GlaxoSmithKline News and Research

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Extreme morning sickness drug comes at a price

Women, who suffer from an extreme form of morning sickness called hyperemesis gravidarum (HG), are shelling out $7,000 for a drug not yet approved for use by expectant mums because they are desperate to control their illness. HG leads to severe nausea, dehydration and fatigue and may require hospitalization. It affects up to 3 per cent of pregnant women - about 9,000 per year in Australia. It may lead to termination of the pregnancy.

31 Jan 2011

McGill, GSK enter collaborative research agreement on cystic fibrosis

McGill University and GlaxoSmithKline plc have signed a collaboration agreement to develop a potential breakthrough approach to treat cystic fibrosis, a fatal genetic disease. The trans-Atlantic effort between researchers from McGill's Faculty of Medicine and their GSK collaborators in the UK, will focus on developing molecules that could treat the disease by correcting the dysfunction caused by the mutated gene.

28 Jan 2011

FDA issues Complete Response letter for Avodart sNDA for reduction of prostate cancer risk

GlaxoSmithKline (GSK) today announced that the Company has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for the supplemental New Drug Application (sNDA) for Avodart® (dutasteride) for reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA).

27 Jan 2011

ChemoCentryx commences CCX832 Phase I trial in patients with psoriasis

ChemoCentryx, today announced the initiation of a Phase I clinical trial of CCX832, an orally-administered small molecule that is a potent and selective inhibitor of the chemoattractant receptor, ChemR23.

26 Jan 2011

Triad alcohol prep pads with ARIXTRA Starter Kits not to be used

GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.

25 Jan 2011

GSK, Valeant receive European CHMP positive opinion for Trobalt

GlaxoSmithKline and Valeant Pharmaceuticals International, Inc. announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion, recommending marketing authorisation for Trobalt™ (retigabine) as an adjunctive treatment of partial onset seizures, with or without secondary generalisation in adults aged 18 years and above with epilepsy.

21 Jan 2011

Routine rotavirus vaccine shows a significant drop in diarrhea cases: Study

A latest study has shown that the rotavirus vaccines have helped drastically reduce hospital visits around the world. Rotavirus can lead to fatal cases of diarrhea in children and causes half a million deaths in kids under five each year around the world. Developing countries are particularly at risk.

20 Jan 2011

GSK and Prosensa commence GSK2402968 Phase III study in DMD

GlaxoSmithKline and Prosensa today announced that the first patient has commenced treatment in the Phase III clinical study investigating GSK2402968, in ambulant boys with Duchenne Muscular Dystrophy (DMD), who have a dystrophin gene mutation amenable to an exon 51 skip (up to 13% of boys with DMD). Commencement of this study confirms previously announced plans to progress this asset into Phase III.

20 Jan 2011

RTS,S offers 46 percent protection against malaria for at least 15 months after vaccination, Study finds

A Phase II trial published Friday in Lancet Infectious Diseases has shown that RTS,S, the "experimental malaria vaccine from GlaxoSmithKline provides African children with long-lasting protection" against malaria, Reuters reports.

18 Jan 2011

GSK, ChemoCentryx initiate '786 Phase III clinical trial for Crohn's disease

GlaxoSmithKline and ChemoCentryx, announced today that the first patient with Crohn's disease has initiated treatment in the initial pivotal induction study comparing Traficet-EN, now designated GSK1605786 ('786), to placebo.

12 Jan 2011

GSK, Epizyme enter partnership to discover, develop, and market epigenetic therapeutics

Epizyme today announced a worldwide strategic alliance with GlaxoSmithKline to discover, develop, and market novel small molecule therapeutics targeting histone methyltransferases, an important class of epigenetic enzymes, for the treatment of cancer and other diseases.

11 Jan 2011

Old flu jabs from pandemic to combat this winter’s peak

With rise of incidence of flu this winter emergency stocks of the vaccine are being released. A review is to be carried out into whether vaccines should be purchased centrally next year in order to avoid shortages. At present the GPs can procure the jabs directly from manufacturers according to their estimates of patient requirement.

9 Jan 2011

Antigenics announces name change to Agenus

Antigenics Inc. today announced that effective immediately it is changing its name to Agenus Inc. The company's stock will continue to be traded on NASDAQ under the symbol AGEN. The new name reflects the broadening of the company's product portfolio of clinical candidates beyond autologous antigen-based vaccines, as well as its commitment to actively pursuing licensing opportunities to leverage its development capabilities and expand its product portfolio.

6 Jan 2011

Genocea announces close of $35 million Series B venture financing round

Genocea Biosciences Inc., a vaccine discovery and development company pioneering a new class of T cell-based vaccines, today announced that it has closed a $35 million Series B round of venture financing, with new investors Johnson & Johnson Development Corporation (JJDC), Skyline Ventures and MP Healthcare Venture Management, Inc. (MPH) joining existing investors Polaris Venture Partners, Lux Capital Management, SR One, Cycad Group, Auriga Partners and Morningside Ventures.

3 Jan 2011

Financial Times examines how Brazil's state-run drug sector is engaging in partnerships at home, abroad

"Dilma Rousseff had barely been confirmed as Brazil's new president in November when she made her first foreign visit, to Mozambique," which "included a symbolic stop-off at a pharmaceutical factory that is under construction in preparation for opening in 2014. … The plant will produce a range of medicines for one of its leading lusophone - Portuguese-speaking - African partners, marking the resurgent power and growing reach of its sponsor, Brazil's own state-led drug sector," the Financial Times writes in an article that examines the partnerships Brazil is establishing at home and abroad.

24 Dec 2010

SEEK announces new joint venture entity with Pernix Therapeutics for antitussive drug development

SEEK, a leading UK privately-owned drug-discovery group, is pleased to announce the establishment of a new joint venture entity with Pernix Therapeutics Holdings, an integrated specialty pharmaceutical company focused primarily on the United States pediatric market.

20 Dec 2010

GSK, Impax enter global development, commercialization agreement for PD investigational product, IPX066

GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (Impax), today announced an agreement for the development and commercialization of IPX066, Impax's novel extended release carbidopa-levodopa product, outside the United States and Taiwan. IPX066, an investigational product under development for the treatment of Parkinson's Disease (PD), is currently in Phase III clinical trials.

17 Dec 2010

GSK to deploy BioClinica's Trident IWR system across Phase I-IV clinical trials

BioClinica®, Inc.,, a global provider of clinical trial management services, today announced that GlaxoSmithKline LLC ("GSK") has signed a multi-year enterprise technology agreement to deploy BioClinica's Trident IWR (Interactive Web Response) system across its Phase I-IV clinical trials.

From Clario 16 Dec 2010

Unigene enters agreement with GSK to advance oral PTH Phase 2 program for osteoporosis

Unigene Laboratories, Inc. today announced that the Company entered into an amended and restated exclusive worldwide license agreement with GlaxoSmithKline (GSK) to develop and commercialize an oral formulation of a recombinantly produced parathyroid hormone (PTH) analog for the treatment of osteoporosis in postmenopausal women and plans to initiate a Phase 2 study in the first quarter of 2011.

14 Dec 2010

GAVI Alliance launches pneumonia vaccine project in Nicaragua

"A new vaccine against the most deadly forms of pneumonia, one of the world's biggest killers of children, [was] launched in Nicaragua [on Sunday] as part of an effort to prevent 700,000 deaths in poorer countries by 2015," Reuters reports (Kelland, 12/10).