GlaxoSmithKline News and Research

RSS

Fero Industries provides comments concerning FDA advisory panel recommendation on diabetes drug Avandia

Fero Industries, Inc. is pleased to provide these comments regarding the recent Food and Drug Administration advisory panel recommendation concerning the GlaxoSmithKline PLC diabetes drug Avandia. The FDA advisory panel has recommended that the agency keep diabetes drug Avandia on the U.S. market despite data clearly showing an increased risk of a heart attack and that GSK covered up their own research that first identified the problem.

20 Jul 2010

AIDS 2010 studies, releases: Treating HIV-positive patients with ARVs drove down number of new HIV infections, study finds

"Treating HIV patients with cocktails of AIDS drugs helps to stop them spreading the infection further and more than halved the number of new HIV diagnoses in a study in Canada, scientists said on Sunday," Reuters reports.

20 Jul 2010

Pharma industry leaders reduce R&D time, costs with aspenONE Process Development software

Aspen Technology, Inc., a leading provider of software and services to the process industries, today announced that GlaxoSmithKline, AstraZeneca and other pharmaceutical industry leaders are reducing their research and development time and costs using newly patented technology that is part of AspenTech's aspenONE Process Development for Pharmaceuticals software.

19 Jul 2010

Amira achieves two clinical development milestones in FLAP program for asthma

"Amira Pharmaceuticals, Inc. announced today that its FLAP (5-lipoxygenase-activating protein) program, which is partnered with GlaxoSmithKline, has achieved two clinical development milestones."

19 Jul 2010

FDA warns public over safety of stolen Advair Diskus inhalers

The FDA is warning the public that certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

17 Jul 2010

ACTOS offers safety profile regarding risk of CV events in people with type 2 diabetes: Takeda

The U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting primarily focused on reviewing the cardiovascular safety of rosiglitazone, as presented by the FDA and GlaxoSmithKline. Following this two day discussion, Takeda Pharmaceuticals North America, Inc. ("Takeda") underscores its position that ACTOS (pioglitazone HCl) offers an established safety profile regarding the risk of CV events in people living with type 2 diabetes.

16 Jul 2010

Glaxo announces a $2.3 billion in legal liability charges

British pharmaceutical giant GlaxoSmithKline, announced this Thursday that its second-quarter charges related to legal cases involving the two drugs Avandia (diabetes drug) and Paxil (drug for anxiety and depression) would run up to $2.36 billion. Avandia’s use and its potential risk of causing heart problems were being debated this week by an advisory panel to the US Food & Drugs Administration (FDA).

16 Jul 2010

GSK confirms FDA advisory committees' vote to allow Avandia to remain on the market

GlaxoSmithKline confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions to withdrawal from the U.S. market.

15 Jul 2010

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Nabi Biopharmaceuticals announced today that it has completed enrollment in the first Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.

15 Jul 2010

Amira granted UK patents for AM103, AM803 FLAP inhibitors for respiratory disorders

Amira Pharmaceuticals, Inc. today announced that the U.K. Intellectual Property Office has granted patent number GB2431927, titled, "5-Lipoxygenase Activating Protein (FLAP) Inhibitors," which includes coverage of Amira's AM103 and AM803 FLAP inhibitors for the treatment of respiratory disorders.

14 Jul 2010

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

GlaxoSmithKline News and Research

Fero Industries provides comments concerning FDA advisory panel recommendation on diabetes drug Avandia

AIDS 2010 studies, releases: Treating HIV-positive patients with ARVs drove down number of new HIV infections, study finds

Pharma industry leaders reduce R&D time, costs with aspenONE Process Development software

Amira achieves two clinical development milestones in FLAP program for asthma

FDA warns public over safety of stolen Advair Diskus inhalers

ACTOS offers safety profile regarding risk of CV events in people with type 2 diabetes: Takeda

Glaxo announces a $2.3 billion in legal liability charges

GSK confirms FDA advisory committees' vote to allow Avandia to remain on the market

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Amira granted UK patents for AM103, AM803 FLAP inhibitors for respiratory disorders

FDA to decide on Avandia’s fate Wednesday

Human Genome Sciences, Lonza announce commercial supply agreement for BENLYSTA

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

Glaxo’s diabetes pill Avandia under FDA scrutiny again

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

GSK, Genmab amend ofatumumab agreement

Aptuit to acquire GSK's research business in Verona

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

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

Greenwire/New York Times examine dengue vaccine development

Advancing Intracellular Delivery with LumiPore®

How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

The role of UV-Vis in biopharma QC

Latest News