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GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addictionEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
- Upfront and potential consideration of over $500 million (Source: GSK news)
Source: GSK news - November 16, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic 2009 Influenza Update: US FDA approves GSK’s pandemic H1N1 vaccineEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today announced that the US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for its unadjuvanted influenza A (H1N1) pandemic vaccine. (Source: GSK news)
Source: GSK news - November 10, 2009 Category: Pharmaceuticals Source Type: organizations

GSK signs agreement with the WHO to donate 50 million doses of pandemic H1N1 vaccine for distribution to developing countriesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today announced that it has signed an agreement with the World Health Organization (WHO) to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to WHO for distribution to developing countries most in need. (Source: GSK news)
Source: GSK news - November 10, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline and XenoPort announce extension of GSK1838262 (XP13512) FDA review date to 9 February, 2010Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (NYSE: GSK) and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. (Source: GSK news)
Source: GSK news - November 9, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic 2009 Influenza Update: Pandemrix™ data on co-administration with annual seasonal influenza vaccine (Fluarix®)sEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today 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 ®. (Source: GSK news)
Source: GSK news - November 9, 2009 Category: Pharmaceuticals Source Type: organizations

World Health Organization Grants Prequalification for Global Use to GSK’s 10-Valent Synflorix™ VaccineEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Endorsement is first for vaccine for pneumococcal disease - a life-threatening disease affecting many children; follows first-ever World Pneumonia Day (Source: GSK news)
Source: GSK news - November 6, 2009 Category: Pharmaceuticals Source Type: organizations

ViiV Healthcare launches: A new specialist HIV company dedicated to delivering advances in HIV treatment and careEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Dr Dominique Limet, CEO of ViiV Healthcare, promises 'relentless pursuit' of new treatments (Source: GSK news)
Source: GSK news - November 3, 2009 Category: Pharmaceuticals Source Type: organizations

Retigabine Regulatory UpdateEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (VRX) announced today that, on 30 October, they filed a New Drug Application with the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMEA), for retigabine, used as adjunctive therapy to treat adult epilepsy patients with partial-onset seizures (Source: GSK news)
Source: GSK news - November 2, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline and Human Genome Sciences announce positive results in second of two phase 3 trials of Benlysta in systemic lupus erythematosusEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
- Benlysta (belimumab) 10 mg/kg plus standard of care met its primary efficacy endpoint by achieving a statistically significant improvement in patient response rate versus placebo plus standard of care at Week 52 in BLISS-76 - Primary efficacy endpoint met in two pivotal Phase 3 trials, as specified by Special Protocol Assessment agreement with FDA (Source: GSK news)
Source: GSK news - November 2, 2009 Category: Pharmaceuticals Source Type: organizations

Results announcement for the third quarter 2009Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline plc (GSK) announced third quarter results for 2009 (Source: GSK news)
Source: GSK news - October 28, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic 2009 Influenza Update: Pandemrix™ data in an elderly populationEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today announced that this week, approximately half a million people will have received its pandemic H1N1 vaccine, Pandemrix™, as part of Government initiated vaccination programmes across Europe, which commenced earlier this month (Source: GSK news)
Source: GSK news - October 27, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline and Theravance commence Phase III Horizon programme to develop a next-generation treatment for COPDEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the first patient has commenced treatment as part of the Phase III programme being undertaken to develop a next-generation combination treatment for patients with chronic obstructive pulmonary disorder (COPD), a leading cause of chronic illness and death. (Source: GSK news)
Source: GSK news - October 27, 2009 Category: Pharmaceuticals Source Type: organizations

GSK and Genmab receive accelerated approval for Arzerra™Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GSK and Genmab announced the accelerated approval of ArzerraTM (ofatumumab) from the US Food and Drug Administration for use in patients with chronic lymphocytic leukemia (CLL) that is refractory to fludarabine and alemtuzumab. (Source: GSK news)
Source: GSK news - October 26, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic (H1N1) 2009 Influenza Update: Experience of GSK’s H1N1 adjuvanted vaccine, Pandemrix™, and preliminary paediatric resultsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today announced that, to date, more than 150,000 people have received GSK's pandemic H1N1 vaccine, Pandemrix™, as part of Government initiated vaccination programmes across Europe which commenced last week. (Source: GSK news)
Source: GSK news - October 23, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline and Human Genome Sciences announce full presentation at ACR of positive phase 3 study results for BENLYSTA in systemic lupus erythematosusEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
BENLYSTA (belimumab) significantly reduced SLE disease activity, disease flare rates and fatigue; significantly delayed time-to-first SLE disease flare; reduced prednisone use and improved health-related patient quality of life in the BLISS-52 study (Source: GSK news)
Source: GSK news - October 20, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic (H1N1) 2009 Influenza Update: Results from second clinical trial of GSK’s H1N1 adjuvanted vaccine confirm immune response and tolerabilityEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today announced results from a second clinical trial of its pandemic (H1N1) adjuvanted vaccine, which demonstrate that one dose of the vaccine can provide a strong immune response which exceeds criteria as defined by international licensing authorities using the lowest dose of antigen available in pandemic vaccines. (Source: GSK news)
Source: GSK news - October 16, 2009 Category: Pharmaceuticals Source Type: organizations

GSK’s Cervarix® becomes the first cervical cancer vaccine to gain approval in JapanEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Landmark approval paves the way for access to the vaccine for women in Japan. (Source: GSK news)
Source: GSK news - October 16, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline and Prosensa form alliance to fight Duchenne Muscular DystrophyEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) and Prosensa, the Dutch based biopharmaceutical company focusing on RNA modulating therapeutics, today announced that they have entered into an exclusive worldwide collaboration for the development and commercialisation of RNA based therapeutics for Duchenne Muscular Dystrophy (DMD) (Source: GSK news)
Source: GSK news - October 13, 2009 Category: Pharmaceuticals Source Type: organizations

GSK partners with UK Government and Wellcome Trust to stimulate innovation through the creation of a world-class science parkEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline plc (GSK) announced today that it has entered into a unique partnership with the UK Government, The Wellcome Trust and the East of England Development Agency (EEDA) to develop an innovative new biotechnology science park located at GSK’s site at Stevenage. (Source: GSK news)
Source: GSK news - October 13, 2009 Category: Pharmaceuticals Source Type: organizations

GSK’s Avodart® / tamsulosin combination showed benefits for men with prostate enlargementEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) announced today that final results from a large, 4-year study showed that Avodart (dutasteride) and tamsulosin combination treatment reduced the risk of acute urinary retention (AUR) or Benign Prostatic Hyperplasia* (BPH)-related surgery and reduced the risk of BPH clinical progression more than tamsulosin alone (Source: GSK news)
Source: GSK news - October 12, 2009 Category: Pharmaceuticals Source Type: organizations

GSK expands presence in China through strategic cooperation to form a joint venture on paediatric vaccinesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) and Jiangsu Walvax Biotech Company (Walvax) today announced a cooperation agreement to form a long-term Joint Venture (JV) to develop and manufacture paediatric vaccines for use in China. (Source: GSK news)
Source: GSK news - October 6, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline update: Government orders for pandemic (H1N1) 2009 vaccineEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain. (Source: GSK news)
Source: GSK news - October 6, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline Receives Unanimous FDA Panel Approval Recommendation for VOTRIENTEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously in support of the approval of VOTRIENT™ (pazopanib). (Source: GSK news)
Source: GSK news - October 5, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives European Commission ApprovalEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) confirmed today that the European Commission has granted marketing authorisation of GSK’s pandemic (H1N1) adjuvanted vaccine Pandemrix™ for protection against pandemic H1N1 2009 influenza. (Source: GSK news)
Source: GSK news - September 30, 2009 Category: Pharmaceuticals Source Type: organizations

GSK and UPCH to launch Lucozade across ChinaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today announced an exclusive agreement with President (Shanghai) Trading Co. Ltd, a wholly-owned trading arm of Uni-President China Holdings Ltd (UPCH), one of the leading food and beverage companies in China, to launch GSK's highly successful Lucozade drinks franchise across China (Source: GSK news)
Source: GSK news - September 28, 2009 Category: Pharmaceuticals Source Type: organizations

GSK provides update on regulatory filings for Zunrisa/RezonicEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) has made the difficult decision to discontinue the regulatory filings for Zunrisa/Rezonic (casopitant), which was being developed for chemotherapy-induced and post-operative nausea and vomiting. (Source: GSK news)
Source: GSK news - September 28, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic (H1N1) 2009 Influenza Update: GSK’s H1N1 ‘Pandemrix’ vaccine receives positive opinion from European RegulatorsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommends approval of GSK’s candidate pandemic (H1N1) adjuvanted vaccine Pandemrix™. (Source: GSK news)
Source: GSK news - September 25, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic (H1N1) 2009 Influenza Update: Initial results from first clinical trial of GSK’s H1N1 adjuvanted vaccineEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today announced results from its first clinical trial assessing use of its pandemic (H1N1) adjuvanted vaccine. (Source: GSK news)
Source: GSK news - September 14, 2009 Category: Pharmaceuticals Source Type: organizations

FDA Advisory Committee makes favorable recommendation for Cervarix, GlaxoSmithKline’s candidate cervical cancer vaccineEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that clinical data support both the efficacy and safety of CERVARIX®, the company’s candidate cervical cancer vaccine (12-1 and 11-1, respectively). (Source: GSK news)
Source: GSK news - September 9, 2009 Category: Pharmaceuticals Source Type: organizations

GSK and Brazil’s Fiocruz form partnership for new R&D effort and increased vaccine accessEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline plc (GSK) announced today that it has launched a unique partnership with Brazil’s Oswaldo Cruz Foundation (Fiocruz) to develop and manufacture vaccines for pressing public health priorities in Brazil. (Source: GSK news)
Source: GSK news - August 17, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic (H1N1) 2009 influenza updateEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GSK today issued an update on its progress to develop a vaccine against the Pandemic (H1N1) 2009 influenza virus, and announced that it has commenced the clinical development programme for its adjuvanted pandemic vaccine. Enrolment into this first study has been completed. (Source: GSK news)
Source: GSK news - August 14, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline update: Government orders for pandemic (H1N1) 2009 vaccineEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GSK is committed to supporting governments and health authorities around the world respond to the pandemic (H1N1) 2009 influenza strain. (Source: GSK news)
Source: GSK news - August 4, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline and Genmab announce top-line results for ofatumumab in rheumatoid arthritisEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GSK and Genmab A/S announced today preliminary top-line results from a Phase III study of ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate. (Source: GSK news)
Source: GSK news - July 29, 2009 Category: Pharmaceuticals Source Type: organizations

Regulatory update: mepolizumab for the treatment of hypereosinophilic syndrome (HES)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GSK today announced that it has notified the European Medicines Agency of its decision to withdraw the Marketing Authorisation Application (MAA) in the EU for mepolizumab for the treatment of hypereosinophilic syndrome (HES). (Source: GSK news)
Source: GSK news - July 29, 2009 Category: Pharmaceuticals Source Type: organizations

Amgen to collaborate with GSK to commercialize denosumab in Europe for postmenopausal osteoporosis (PMO)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Amgen to retain full rights for denosumab in the United States and Canada and for oncology indications in Europe. GlaxoSmithKline will commercialize denosumab for PMO and oncology in Emerging Markets. (Source: GSK news)
Source: GSK news - July 27, 2009 Category: Pharmaceuticals Source Type: organizations

GlaxoSmithKline completes acquisition of StiefelEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline plc (GSK) today announced that it has completed its acquisition of Stiefel Laboratories, Inc. (Source: GSK news)
Source: GSK news - July 22, 2009 Category: Pharmaceuticals Source Type: organizations

Pandemic (H1N1) 2009 influenza updateEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today issued an update on its progress to support governments and health authorities around the world respond to pandemic (H1N1) 2009 influenza. (Source: GSK news)
Source: GSK news - July 22, 2009 Category: Pharmaceuticals Source Type: organizations

Results announcement for the second quarter 2009Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Results announcement for Q2 2009 (Source: GSK news)
Source: GSK news - July 22, 2009 Category: Pharmaceuticals Source Type: organizations

GSK and Enigma Diagnostics Announce Commercial Partnership to Develop Point-of-Care Influenza DiagnosticsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) and Enigma Diagnostics Limited today announced that they have signed worldwide agreements to develop and supply the first point-of-care diagnostic influenza tests to identify specific influenza virus strains using its real-time Polymerase Chain Reaction (PCR) technology platform, the Enigma ML (Mini Laboratory). (Source: GSK news)
Source: GSK news - July 21, 2009 Category: Pharmaceuticals Source Type: organizations

Human Genome Sciences and GlaxoSmithKline announce positive Phase 3 study results for Benlysta™ in systemic lupus erythematosusEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Human Genome Sciences, Inc. and GSK today announced that Benlysta™ (belimumab, formerly LymphoStat-B®) 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: GSK news)
Source: GSK news - July 20, 2009 Category: Pharmaceuticals Source Type: organizations

GSK announces new commitments to fight HIV/AIDS in Sub-Saharan Africa - special focus on care and treatment of childrenEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Andrew Witty, Chief Executive Officer of GlaxoSmithKline, today announced a series of new initiatives targeted at improving research, development, and access to HIV/AIDS medicines for children in Sub-Saharan Africa and supporting healthcare for people living with HIV and AIDS. (Source: GSK news)
Source: GSK news - July 14, 2009 Category: Pharmaceuticals Source Type: organizations

WHO grants prequalification to Cervarix®: GSK’s vaccine to help combat cervical cancer in developing nationsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
The WHO decision is necessary for UN agencies and the GAVI Alliance to purchase the vaccine in partnership with developing countries and will help speed access to Cervarix globally. (Source: GSK news)
Source: GSK news - July 9, 2009 Category: Pharmaceuticals Source Type: organizations

Alnylam joins GSK in donating intellectual property to patent pool for neglected tropical diseasesEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GSK and Alnylam Pharmaceuticals, Inc. announced today that Alnylam will contribute more than 1500 issued or pending patents on its RNAi technology patent estate to the patent pool established by GSK earlier this year. (Source: GSK news)
Source: GSK news - July 8, 2009 Category: Pharmaceuticals Source Type: organizations

Landmark study for GSK’s cervical cancer vaccine published in The LancetEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
Largest efficacy trial of a cervical cancer vaccine showed Cervarix® protects against the five most common cancer-causing virus types (Source: GSK news)
Source: GSK news - July 7, 2009 Category: Pharmaceuticals Source Type: organizations

GSK further extends its product portfolio in the Middle East and North AfricaEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GSK today announced that it has acquired the branded generics business of Bristol Myers Squibb (BMS) in Lebanon, Jordan, Syria, Libya and Yemen for a cash consideration of $23.2m (£14.2m). (Source: GSK news)
Source: GSK news - July 2, 2009 Category: Pharmaceuticals Source Type: organizations

Seretide: Irish patent litigation updateEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (GSK) today announced that the Commercial Court in Dublin, Ireland, ruled in patent litigation regarding GSK’s product Seretide, an inhaled respiratory treatment for asthma and COPD. (Source: GSK news)
Source: GSK news - June 26, 2009 Category: Pharmaceuticals Source Type: organizations

Regulatory update for REZONIC™ (casopitant mesylate)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline confirmed today that it has received a complete response letterfrom the FDA related to the application for casopitant. (Source: GSK news)
Source: GSK news - June 23, 2009 Category: Pharmaceuticals Source Type: organizations

FDA extends review of Arzerra™ (ofatumumab)Email this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline and Genmab A/S today announced that the United States Food and Drug Administration (FDA) informed the companies that the agency has extended the action date for the ofatumumab BLA application by three months. (Source: GSK news)
Source: GSK news - June 16, 2009 Category: Pharmaceuticals Source Type: organizations

GSK and Chroma Therapeutics form alliance to develop novel macrophage-targeted drugsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline (LSE: GSK) and Chroma Therapeutics Limited announced today a collaboration to develop macrophage-targeted compounds using Chroma’s proprietary esterase-sensitive motif (ESM) technology, which adds amino acid esters to compounds with the aim of targeting the compounds to specific cells in the inflammatory disease process. (Source: GSK news)
Source: GSK news - June 16, 2009 Category: Pharmaceuticals Source Type: organizations

GSK announces a strategic alliance with Dr. Reddy’s to further accelerate sales growth in emerging marketsEmail this article to a colleague. Save this article to My Clippings. Discuss or comment on this article.
GlaxoSmithKline plc (GSK) today announced an agreement with Dr. Reddy’s Laboratories Ltd (Dr. Reddy’s) to develop and market selected products across an extensive number of emerging markets, excluding India. (Source: GSK news)
Source: GSK news - June 15, 2009 Category: Pharmaceuticals Source Type: organizations