GlaxoSmithKline News and Research

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FDA to decide on Avandia’s fate Wednesday

Avandia, a drug used as a treatment for type 2 diabetes was approved for use in 1999. However controversies have surrounded it since 2007 when a Cleveland Clinic cardiologist Steven E. Nissen published a study in the acclaimed New England Journal of Medicine that concluded that the drug significantly increased the risk for heart problems like heart attacks, heart failure and deaths.

13 Jul 2010

Human Genome Sciences, Lonza announce commercial supply agreement for BENLYSTA

Human Genome Sciences, Inc. and Lonza today announced an agreement for the future commercial supply of BENLYSTA® (belimumab), which is currently under regulatory review in the United States and Europe as a potential new treatment for systemic lupus erythematosus (SLE). BENLYSTA is being developed by HGS and GlaxoSmithKline (GSK) under a co-development and commercialization agreement entered into in 2006.

13 Jul 2010

Vaccine manufacturers may be able to produce lower-cost HPV vaccines, say researchers

Vaccine manufacturers in India and other developing countries may be able to produce a lower-cost HPV vaccine in spite of the complicated array of patent protections on the technology, say researchers at the Duke Institute for Genome Sciences & Policy. At a cost of at least $300 for the three-dose regimen, the blockbuster HPV vaccines, including Gardasil- from Merck and Cervarix- from GlaxoSmithKline, are some of the most expensive ever introduced.

12 Jul 2010

Glaxo’s diabetes pill Avandia under FDA scrutiny again

GlaxoSmithKline (GSK) is under Food and Drug Administration (FDA) scrutiny again. This is for its diabetes pill Avandia which is under review for the second time in three years.

11 Jul 2010

GSK, XenoPort disappointed with GSK1838262/XP13512 phase 2b study for migraine headaches

GlaxoSmithKline and XenoPort, Inc. announced today that GSK1838262/XP13512 (gabapentin enacarbil) did not demonstrate a statistically significant improvement compared to placebo as a prophylactic treatment for migraine headaches. This phase 2b dose-ranging study evaluated the efficacy, safety and tolerability of GSK1838262 in adults diagnosed with migraine headache (with or without aura) according to the International Headache Society criteria.

8 Jul 2010

GSK, Genmab amend ofatumumab agreement

GlaxoSmithKline and Genmab A/S announced today an amendment to the ofatumumab co-development and commercialisation agreement. Under the terms of the amendment, GSK will take responsibility for developing ofatumumab in autoimmune indications whilst continuing to jointly develop ofatumumab with Genmab in oncology indications.

2 Jul 2010

Aptuit to acquire GSK's research business in Verona

GlaxoSmithKline (GSK) and Aptuit, Inc. announced today that they have finalized an agreement for Aptuit to acquire operations at GSK's Medicines Research Centre in Verona, Italy. The arrangement, which is effective as of July 1, 2010, provides for ongoing employment of the staff at the centre and for Aptuit to supply GSK with R&D services from the facilities. Financial terms have not been disclosed.

1 Jul 2010

Researchers report no increased rate of heart attack in patients taking rosiglitazone

The diabetes drug rosiglitazone has been under intense scrutiny since a 2007 study in the New England Journal of Medicine looked at more than 40 clinical trials and linked the drug's use with increased risk of heart attack and death from heart disease.

1 Jul 2010

2 new studies add to evidence of risks with diabetes drug Avandia as FDA prepares to debate it's safety

The Washington Post: Two new studies provide evidence "that the diabetes drug Avandia increases the risk of heart problems and strokes, renewing questions about the safety of the medication. ... The new research, released Monday, should prompt the Food and Drug Administration to remove the drug from the market, according to the researchers who led the analyses and several drug-safety advocates.

30 Jun 2010

Greenwire/New York Times examine dengue vaccine development

Greenwire/New York Times reports on the growing number of cases of dengue worldwide, including the CDC's report last month that the virus has now been locally acquired in the continental U.S. for the first time in 65 years. "While a few cases were reported earlier, they were primarily in Americans who had caught the virus abroad or at the Texas-Mexico border," the news service writes.

30 Jun 2010

Rosiglitazone therapy associated with increased risk for heart attack: Study

Eleven years after the introduction of the diabetes drug rosiglitazone, data from available clinical trials demonstrate an increased risk for heart attack associated with its use and suggest an unfavorable benefit-to-risk ratio, according to a report posted online today that will appear in the July 26 print issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

29 Jun 2010

Research provides hope and encouragement to people living with lupus

Research presented during the 9th International Lupus Congress held in Vancouver, Canada from June 24-27, 2010 should give hope and encouragement for the future of the treatment and management of lupus to the 1.5 million Americans and 5 million people worldwide living with lupus. In recent years, there have been significant advances made in many areas of lupus research including the development of new treatments, adult stem cell transplantation, genetics, lupus-related cardiovascular disease, and quality of life issues for people with lupus.

25 Jun 2010

Report identifies FDA's weaknesses in monitoring foreign drug trials

The FDA inspected 0.7 percent of foreign clinical drug trial sites in 2008 while 80 percent of applications approved for marketing that year contained data from foreign drug trials, according to a report (.pdf) from the Inspector General of HHS, CBS News reports (Strickler, 6/22).

24 Jun 2010

BioWa signs two licensing agreements with GSK

BioWa, Inc. announced today that it has entered into two agreements with GlaxoSmithKline. BioWa and GSK have amended their existing 2007 arrangement in order to provide GSK with extended access to BioWa's POTELLIGENT Technology platform for the research, development and commercialization of their antibody therapeutics with enhanced antibody-dependent cellular cytotoxicity. The second license agreement provides GSK with access to BioWa's COMPLEGENT Technology for enhancing the complement-dependent cytotoxicity of select GSK therapeutic antibodies.

23 Jun 2010

Misperceptions about 'light,' 'low,' 'mild' cigarettes

Today, new legislation will go into effect surrounding the ban of word descriptors such as "light," "low," and "mild" on all packaging and advertising of existing cigarettes and smokeless products. However, a new survey, sponsored by GlaxoSmithKline (GSK) Consumer Healthcare, shows that many smokers will choose the cigarettes in lighter-colored packaging because they incorrectly believe these cigarettes would be less harmful to their health or make it easier to quit smoking.

23 Jun 2010

GSK, Medivir sign exclusive agreement for commercialization of Xerclear

GlaxoSmithKline and Medivir today announced an exclusive agreement for the commercialization of cold sore treatment, Xerclear (acyclovir and hydrocortisone) for non-prescription use (OTC) in key global markets. Xerclear is the first and only topical herpes labialis (cold sores) treatment clinically proven to help prevent cold sore lesions appearing.

23 Jun 2010

European drugmakers lead in making medicines available to developing world, Index says

European drug companies came out ahead of their U.S. counterparts in making medicines available to people in developing countries, but their lead is beginning to shrink, according to the Access to Medicines Index, released on Monday, Reuters reports (Kelland, 6/21).

23 Jun 2010

Opinions: Canada's role in global health; Drug licensing agreements promote drug access; Funding for USAID, state; Haiti

After outlining the work of the Global Fund to Fight AIDS, Tuberculosis and Malaria, Michel Kazatchkine, the organization's executive director, highlights the role Canada can play in determining "whether the world can overcome AIDS, tuberculosis and malaria" in a Toronto Star opinion piece, noting the upcoming G8 and G20 summits, as well as the Millennium Development Goal meeting later this year.

23 Jun 2010

EIN News expands health news-monitoring coverage

With impending lawsuits from states, an uprising from the Tea Party sect and an outpouring of rhetoric from both major parties, the healthcare debate is far from over.

21 Jun 2010

GSK acquires exclusive marketing rights for new topical patch from Labtec GmbH

In a recently finalized license agreement, the Consumer Healthcare division of GlaxoSmithKline acquired the exclusive marketing rights for a new topical patch for the treatment of cold sores from Labtec GmbH, the transdermal and topical patch specialist based in Langenfeld, Germany. The agreement designates Labtec as the exclusive manufacturer.

21 Jun 2010