licensed the U.S. rights to Virgan&re... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=551510 Wed, 18 Apr 2007 17:39:51 +0100 551510 http://www.medworm.com/index.php?rid=551511&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F110073466%2Fgpc_biotechs_nda_for_satraplat.html The USFDA has accepted the submitted New Drug Application (NDA) of GPC Biotech AG (Nasdaq: GPCB) for satraplatin in combination with prednisone for patients with hormone-refractory prostate cancer (HRPC) whose prior chemotherapy has failed. The USFDA has granted Priority Review Status to the said NDA. Priority review designation is intended for those products that address significant unmet medical needs and sets the target date for FDA action at six months from the date of submission. A member of the platinum family of compounds, Satraplatin is an investigational drug that is orally bioavailable and is given as capsules that patients can take home, unlike other platinum-based drugs currently in the market that are administered intravenously. Find more details from the full report. (Source:... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=551511 Wed, 18 Apr 2007 16:16:57 +0100 551511 http://www.medworm.com/index.php?rid=551513&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F110008590%2Fusfda_granted_final_approval_t.html The USFDA has awarded its final approval to Mylan Pharmaceuticals, Inc.(8056336) for its Abbreviated New Drug Application (ANDA) for Glipizide and Metformin Hydrochloride Tablets in 2.5 mg/250 mg, 2.5 mg/500 mg and 5 mg/500 mg strengths. Glipizide and Metformin Hydrochloride Tablets are the generic version of Bristol Myers Squibb's Metaglip™ Tablets.Glipizide and Metformin Hydrochloride Tablets are both oral blood glucose-lowering drugs indicated for the treatment of type 2 diabetes patients whose condition can no longer be controlled by diet alone.Mylan Pharmaceuticals Inc. is a principal subsidiary of Mylan Laboratories Inc. (NYSE: MYL). Source: Mylan Laboratories, Inc. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=551513 Wed, 18 Apr 2007 11:36:54 +0100 551513 http://www.medworm.com/index.php?rid=551514&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F109997186%2Fnew_dose_of_risperdal_consta_f.html The USFDA has recently approved the new 12.5 mg dose of RISPERDAL® CONSTA® [(risperidone) Long-Acting Injection] for the treatment of schizophrenia within specific patient populations (including those with renal and hepatic impairment). Manufactured by Alkermes, Inc. (Nasdaq: ALKS) RISPERDAL® CONSTA® is marketed in the U.S. by Janssen, L.P. and was approved for the treatment of schizophrenia in the U.S. in 2003. The new 12.5 mg dose of RISPERDAL® CONSTA® is expected to be available in the U.S. market by May 1. According to Henry Nasrallah, M.D., Professor of Psychiatry and Neuroscience, and Director of the Schizophrenia Research Program at the University of Cincinnati: "The 12.5 mg dose of RISPERDAL CONSTA will help clinicians to customize treatment for each pa... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=551514 Wed, 18 Apr 2007 10:35:12 +0100 551514 http://www.medworm.com/index.php?rid=551515&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F109985160%2Flupins_novel_formulation_of_su.html The USFDA has approved Lupin Pharmaceuticals, Inc.’s application for Suprax® (Cefixime for oral suspension 200mg/5ml). The new formulation is an extension of Lupin's flagship anti-infective brand Suprax® (Cefixime for oral suspension 100mg/5ml), a higher concentration formulation that will enable parents to administer fewer teaspoons per dose of the antibiotic to their children. (When using the novel dose, parents would need to administer only half the volume of the existing 100mg/5ml suspension.) According to Vinita Gupta, President, Lupin Pharmaceuticals, Inc.: "The approval of our Cefixime for oral suspension 200mg/5ml product allows us to increase our share of the cephalosporin oral suspension pediatric market. This market is currently valued at $625 Million (as ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=551515 Wed, 18 Apr 2007 09:35:50 +0100 551515 http://www.medworm.com/index.php?rid=551516&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F109978095%2Fgsks_altabax_retapamulin_ointm.html The USFDA has recently approved GlaxoSmithKline (NYSE: GSK)’s antibacterial Altabax™ (a pdf file) for the topical treatment of impetigo due to susceptible strains of Staphylococcus aureus or Streptococcus pyogenes - the two most common types of bacteria in this kind of infection. Impetigo is a highly contagious infection of the top layers of the skin and is most common among infants and children ages 2 to 6 years. Children are especially susceptible to infections because their immune systems are still developing. Impetigo spreads easily in schools and child care settings, as well as anywhere groups of people are in close contact.In the past two decades, Altabax™ is the first new class of prescription topical antibacterials (called pleuromutilins) to be approved by the USF... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=551516 Wed, 18 Apr 2007 08:37:06 +0100 551516 http://www.medworm.com/index.php?rid=549985&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F109963973%2Fctis_xyotax_granted_fast_track.html Cell Therapeutics, Inc. (CTI) (Nasdaq: CTICD)’s XYOTAX™ is a novel biologically- enhanced version of one of the most used cancer drugs -Taxol®. Recently, XYOTAX® has been assigned a Fast Track Designation by the USFDA for the treatment of PS2 (poor performance status) women with first-line advanced non-small cell lung cancer (NSCLC), following the company’s submission of a Special Protocol Assessment (SPA) for the design of its phase III trial of XYOTAX for women with advanced NSCLC. The said trial (PGT306) is expected to enrol 300 poor performance status (PS2) women who have advanced stage non- small cell lung cancer (NSCLC) and have not received prior chemotherapy, and will focus exclusively on women with normal estrogen levels. Find more details from the press ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=549985 Wed, 18 Apr 2007 07:26:53 +0100 549985 http://www.medworm.com/index.php?rid=548990&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F109687722%2Fusfda_new_drug_application_nda.html Novalar Pharmaceuticals, Inc.’s NV-101 is a local dental anesthetic reversal agent that has shown efficacy in pivotal studies. Novalar has already applied for NV-101’s marketing approval to the USFDA. According to Donna Janson, President and Chief Executive Officer of Novalar: "The submission of the NV-101 NDA is a key regulatory milestone for Novalar and we will maintain a close interface with the FDA throughout the NDA review process. We will also continue to put in place the necessary marketing and commercialization infrastructure to ensure a successful product launch. In addition, we have intensified our business development efforts to identify and evaluate promising in-licensing opportunities to add to our product pipeline."Phase 3 studies of NV-101 demonstrated ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=548990 Tue, 17 Apr 2007 08:22:44 +0100 548990 http://www.medworm.com/index.php?rid=539253&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F108490863%2Fscheringploughs_pegintron_appr.html The Chinese Food and Drug Administration (SFDA) has approved Schering-Plough Corporation (NYSE: SGP)’s PEGINTRON™ (peginterferon alfa-2b) for the treatment of patients with chronic hepatitis B (the most prevalent infectious disease in China and one of the country's leading causes of death). PEGINTRON™ is administered once weekly at an individualized dose according to a patient's weight and is the only pegylated interferon indicated in China for a 24 week treatment duration in the hepatitis B patient population.In the United States, PEGINTRON™ is indicated for use alone or with ribavirin for the treatment of chronic hepatitis C in patients with compensated liver disease (who have not been previously treated with interferon alpha and who are at least 18 years ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=539253 Thu, 12 Apr 2007 10:44:33 +0100 539253 http://www.medworm.com/index.php?rid=538576&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F108474645%2Fsecond_indication_of_cangenes.html A purified antibody or hyperimmune that is specific for the hepatitis B virus - HepaGam B™ is Cangene's Hepatitis B Immune Globulin Intravenous (Human) which was approved by the USFDA last year for the treatment of exposure to blood containing HBsAg (hepatitis B surface antigen): perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute hepatitis B virus infection. Also, HepaGam B™ and was approved earlier this year by Health Canada for prevention of Hepatitis B recurrence following liver transplantation in adult patients. Now, the USFDA has approved HepaGam B™ for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen ("HBsA... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=538576 Thu, 12 Apr 2007 08:36:58 +0100 538576 http://www.medworm.com/index.php?rid=538577&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F108450176%2Fusfda_approved_abbotts_new_coa.html Abbott’s new coated Niaspan® (niacin extended-release tablets) has recently been approved by the USFDA. Niaspan® - the leading medication in boosting HDL (good) cholesterol - is the only USFDA-approved, once-daily extended-release prescription niacin formulation for the treatment of lipid disorders with can significantly raise HDL cholesterol. Niacin - Niaspan®’s active ingredient - is also indicated for the secondary prevention of heart attacks, to promote regression of coronary atherosclerosis in patients with history of coronary artery disease (in combination with a bile acid binding resin). According to Eugene Sun, M.D., vice president of Global Pharmaceutical Clinical Development, Abbott (NYSE: ABT): "Niaspan has the proven ability to elevate good choleste... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=538577 Thu, 12 Apr 2007 06:42:36 +0100 538577 http://www.medworm.com/index.php?rid=534292&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F107932642%2Fcsl_biotherapies_submitted_bla.html CSL Biotherapies is one of the world’s leading manufacturers of influenza vaccine. The company would like to penetrate the American market and so has recently submitted a Biologics License Application (BLA) to the USFDA, seeking approval of its influenza vaccine for immunization of individuals aged 18 years and above, which when approved will be made into both a single-dose, thimerosal-free, pre-filled syringe and in multi-dose vials. According to Paul Perreault, Executive Vice President of CSL Biotherapies Worldwide Commercial Operations: "Our parent company, CSL Limited, has supplied safe and effective influenza vaccine for more than 40 years. By extending our influenza vaccine franchise into more geographies, including the U.S., our goal is to help address a large and growing... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=534292 Tue, 10 Apr 2007 10:09:58 +0100 534292 http://www.medworm.com/index.php?rid=534293&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F107920559%2Fboston_scientifics_taxus_expre.html The Japanese Ministry of Health, Labor and Welfare (MHLW) has granted marketing approval of Boston Scientific Corporation (NYSE: BSX)’s TAXUS® Express2™ paclitaxel-eluting coronary stent system. According to Jim Tobin, President and Chief Executive Officer of Boston Scientific: "The approval of the TAXUS® Express2™ stent is an important event for the treatment of cardiovascular disease in Japan. We are pleased to provide Japanese physicians with this proven technology, which will help improve the quality of life for so many patients."Boston Scientific will be launching the product into the Japanese market soon. Read the full report. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=534293 Tue, 10 Apr 2007 09:11:10 +0100 534293 http://www.medworm.com/index.php?rid=522063&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F106752081%2Fabbott_submitted_eu_and_us_reg.html Abbott (NYSE: ABT) has submitted a supplemental Biologics License Application (sBLA) to the USFDA and a Type II Variation to the EMEA, seeking marketing approval of HUMIRA® (adalimumab) as a treatment for moderate to severe chronic plaque psoriasis. Psoriasis is a non-contagious, chronic autoimmune disease that causes the body to attack itself and create raised, inflamed, scaly, red skin lesions known as plaques, which may crack and bleed. Psoriasis is more than skin lesions; it is painful and can impact many aspects of a person's life from professional and social activities to personal relationships. People with psoriasis may also suffer from poor self-image and social isolation.Tumor necrosis factor alpha (TNF-a) is a protein that when produced in excess, plays a centra... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=522063 Wed, 04 Apr 2007 07:41:37 +0100 522063 http://www.medworm.com/index.php?rid=522064&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F106752082%2Fcsl_behrings_rhophylac_approve.html An additional indication for CSL Behring (5950871)’s Rhophylac® Rh0(D) (Immune Globulin Intravenous [Human]) has just been granted marketing approval by the USFDA: treatment of immune thrombocytopenic purpura (ITP). Administered intravenously, Rhophylac is indicated to raise platelet counts in Rh0(D)-positive, non-splenectomized adult patients with chronic ITP. Having established efficacy and safety in over 10 years of use for other indications, Rhophylac offers high value pricing to help healthcare practitioners manage costs.Characterized by a low number of platelets (<30 x 10(9)/L), immune thrombocytopenic purpura (ITP) is an autoimmune disease in which the immune system attacks and destroys the body's own platelets – the cells that prevent bleeding in blood vessel... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=522064 Wed, 04 Apr 2007 06:33:22 +0100 522064 http://www.medworm.com/index.php?rid=520591&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F106487501%2Faccelerated_dosing_schedule_of.html The USFDA has just approved GlaxoSmithKline (NYSE: GSK)’s Twinrix® [Hepatitis A Vaccine (Inactivated) and Hepatitis B (Recombinant) Vaccine] for an accelerated dosing schedule: three doses given within three weeks followed by a booster dose at 12 months (0, 7, 21-30 days + booster dose at 12 months). Twinrix® (a pdf file) is the only hepatitis A and hepatitis B combination vaccine available in the United States which was first approved for adults over age 18 years by the FDA in May 2001 on a 0, 1, 6-month dosing schedule. According to travel medicine specialist Bradley A. Connor, M.D., Past President, International Society of Travel Medicine and a principal study investigator: “Twinrix's new accelerated dosing schedule offers an option that could benefit i... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=520591 Wed, 04 Apr 2007 05:22:50 +0100 520591 http://www.medworm.com/index.php?rid=517805&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F106205479%2Ffda_advisory_committee_recomme.html The USFDA’s Office of Cellular, Tissue and Gene Therapies Advisory Committee has recommended the PROVENGE® (sipuleucel-T) for the treatment of patients with asymptomatic, metastatic, androgen-independent (or hormone refractory) prostate cancer. The committee found that there is substantial evidence of efficacy and safety of PROVENGE® (sipuleucel-T) in the abovementioned patient population. According to Mitchell H. Gold, M.D., president and chief executive officer of Dendreon: "Today marks an important milestone for men with advanced prostate cancer. If approved, PROVENGE could become a breakthrough treatment for patients with advanced prostate cancer who currently have few treatment options. We look forward to working closely with the FDA."Once the FDA grants market... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=517805 Tue, 03 Apr 2007 05:09:34 +0100 517805 http://www.medworm.com/index.php?rid=517807&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F106184764%2Fgsk_submitted_eu_regulatory_ap.html GlaxoSmithKline (NYSE: GSK) has submitted regulatory approval to the European Medicines Agency (EMEA) under Article 58 for the combination vaccine candidate Globorix™ (diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Neisseria meningitides serogroups A and C). The conjugate meningococcal vaccine has demonstrated a good safety profile and immunogenicity (in clinical trials including countries in Africa and Asia) against meningococcal meningitis caused by Neisseria meningitidis serogroups A and C in addition to five other major childhood diseases. According to Jean Stephenne, President of GlaxoSmithKline Biologicals: "GSK's long-standing commitment to the developing world is reflected in the development of Globorix™, a vaccine designed spe... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=517807 Tue, 03 Apr 2007 03:09:04 +0100 517807 http://www.medworm.com/index.php?rid=516587&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F106174111%2Fnovartis_heeds_fda_request_to.html Zelnorm® (tegaserod maleate) is a product of Novartis (VTX: NOVN) for the treatment for irritable bowel syndrome (IBS) with constipation and chronic constipation. Zelnorm® received FDA approval for the short-term treatment of women with IBS with constipation in the US on July 24, 2002. Zelnorm® also received FDA approval for the treatment of men and women less than 65 years of age with chronic idiopathic constipation in the US on August 20, 2004.Recently, Novartis has suspended the sales and marketing of Zelnorm® in the United States in compliance to a request from the USFDA following significant data that associated intake of Zelnorm® to incidence of cardiovascular ischemic events, including myocardial infarction, stroke, and unstable angina pectoris. According to Step... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=516587 Tue, 03 Apr 2007 02:02:16 +0100 516587 http://www.medworm.com/index.php?rid=515920&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F105921151%2Fgsk_submitted_bla_to_usfda_for.html GlaxoSmithKline (NYSE:GSK) has recently submitted a Biologics License Application (BLA) for CERVARIX® (human papillomavirus vaccine, AS04 adjuvant-adsorbed) to the USFDA. CERVARIX® is GSK’s candidate vaccine for cervical cancer, which when approved will be indicated for the prevention of cervical cancer and precancerous lesions associated with the most common cancer-causing human papillomavirus (HPV) types. The GSK cervical cancer candidate vaccine is formulated with a proprietary adjuvant system called AS04, containing aluminum hydroxide and monophosphoryl lipid A (MPL®). Published data have shown that the GSK cervical cancer candidate vaccine formulated with AS04 provides a stronger and longer lasting immune response compared to the same GSK vaccine composition formulat... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=515920 Mon, 02 Apr 2007 04:02:27 +0100 515920 http://www.medworm.com/index.php?rid=511485&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F105273595%2Fnuvelos_rnapc2_received_usfda.html The USFDA has granted two separate fast track designations to Nuvelo, Inc. (Nasdaq: NUVO)’s product candidate rNAPc2: for first-line treatment of metastatic colorectal cancer (mCRC) to improve progression-free survival and overall survival when added to Avastin®-containing 5-flurourocil (5-FU)-based chemotherapy regimensfor second-line treatment of mCRC to improve progression-free survival and overall survival when added to 5-FU-based chemotherapy regimensA USFDA Fast track designation is reserved for new drugs that demonstrate the potential to address an unmet medical need and are intended for the treatment of a serious or life-threatening condition. Recombinant nematode anticoagulant protein c2 (rNAPc2), a recombinant protein that interferes with the tissue factor/factor VIIa/f... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=511485 Thu, 29 Mar 2007 09:17:45 +0100 511485 http://www.medworm.com/index.php?rid=508524&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F105100180%2Fremicade_recommended_for_appro.html Co-developed by Centocor, Inc. and Schering-Plough Corporation (NYSE: SGP), REMICADE® (infliximab) was first approved in the U.S. ( by the USFDA) in 1998 as treatment U.S. for adult Crohn's disease (CD) and later, in 2005, for adult ulcerative colitis. REMICADE® is a monoclonal antibody that specifically targets TNF-alpha, which has been shown to play a role in Crohn's disease (CD), rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), ulcerative colitis (UC) and psoriasis (PsO). REMICADE® is the global market leader among anti-tumor necrosis factor alpha (TNF-alpha) therapies and the only agent approved for the treatment of both RA and CD in North America, the EU and Japan.The USFDA approval of REMICADE® in May 2006 for pediatric patien... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=508524 Thu, 29 Mar 2007 08:12:58 +0100 508524 http://www.medworm.com/index.php?rid=506173&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F104842897%2Ffirst_therapeutic_vaccine_for.html The U.S. Department of Agriculture has conditionally approved a novel therapeutic vaccine for the treatment of canine melanoma – a common but deadly form of cancer in dogs. Canine melanoma is an aggressive form of cancer that typically appears in a dog's mouth, but also may appear in the nail bed, foot pad or other areas. Dogs with melanomas that have gone beyond initial stages typically have a lifespan of one to five months with conventional therapies. To date, the most common treatments for this form of cancer have been radiation and surgery.The melanoma vaccine was developed through a partnership between Merial (11789369), Memorial Sloan-Kettering Cancer Center (MSKCC) and The Animal Medical Center (AMC) of New York. The vaccine will initially be available for use by specialis... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=506173 Wed, 28 Mar 2007 04:48:15 +0100 506173 http://www.medworm.com/index.php?rid=502964&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F104654103%2Femea_recommends_oral_cancer_dr.html The European Medicines Agency (EMEA) has granted a positive opinion on Celgene Corporation (Nasdaq: CELG)’s novel oral cancer drug REVLIMID® (lenalidomide) for use in combination with dexamethasone as a treatment for patients with multiple myeloma who have received at least one prior therapy. EMEA's Committee for Medicinal Products for Human Use (CHMP) has already forwarded its recommendation of approval for the said drug to the European Commission – the body who issues the final marketing approval in 2-3 months time. Already approved by the USFDA as a treatment in combination with dexamethasone for patients previously treated with multiple myeloma, REVLIMID® has obtained Orphan Drug designation in the EU, US and Australia. Find more details from the full report. (S... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=502964 Tue, 27 Mar 2007 09:12:01 +0100 502964 http://www.medworm.com/index.php?rid=500833&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F104388887%2Fminrads_sevoflurane_approved_i.html MINRAD International, Inc.’s exclusive distribution partner in Japan – Merck Seiyaku – has received marketing approval from Japanese Ministry of Health for Sevoflurane. An interventional pain management company, MINRAD International, Inc. (AMEX: BUF) has real time image guidance and anesthesia and analgesia product lines. Sevoflurane is an inhaled general anesthetic. Read the full report.[photo credit: Baxter Sevo] (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=500833 Mon, 26 Mar 2007 03:40:24 +0100 500833 http://www.medworm.com/index.php?rid=500834&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F104380317%2Fcti_filed_usfda_spa_for_phase.html Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC) has recently filed a Special Protocol Assessment (SPA) to the US FDA for the design of a phase III trial of combination therapy for women with advanced lung cancer. The said trial, known as PGT307, will focus on women with normal estrogen levels, and will evaluate XYOTAX™ (paclitaxel poliglumex) in combination with carboplatin versus paclitaxel/carboplatin in female NSCLC patients with performance status of 0, 1 or 2. The trial is targeting to enrol 450 patients; the interim analysis is planned in the first half of 2008. According to James A. Bianco, M.D., President and CEO of CTI: "The basis for this trial is the survival benefit we saw among pre-menopausal women in our STELLAR 3 trial, where the XYOTAX/carboplatin combinat... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=500834 Mon, 26 Mar 2007 02:30:54 +0100 500834 http://www.medworm.com/index.php?rid=498793&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F104045983%2Fnoxafil_posaconazole_is_recomm.html NOXAFIL® (posaconazole) Oral Suspension, an antifungal agent by Schering-Plough Corporation (NYSE: SGP) has received a category 1 recommendation (1) (highest rating) for preventing certain invasive fungal infections (IFIs) in high-risk cancer patients and a category 2B recommendation (2) for preventing IFIs in neutropenic cancer patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Such recommendations are included in the most recent National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Prevention and Treatment of Infections in Patients with Cancer. NCCN is an alliance of 20 leading U.S. cancer centers and the NCCN Clinical Practice Guidelines in Oncology are the recognized standard for clinical practice in the oncology commu... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=498793 Sat, 24 Mar 2007 08:30:29 +0100 498793 http://www.medworm.com/index.php?rid=486691&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F102844957%2Fexelixis_submitted_ind_for_can.html Exelixis, Inc. (Nasdaq: EXEL) has recently submitted an investigational new drug (IND) application to the USFDA for its candidate anticancer compound XL147. XL147 is a novel, orally available small molecule that selectively inhibits the activity of phosphoinositide-3 kinase (PI3K). In human tumors, activation of PI3K is frequent – thereby promoting tumor cell growth, survival, and resistance to chemotherapy and radiotherapy. According to Gisela M. Schwab, MD, senior vice president and chief medical officer at Exelixis: "A growing body of data indicates that inappropriate activation of the PI3K signaling pathway is a common feature of human tumors and may result from dysregulation at multiple points along the signaling cascade. We are therefore evaluating multiple compounds that ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=486691 Mon, 19 Mar 2007 04:05:29 +0100 486691 http://www.medworm.com/index.php?rid=486695&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F102697473%2Falexion_pharmas_soliris_first.html The USFDA has recently approved Soliris™ (eculizumab) for the treatment of all patients with paroxysmal nocturnal hemoglobinuria (PNH). A product of Alexion Pharmaceuticals, Inc., (Nasdaq: ALXN), Soliris™ is the first therapy ever approved for PNH and is indicated for the treatment of patients with PNH to reduce hemolysis. PNH or paroxysmal nocturnal hemoglobinuria is a rare, disabling and life-threatening blood disorder defined by chronic red blood cell destruction, or hemolysis – causing one or more of the following symptoms in patients with PNH: severe anemia, disabling fatigue, recurrent pain, shortness of breath, pulmonary hypertension, intermittent episodes of dark colored urine (hemoglobinuria), kidney disease, impaired quality of life and blood clots (thromboses).... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=486695 Mon, 19 Mar 2007 02:53:59 +0100 486695 http://www.medworm.com/index.php?rid=486703&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F102313924%2Fspa_for_phase_iii_clinical_tri.html A Special Protocol Assessment (SPA) has been submitted by Cell Therapeutics, Inc. (Nasdaq: CTIC) to the U.S. Food and Drug Administration (FDA) for the design of its phase III trial of pixantrone for patients with indolent non- Hodgkin's lymphoma (NHL). The said trial, expecting to enroll 300 patients, will evaluate the complete remission rates and time to disease progression of the combination regimen of fludarabine, pixantrone and rituximab (FP-R) compared to the combination of fludarabine and rituximab (F-R) in the treatment of patients who have failed up to five prior treatments for relapsed or refractory indolent NHL. Pixantrone was developed to improve the activity and safety of the anthracycline family of anti-cancer agents – which has been associated to cardiotoxicities. ... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=486703 Sat, 17 Mar 2007 02:30:44 +0100 486703 http://www.medworm.com/index.php?rid=486708&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F102134315%2Fadvanced_life_sciences_cethrom.html The USFDA has granted an Orphan Drug Designation to cethromycin for the prophylactic treatment of patients exposed to inhalation anthrax. Cethromycin - a second generation ketolide antibiotic undergoing Phase III clinical trial for the treatment of respiratory tract infections – is Advanced Life Sciences' most advanced product candidate. Proven for the treatment of mild-to-moderate community acquired pneumonia (CAP), cethromycin is currently being tested in non-human primates to determine its potential efficacy for the prophylactic treatment of patients exposed to inhalation anthrax. According to Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences (Nasdaq: ADLS), commenting on the notice of designation: "We are very pleased to receive thi... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=486708 Fri, 16 Mar 2007 11:26:20 +0100 486708 http://www.medworm.com/index.php?rid=486711&cid=t_221059_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F102134316%2Fusfda_accepted_adams_respirato.html The USFDA has recently accepted the New Drug Application (NDA) submitted by Adams Respiratory Therapeutics, Inc. (Nasdaq: ARXT) for 600 mg and 1200 mg oral solid extended release guaifenesin combination products for the prescription treatment of cough. The said NDA is now under formal review of the USFDA – representing the first prescription product in Adams' current portfolio of respiratory products. Adams Respiratory Therapeutics, Inc. is a specialty pharmaceutical company focused on the late-stage development, commercialization and marketing of over-the-counter and prescription pharmaceuticals for the treatment of respiratory disorders. Read the full press release. (Source: PharmaGazette) PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=486711 Fri, 16 Mar 2007 10:19:56 +0100 486711