GlaxoSmithKline News and Research

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Bedford Labs launches cancer drug Topotecan Hydrochloride for Injection

Bedford Laboratories, a division of Ben Venue Laboratories, Inc., is pleased to announce the addition of Topotecan Hydrochloride for Injection, 4 mg (base)/vial to its diverse portfolio. Topotecan is AP Bioequivalent to the reference listed drug Hycamtin® (topotecan HCl) for injection by GlaxoSmithKline.

19 Apr 2011

U.S. District Court grants preliminary injunction to POZEN's Treximet patent lawsuit

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, announced today that the U.S. District Court for the Eastern District of Texas has granted a preliminary injunction ordering Par Pharmaceutical Inc. not to make, use, sell, offer to sell, or import into the United States a generic version of sumatriptan/naproxen sodium that competes with Treximet sold by GlaxoSmithKline in the United States under an exclusive license from the Company.

15 Apr 2011

GSK announces safety profile of orlistat and alli

GlaxoSmithKline (GSK) is committed to ensuring that consumers and physicians understand the safety profile of orlistat and alli. alli is safe and effective when used as directed. Orlistat is minimally absorbed in the blood and works locally in the gastro-intestinal tract. GSK continues to proactively monitor for the safety of orlistat and share all relevant information with regulatory agencies.

15 Apr 2011

Consumer group calls for ban on weight loss drugs Alli and Xenical

According to the consumer watchdog Public Citizen, the weight loss drugs Alli and Xenical should be removed from the market because of the growing risk of side effects that include liver damage, pancreatitis and kidney stones.

15 Apr 2011

Marking World Health Day, WHO warns misuse of antibiotics undermining global fight against infectious diseases

U.N. officials on Thursday marked World Health Day with a warning that "the misuse and irrational use of antibiotics has undermined the global fight against tuberculosis and malaria, warning of a possible return to the days before the drugs were developed," and called for urgent action to control the spread of drug resistance, Reuters reports.

8 Apr 2011

Lecture to explain science behind modern pharmaceutical products

The science behind the creation of medicines is the subject of a lecture at the University of Greenwich's Medway Campus on Wednesday, April 13.

8 Apr 2011

Strathclyde establishes new EPSRC Centre to improve chemical manufacturing

An EPSRC Centre for revolutionising the way pharmaceuticals and other chemicals are made is being officially launched today.

8 Apr 2011

GlaxoSmithKline, XenoPort receive FDA approval for Horizant to treat RLS

On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets, a once-daily treatment for moderate-to-severe restless legs syndrome.

8 Apr 2011

FDA approves Horizant Extended-Release Tablets for Restless Legs Syndrome

GlaxoSmithKline and XenoPort, Inc. announced Wednesday that the U.S. Food and Drug Administration (FDA) has approved Horizant™ (gabapentin enacarbil) Extended-Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome in adults. Horizant is not recommended for patients who are required to sleep during the daytime and remain awake at night.

7 Apr 2011

Ascletis raises $100 million in committed financing

Ascletis, Inc., a U.S.-China specialty life sciences venture focused on cancer and infectious disease therapeutics, today announced the company's formation and completion of a Series A private equity financing. Ascletis has raised US$100 million in committed financing including a first tranche of US$50 million. The investors, led by Hangzhou Binjiang Investment Holding Co., Ltd., included private entrepreneurs from China and other countries including the United States.

6 Apr 2011

FDA to discuss 2008 immunogenicity directives with European industry experts at Pharma IQ

This May, Joao Pedras-Vasconcelos, Visiting Associate, Therapeutic Proteins CBER from FDA will meet with European industry experts at Pharma IQ's to discuss FDA directives on immunogenicity introduced in 2008.

6 Apr 2011

Aptiv Solutions creates Adaptive Clinical Trials Innovation Center

Aptiv Solutions, a global biopharmaceutical and medical device development services company, announced today the creation of an Adaptive Clinical Trials Innovation Center.

6 Apr 2011

Medical industry veteran set to play key role as Microvisk gears up to launch Smartstrip®

Microvisk Technologies, the developer of a handheld system to monitor the blood clotting status of patients taking the drug Warfarin, today announced that it has strengthened its Board with the appointment of medical industry veteran, Bill Moffitt, as Chairman and Peter Whitehouse as CFO.

4 Apr 2011

The Wall Street Journal: Pfizer, Glaxo detail fees paid to doctors

Pfizer Inc. paid $177 million and GlaxoSmithKline PLC paid $85 million during 2010 to U.S. doctors and institutions for their work on clinical trials, consulting, speaking and other items, the companies disclosed Thursday.

1 Apr 2011

First Edition: April 1, 2011

Today's health policy news coverage helps fill in the details of the much-anticipated rule for accountable care organizations, which was released yesterday by the Obama administration.

1 Apr 2011

GSK to implement Medidata Designer for its Clinical Research and Development organization

Medidata Solutions, a leading global provider of SaaS-based clinical technology solutions, today announced that GlaxoSmithKline has decided to implement Medidata Designer, an innovative study design optimization solution, for its Clinical Research and Development organization.

1 Apr 2011

Dr. Reddy’s acquires GSK's US penicillin facility and products

Dr. Reddy's Laboratories today announced the completion of the acquisition of GlaxoSmithKline's United States oral penicillin facility and product portfolio pursuant to the agreement signed and announced by the companies on Nov 23, 2010.

30 Mar 2011

Accelrys announces Modeling and Simulation Suite for optimizing R&D value chain

Accelrys, Inc., a leading scientific enterprise R&D software and services company, today announced the Accelrys Modeling and Simulation Suite, a pillar of the new Accelrys Enterprise R&D Architecture.

30 Mar 2011

Valeant receives European Commission marketing authorization for Trobalt

Meda's partner for retigabine, Valeant Pharmaceuticals International, Inc., today announced that the European Commission has granted the marketing authorization for Trobalt™ (retigabine) in the epilepsy therapy area.

30 Mar 2011

EC grants marketing authorization for GSK, Valeant's Trobalt to treat epilepsy

GlaxoSmithKline and Valeant Pharmaceuticals International, Inc. announced today that the European Commission has granted marketing authorisation for Trobalt as an adjunctive treatment of partial onset seizures, with or without secondary generalisation in adults aged 18 years and above with epilepsy.

30 Mar 2011