GlaxoSmithKline News and Research

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FDA approves Hiberix Haemophilus influenzae type b vaccine

In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline (NYSE: GSK) has received accelerated approval from the FDA (Food and Drug Administration) for Hiberix((R)) [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] as a booster dose in children 15 months through four years of age. Hib is an often severe and potentially deadly bacterial infection that can cause meningitis.

19 Aug 2009

Xceleron to acquire an Accelerator Mass Spectrometry instrument under agreement with GlaxoSmithKline

XCELERON, a leader in the field of ultra-sensitive bioanalytical studies supporting clinical research, today announced that it has signed a second Master Service Agreement with GlaxoSmithKline. Under the terms of this agreement, Xceleron will provide analytical support to GlaxoSmithKline and its affiliated research organizations. As part of the deal, Xceleron will increase capacity through the acquisition of an Accelerator Mass Spectrometry (AMS) instrument.

19 Aug 2009

GSK starts testing H1N1 vaccine; Opinion piece addresses U.S. role in helping developing countries procure vaccine

"GlaxoSmithKline has started testing its pandemic H1N1 swine flu vaccine in humans, and expects to start giving the results to government agencies next month, the drugmaker said on Friday," Reuters reports. The company "plans to conduct 16 different trials of the vaccine and to test 9,000 people in total across Europe, Canada and the United States," according to the news service (Deighton, 8/14).

17 Aug 2009

Ranbaxy receives approval to market Sumatriptan Succinate tablets

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received final approval from the U.S. Food and Drug Administration to manufacture and market Sumatriptan Succinate Tablets, 25 mg (base), and 50 mg (base).

12 Aug 2009

Researchers launch study into search-and-destroy antigen for deadly skin cancer

UT Southwestern Medical Center researchers are studying a new antigen to see whether it can track down and kill cancer cells in patients with recurring melanoma, the leading cause of skin cancer deaths.

11 Aug 2009

ISI to host eSolutions Conference in September 2009

Image Solutions Inc. (ISI), a leading provider of electronic submissions management and publishing solutions for the life sciences industry, has unveiled a prestigious line-up of speakers for its annual eSolutions Conference in Barcelona, Spain, this September to support an agenda aimed at reinventing the regulatory function.

10 Aug 2009

2 billion worldwide could het H1N1, says WHO

The WHO on Tuesday maintained that roughly two billion people could become infected with the H1N1 (swine flu) virus, Reuters reports.

6 Aug 2009

Tamiflu-resistant swine flu identified along Texas-Mexico border

PAHO on Monday announced it had found Tamiflu-resistant H1N1 (swine) flu along the Texas-Mexico border, Agence-France Press reports. The discovery of several cases in El Paso and McAllen, Texas, adds the U.S. to a growing list of countries with antiviral-resistant H1N1, such as Canada, Denmark, Hong Kong and Japan. "Experts had gathered in La Jolla on Monday to discuss the response to the outbreak, and warned that resistant strains were likely emerging because of overuse of antivirals like Tamiflu," the news service writes (8/3).

4 Aug 2009

Massachusetts to restore immigrant health care, Colorado Medicaid list grows, Obama in North Carolina

Massachusetts lawmakers will vote today to provide $40 million to restore health care coverage for legal immigrants. In Colorado, a 14 percent spike in Medicaid capped a record year for enrollment.

30 Jul 2009

Swine Flu - getting drugs to the market more rapidly

The pharmaceutical industry has been up in arms this year. Giants such as Pfizer, GSK and AstraZeneca are looking for deals in the downturn whilst competing against increasing generic competition as some of the best selling medicines are coming off patent. In addition to the sectors ever-changing landscape companies are under tremendous pressure from governments to combat the Swine flu pandemic that has gripped the world.

29 Jul 2009

Health lobbying means cash infusion for candidates, TV stations

"Health care groups working feverishly to shape -- or kill -- an industry-wide reform bill are lavishing campaign cash on the politicians at the center of the debate," The Salt Lake (Utah) Tribune reports.

28 Jul 2009

Amgen and GlaxoSmithKline to collaborate on Denosumab for postmenopausal osteoporosis

Amgen and GlaxoSmithKline (GSK) today announced a collaboration in which the companies will share commercialization of Amgen's monoclonal antibody denosumab for postmenopausal osteoporosis (PMO) in Europe, Australia, New Zealand and Mexico once the product is approved in these countries.

28 Jul 2009

Some health groups increase lobbying spending, but only a slight rise overall

"Drug makers, advocacy groups, biotechnology firms and insurance companies have ratcheted up efforts to offer their two cents - and in most cases much, much more - in influencing the health care legislation now working its way through Congress," The New York Times reports.

22 Jul 2009

FDA approves vaccine for 2009-2010 flu season

The U.S. Food and Drug Administration today announced that it has approved a vaccine for 2009-2010 seasonal influenza in the United States.

20 Jul 2009

GlaxoSmithKline pledges $97 million investment in AIDS drugs for Africa, allows South African drugmaker to produce generic second-line treatment

GlaxoSmithKline (GSK) on Tuesday announced plans to invest $97 million over 10 years "to improve research, development and access to AIDS drugs in Africa," Reuters reports.

15 Jul 2009

WHO approves second HPV vaccine

The WHO announced Thursday it had approved a second cervical cancer vaccine, opening "U.N. agencies and partners [to] now officially buy millions of doses of the vaccine for poor countries worldwide," where an estimated 80 percent of the 280,000 annual deaths from cervical cancer occur each year, the AP/Google.com reports (7/9).

12 Jul 2009

WSJ examines pharmaceutical companies expansion into developing countries

The Wall Street Journal examines the "strategic shift in the $770 billion pharmaceutical industry to target the working poor in the developing world" through the eyes of a Pfizer pharmaceutical representative working in the slums overlooking Caracas, Venezuela.

7 Jul 2009

PATRICIA trial shows HPV vaccine effective in prevention of cervical lesions

The final analysis of the PATRICIA study shows that the HPV-16/18 AS04-adjuvanted vaccine (GlaxoSmithKline) has high efficacy against the precancerous cervical lesions that can eventually lead to cervical cancer.

6 Jul 2009

Chantix and Zyban to get boxed warnings on serious mental health events

The U.S. Food and Drug Administration has announced that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion). The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts when taking these drugs.

1 Jul 2009

PEPFAR and IDUs; economic crisis and health; human-rights and pharmaceutical companies

Although PEPFAR has helped to provide "antiretroviral therapy to 2.1 million people with HIV, almost all of whom live in sub-Saharan Africa, and has spent more than US$18 billion on the continent" it has failed to reach "thousands of injecting drug users in PEPFAR countries in Africa, many of whom have HIV," according to the authors of a recent comment in the journal Lancet.

21 Jun 2009