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Dendreon Receives FDA Acknowledgement Of Complete Responseemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Dendreon Corporation (Nasdaq: DNDN) announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of May 1, 2010, by which time it will respond to Dendreon's amended BLA. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 21, 2009 Category: Pharmaceuticals Tags: Prostate / Prostate Cancer Source Type: news

Lawmakers Call For Inquiry Into Pharmaceutical Company Price Hikesemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Reuters: "Congressional Democrats are seeking government investigations into recent price increases of brand-name prescription drugs, as Congress finalizes an overhaul of the healthcare system. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 20, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Daschle Still Making Voice Heard On Health Careemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
The Hill reports that former Senate Majority Leader Tom Daschle helped Obama Administration officials strategize to win health care reform votes from Senators on Capitol Hill Wednesday. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 20, 2009 Category: Pharmaceuticals Tags: Health Insurance / Medical Insurance Source Type: news

Adamas Pharmaceuticals Expands Clinical Study For Triple-Combination Antiviral Drug Therapy In Immune Compromised Patientsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Adamas Pharmaceuticals, Inc., a privately held company, announced that it has expanded its Phase 2 clinical study of a proprietary investigational triple-combination antiviral drug therapy for influenza to include centers in the United States, Canada and Europe. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 20, 2009 Category: Pharmaceuticals Tags: Swine Flu Source Type: news

BIO Announces Presidents Bill Clinton And George W. Bush To Provide Keynote At 2010 BIO International Conventionemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
The Biotechnology Industry Organization (BIO) announces that Presidents Bill Clinton and George W. Bush, the 42nd and 43rd Presidents of the United States, will appear together for a moderated discussion at the 2010 BIO International Convention, which will be held May 3-6 in Chicago, Ill. at McCormick Place. Presidents Clinton and Bush, who served in the White House for 16 years, will discuss a wide variety of issues relating to both domestic and foreign policy. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 19, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Generic And Brand-Name Drug Makers Face Offemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
"Teva Pharmaceuticals, a leading manufacturer of generic drugs, has been aggressively lobbying Congress to scrap provisions in the health care bills it claims would shut it out of the biologic drug market for too long," Roll Call reports. Lobbyists for the biologics makers have charged, however, that Teva is hypocritical because it is fighting to restrict generic production of its own brand-name product. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 19, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Clinical Budgeting And Contracting Excellence Strategies That Empower Investigators And Support Patient Enrollment 7-8 Dec, 2009, Princeton New Jerseyemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Alarming trends captured in clinical study metrics show the glaring discrepancy between the miniscule number of sites that are able to enroll the amount of patients study sponsors are requesting and the amount of sites that cannot. This enrollment inability leads to trial stoppages, lost revenue and most importantly the delay of new treatments used to combat diseases that are available for the population. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 19, 2009 Category: Pharmaceuticals Tags: Conferences Source Type: news

CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Franciscoemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 19, 2009 Category: Pharmaceuticals Tags: Pain / Anesthetics Source Type: news

Zydena Is Efficacious In Once Daily Dosing For Erectile Dysfunction/Positive BPH Resultsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Dong-A Pharmaceutical Co., Ltd. and Dong-A PharmTech, Co. Ltd. announced that it has completed a 240 patient once-a-day dosing clinical study of udenafil, its new long acting phosphodiesterase type 5 (PDE-5) inhibitor for erectile dysfunction (ED). The multi-center study conducted in Korea was a randomized, double-blind, placebo-controlled study, designed to investigate the efficacy and safety of udenafil in patients with ED. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 19, 2009 Category: Pharmaceuticals Tags: Erectile Dysfunction / Premature Ejaculation Source Type: news

White House Deal With Drug Makers May Be Unravelingemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
"Congressional Democrats' intensifying efforts to pay for their healthcare overhaul and provide more relief for consumers are threatening to unravel a White House deal with the pharmaceutical industry and turn one of Washington's most powerful lobbies against the legislation," the Los Angeles Times reports. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 18, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

NeurogesX To Hold Conference Call To Discuss FDA Approval Of Qutenza(TM) (capsaicin) 8% Patch For Treatment Of Postherpetic Neuralgia (PHN)email this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
NeurogesX, Inc. (Nasdaq: NGSX) announces that it will hold a conference call at 8:30a.m. ET (5:30a.m. PT) to discuss the U.S. Food and Drug Administration (FDA) approval of Qutenza(TM) (capsaicin) 8% patch, the first and only product containing prescription strength capsaicin, for the management of neuropathic pain due to postherpetic neuralgia (PHN), the nerve pain which can follow shingles. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 18, 2009 Category: Pharmaceuticals Tags: Pain / Anesthetics Source Type: news

InterMune Announces Modification To On-Going Phase 2b Study Of ITMN-191 In Patients With Chronic HCV Infectionemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
InterMune, Inc. (Nasdaq: ITMN) announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified. The Phase 2b study has four dosage cohorts: SOC; 300mg q8h plus SOC; 600mg q12h plus SOC and 900mg q12h plus SOC. To date, approximately 175 patients have been enrolled in the study. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 18, 2009 Category: Pharmaceuticals Tags: Liver Disease / Hepatitis Source Type: news

Drug Makers Hike Prices, Lobby Hard As Reform Efforts Progressemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Drug makers are bracing for reform by raising their prices - by 9 percent in the last year, perhaps the fastest rate since 1992, The New York Times reports. This happened "even as drug makers promise to support Washington's health care overhaul by shaving $8 billion a year off the nation's drug costs after the legislation takes effect. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 17, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

XTEN Data From Amunix And Versartis Featured In Nature Biotechnology As A Novel Platform For Increasing Serum Half-Life Of Protein Therapeuticsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Amunix, Inc. and Versartis, Inc. announced today that the scientific journal Nature Biotechnology has published a comprehensive paper entitled "A recombinant polypeptide extends the in vivo half-life of peptides and proteins in a tunable manner." The paper (http://dx.doi.org/10.1038/nbt. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 17, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Hollis-Eden Presents New Interim Data From Prostate Cancer Phase I/II Clinical Studies Of Apoptone (HE3235) At AACR Molecular Targets Conferenceemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Hollis-Eden Pharmaceuticals, Inc. (Nasdaq: HEPH), reported preliminary results of its ongoing Phase I/II clinical trial with Apoptone® (HE3235) for hormone-resistant prostate cancer (also called castrate-resistant prostate cancer or CRPC). (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 17, 2009 Category: Pharmaceuticals Tags: Prostate / Prostate Cancer Source Type: news

Today's Opinions And Editorialsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Half Done On Health Reform The Washington Post Unless you find more realistic ways of paying for the promises included in the bill, you are simply setting up the public for more frustration -- and yourselves for a political backlash (David Broder, 11/13). (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 16, 2009 Category: Pharmaceuticals Tags: Health Insurance / Medical Insurance Source Type: news

Pharma's Fourth Hurdle - Market Accessemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Getting regulatory agency approval for a new drug was once the end goal of pharmaceutical drug development, but in today's healthcare environment where governments increasingly determine price and the availability of drugs to patients through formulary designation, market access has become the "fourth hurdle" in successfully bringing a drug to market. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 13, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Researchers Make Recommendations For Minimizing Harm And Maximizing Benefits Of Drug Adsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
While the debate over prescription drug advertising persists, a new study released online in the American Journal of Public Health offers guidelines for improving drug ads in order to minimize potential harm and maximize benefits. The study reveals that while there are some benefits from prescription drug direct-to-consumer advertising (DTCA), there are significant risks that are magnified by the prominence of DTCA. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 13, 2009 Category: Pharmaceuticals Tags: Pharmacy / Pharmacist Source Type: news

Pioneering New Methods Of Drug Manufactureemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Engineers at the University of Leeds have developed a simple technology which can be used in existing chemical reactors to ensure "right first time" drug crystal formation. Ensuring drug crystals are formed correctly is crucial to their efficacy and the efficiency of pharmaceutical manufacturers' operations. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 12, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Pandemic 2009 Influenza Update: Pandemrix™ Data On Co Administration With Annual Seasonal Influenza Vaccine (Fluarix®)email this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
GlaxoSmithKline (GSK) announced the results from the clinical trial assessing Pandemrix™, GSK's adjuvanted H1N1 pandemic influenza vaccine, administered at the same time as the annual seasonal influenza vaccine, Fluarix ®. The trial showed that co-administration of one dose of both vaccines in separate arms, induced a strong response in adults for both the H1N1 pandemic vaccine as well as the seasonal vaccine. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 12, 2009 Category: Pharmaceuticals Tags: Swine Flu Source Type: news

Viron To Present Data From Phase II Trial At American Heart Association Conferenceemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Viron Therapeutics Inc., a biopharmaceutical company pioneering the development of viral protein therapeutics, announced that the Company's research collaborator, Dr. Jean-Claude Tardif, Director of the Research Center at the Montreal Heart Institute, will present data from a Phase IIa clinical trial evaluating VT-111 at the American Heart Association (AHA) Scientific Sessions 2009 conference. The conference will take place in Orlando, Florida from November 14 to 18, 2009. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 12, 2009 Category: Pharmaceuticals Tags: Heart Disease Source Type: news

Teva Receives Final Approval For Generic Prevacid(R) Delayed-Release Capsulesemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Tap Pharmaceutical's proton pump inhibitor Prevacid® (lansoprazole) Delayed-Release Capsules, 15 mg and 30 mg. Customers will begin receiving product on November 11, 2009. Annual sales of Prevacid® Delayed-Release Capsules were approximately $2. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 12, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Teva Receives Favorable Court Decision Regarding Generic Prevacid(R) SoluTabemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. District Court for the District of Delaware has issued a decision in its litigation over the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Takeda Pharmaceuticals North America, Inc.'s Prevacid® (Lansoprazole) SoluTab. The Court found that Teva's generic lansoprazole orally disintegrating tablets do not infringe U.S. Patent No. 5,464,632. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 11, 2009 Category: Pharmaceuticals Tags: Litigation / Medical Malpractice Source Type: news

NexBio(R) Presents Data Showing Anti-Asthma Activity Of DAS181 (Fludase(R)) At ACAAI 2009email this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
NexBio, Inc. announced the presentation of new data at the 2009 annual American College of Allergy, Asthma, and Immunology in Miami, Florida. The presentation was entitled "DAS181 (Fludase®), a Sialidase, Decreases Airway Resistance and Has Potent Anti-inflammatory Effects in Animal Models of Asthma". (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 10, 2009 Category: Pharmaceuticals Tags: Respiratory / Asthma Source Type: news

1st Symposium On Scale Up Of Oral Solid Dosage Formsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
GEA Pharma Systems joined forces with Evonik Industries last month to present their first ever joint symposium on 'Scale up of Oral Solid Dosage Forms'. The event was held at the Hotel Bad Bubendorf in Switzerland and co-hosted by Dr. Harald Stahl of GEA Pharma Systems and Dr. Bridgitte Skalsky of Evonik Röhm GmbH. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 10, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Medtronic Receives President's "E" Award In Recognition Of Its Support Of U.S. Exportsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Recognizing its significant contributions to increasing U.S. exports, Medtronic, Inc., (NYSE: MDT) received President Barack Obama's "E" Award on Thursday, Nov. 5. The ceremony, held in the U.S. Department of Commerce, was part of the District Export Council Conference in Washington D.C. The award recognized Medtronic and other individuals and companies for their efforts in promoting and increasing U.S. exports. "We are pleased to receive this recognition. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 8, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Lundbeck Starts Clinical Phase IIa With Lu AA24493 (cEPO) In Friedreich's Ataxia In A Study Also Assessing Efficacy Via Biomarkersemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
H. Lundbeck A/S strengthens its pipeline of pharmaceuticals in clinical development by initiating phase IIa clinical studies with the innovative project Lu AA24493 in order to evaluate safety and tolerability and to explore theoretical efficacy parameters of the drug in humans. Lundbeck expects to enrol 35-40 people suffering from Friedreich's ataxia in this study. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 7, 2009 Category: Pharmaceuticals Tags: Neurology / Neuroscience Source Type: news

DNA Molecules In Moss Open Door To New Biotechnologyemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Plasmids, which are DNA molecules capable of independent replication in cells, have played an important role in gene technology. Researchers from Uppsala University in Sweden have now demonstrated that plasmid-based methods, which had been limited to single-cell organisms such as bacteria and yeasts, can be extended to mosses, opening the door to applications of a number of powerful techniques in plant research. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 7, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Stimulus Grant To Help MSU Team Improve Drug Development From Plantsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Scientists at Michigan State University are receiving nearly $3 million from the National Institutes of Health to uncover how several popular plants make medicinal compounds. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 7, 2009 Category: Pharmaceuticals Tags: Biology / Biochemistry Source Type: news

DOJ Investigates Alleged Fraud By Drugmakers; Sanctions On WellCare Liftedemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
News outlets focus on alleged fraud in the drug and insurance industries. "A $112 million settlement involving alleged drug kickbacks that the Justice Dept. announced with the nation's largest nursing home pharmacy and a generic drug manufacturer on Nov. 3 is part of a wide-ranging investigation of suspected Medicaid fraud by the pharmaceutical industry," (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 6, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Wall Street Journal Examines Big Pharma's 'Growing Interest' In Emerging-Market Vaccine Development, Productionemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
The Wall Street Journal examines "big pharma's growing interest in a corner of healthcare - emerging-market inoculations," in light of a recent move by Novartis to purchase an 85 percent stake in the Chinese vaccine maker Zhejiang Tianyuan Bio-Pharmaceutical Co. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 6, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Amgen Announces Overall Survival Results For Vectibix(R) In First-Line Metastatic Colorectal Canceremail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Amgen (Nasdaq: AMGN) announced that the Phase 3 PRIME "203" trial evaluating Vectibix® (panitumumab) administered in combination with FOLFOX (an oxaliplatin-based chemotherapy) as a first-line treatment of metastatic colorectal cancer (mCRC) failed to meet a secondary endpoint of overall survival. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 6, 2009 Category: Pharmaceuticals Tags: Colorectal Cancer Source Type: news

Helix BioPharma Corp. Completes Enrollment In Its Phase II Trial Of Topical Interferon Alpha-2b In Patients With Ano-Genital Wartsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Helix BioPharma Corp. (TSX, FSE: "HBP" / OTCQX: HXBPF) announced that its Phase II trial of Topical Interferon Alpha-2b for the treatment of ano-genital warts (AGW) has completed patient enrollment, with the required 120th patient randomized to enter the trial. The double-blind and placebo-controlled Phase II trial is underway at multiple centers in Germany and Sweden. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 6, 2009 Category: Pharmaceuticals Tags: Cervical Cancer / HPV Vaccine Source Type: news

The Creation Of A New Niche Specialty Pharmaceutical Company Focused On Rare Diseases - With Strong Cash Flow Generation And Growth Potentialemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Biovitrum and Swedish Orphan will be combined forming Swedish Orphan Biovitrum with pro forma revenues 2009 of approximately SEK 2 billion and an EBITDA margin of 15 percent. Biovitrum will pay an upfront consideration of SEK 3.5 billion (on a cash and debt free basis), to be financed by a fully guaranteed rights issue, an issue in kind and bank financing. The Transaction will be instantly accretive to earnings per share for Biovitrum's shareholders. Shared mission. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 5, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Man Sentenced For Sale And Supply Of Controlled And Counterfeit Drugsemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
A 41-year-old man, Mr Harish Gami, received an eight month prison sentence suspended for two years at Aylesbury Crown Court today for the illicit sale and supply of controlled drugs as well as counterfeit and unlicensed medicines. The Medicines and Healthcare products Regulatory Agency (MHRA) discovered more than 86,000 Valium tablets and a further 11,500 medicinal products in an undercover investigation into Gami's illegal online dealing. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 5, 2009 Category: Pharmaceuticals Tags: Litigation / Medical Malpractice Source Type: news

FDA Unveils Safe Use Initiative That Targets Preventable Harm From Medication Useemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
The U.S. Food and Drug Administration announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use. "Too many people suffer unnecessary injuries from avoidable medication misuse, errors and other problems. The FDA is launching the Safe Use Initiative to develop targeted solutions for reducing these injuries," said FDA Commissioner Margaret A. Hamburg, M.D. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 5, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

ViraCor-IBT Laboratories To Present At The American College Of Allergy, Asthma And Immunology's Annual Meetingemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Scientists from ViraCor-IBT Laboratories have been selected to provide four oral presentations and one poster presentation at this year's American College of Allergy, Asthma and Immunology's Annual Scientific Meeting in Miami, Florida. Michelle Altrich, PhD, HCLD (ABB), and Michael Ling, PhD, will present data on a wide range of topics including Filaggrin, Pneumococcal Antibody Avidity, Chronic Urticaria, Drug Hypersensitivity Reactions and T-Cell Excision Circles. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 5, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Drug Company-sponsored Events For Health Professionals Fail To Disclose Financial Tiesemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Australian reporting standards for disclosing the ties between pharmaceutical companies and health professionals are not comprehensive enough, according to an analysis in this weeks PLoS Medicine. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - November 5, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Transcept Pharmaceuticals Receives Complete Response Letter From FDA On Intermezzo(R) New Drug Applicationemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Transcept Pharmaceuticals (Nasdaq: TSPT) announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). The NDA, submitted by Transcept in September 2008, seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - October 30, 2009 Category: Pharmaceuticals Tags: Sleep / Sleep Disorders / Insomnia Source Type: news

Sinovac Receives Certificate Of Approval To Distribute PANFLU.1 (H1N1) In Mexicoemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Sinovac Biotech Ltd. (NYSE Amex: SVA), a leading developer and provider of vaccines in China, today announced that it has received a Certificate of Approval from the Secretaria de Salud to distribute PANFLU.1, its H1N1 pandemic influenza (swine flu) vaccine, in Mexico. The certificate is valid through October 13, 2014. Laboratorios Imperiales S.A. de C.V. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - October 23, 2009 Category: Pharmaceuticals Tags: Swine Flu Source Type: news

EnWave Announces Successful Test Results For Antibodies Using FreezeREV Dehydration Technologyemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
EnWave Corporation (TSX VENTURE:ENW) ("EnWave" or "the Company") today announced that it has successfully dried three different antibodies in the Company's prototype freezeREV vial dehydration technology. Results from this study showed no detectable visual difference between freezeREV-dried and freeze dried samples when examined with the SDS-PAGE electrophoresis method. Additionally, the indication of the molecular weight was similar between the two dried samples and liquid antibodies. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - September 25, 2009 Category: Pharmaceuticals Tags: Biology / Biochemistry Source Type: news

DrugScope Responds To 'Legal Highs' Banemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Responding to today's announcement that GBL, 'Spice; and BZP will be made illegal under the Misuse of Drugs Act, Martin Barnes, chief executive of the drug information charity DrugScope said: "DrugScope supports the Government's decision to follow the advice of the ACMD and make GBL and BZP Class C substances. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - August 28, 2009 Category: Pharmaceuticals Tags: Pharma Industry / Biotech Industry Source Type: news

Essentialis To Submit SPA For Hypertriglyceridemiaemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Essentialis, Inc., a clinical stage pharmaceutical company, announced today its intention to file a Special Protocol Assessment (SPA) with the FDA for the pivotal study to support the NDA filing on its lead drug, DCCR, for the treatment of very high triglycerides. The proposed study would include 280 randomized subjects with the primary efficacy endpoint assessed at 12 weeks. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - August 13, 2009 Category: Pharmaceuticals Tags: Cholesterol Source Type: news

Palatin Technologies, Inc. Reports Positive Bremelanotide Study; Improved Safety Profile With Subcutaneous Administrationemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Palatin Technologies, Inc. (NYSE Amex: PTN) announced the completion of a Phase 1 clinical trial of subcutaneously administered bremelanotide, its melanocortin agonist drug candidate for treatment of male erectile dysfunction (ED) and female sexual dysfunction (FSD). The results demonstrate that with subcutaneous administration consistent therapeutic blood plasma levels can be obtained without blood pressure side effects. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - August 13, 2009 Category: Pharmaceuticals Tags: Erectile Dysfunction / Premature Ejaculation Source Type: news

Accera Announces Peer-Reviewed Publication Of The Results Of Its 90-Day Clinical Study Of AC-1202 (Axona(TM) ) In Mild To Moderate Alzheimer's Diseaseemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system (CNS) disorders, announced publication of a scientific paper in the peer-reviewed journal Nutrition & Metabolism. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - August 13, 2009 Category: Pharmaceuticals Tags: Alzheimer's / Dementia Source Type: news

FDA Approves Sculptra(R)Aesthetic, A Facial Injectable For Correction Of Nasolabial Folds And Other Facial Wrinklesemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Sanofi-aventis U.S. announced that the U.S. Food and Drug Administration (FDA) approved Sculptra(R)Aesthetic (injectable poly-L-lactic acid) for the correction of shallow to deep nasolabial fold (smile lines) contour deficiencies and other facial wrinkles which are treated with the appropriate injection technique in healthy patients. Sculptra(R)Aesthetic works gradually to offer natural-looking results that can last up to two years. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - July 30, 2009 Category: Pharmaceuticals Tags: Dermatology Source Type: news

Human Genome Sciences And GlaxoSmithKline Announce Positive Phase 3 Study Results For BENLYSTA(TM) In Systemic Lupus Erythematosusemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) announced that BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - July 21, 2009 Category: Pharmaceuticals Tags: Lupus Source Type: news

New HIV Study Shows That Large Numbers Of Women And People Of Color Can Be Successfully Enrolled In U.S. HIV Clinical Studiesemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Data from a historic HIV study demonstrate that it is possible to recruit large numbers of women, African Americans and Latinos into U.S.-based HIV-1 treatment studies. The study, known as GRACE, is the largest study to date in treatment-experienced adult women with HIV-1 to examine gender and race differences in response to an HIV-1 therapy -- PREZISTA(R) (darunavir) coadministered with ritonavir as part of combination therapy. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - July 21, 2009 Category: Pharmaceuticals Tags: HIV / AIDS Source Type: news

96-Week Safety And Efficacy Findings Presented For INTELENCE(TM) (etravirine) As Part Of HIV Combination Therapyemail this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
Ninety-six week pooled results from two Phase 3 studies (DUET-1 and DUET-2) showed that significantly more treatment-experienced HIV-1-infected adults with non-nucleoside reverse transcriptase inhibitor (NNRTI) and protease inhibitor (PI) resistance had an undetectable viral load ( (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - July 21, 2009 Category: Pharmaceuticals Tags: HIV / AIDS Source Type: news

US Oncology Research Network Participates In Phase III Follow-up Study To BiPar's Investigational Cancer Drug BSI-201email this articleEmail this article to a colleague. save this article to My ClippingsSave this article to My Clippings. discuss this articleDiscuss or comment on this article.
US Oncology, Inc. today announced that US Oncology Research will participate in the BiPar Sciences' Phase III, Multi-center, Open-Label, Randomized Trial of Gemcitabine/Carboplatin (G/C), with or without BSI-201, in patients with Estrogen Receptor (ER), Progesterone Receptor (PR), and HER2-negative metastatic breast cancer. Joyce O'Shaughnessy, M.D. (Source: Pharma Industry News From Medical News Today)
Source: Pharma Industry News From Medical News Today - July 21, 2009 Category: Pharmaceuticals Tags: Breast Cancer Source Type: news