GlaxoSmithKline News and Research

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GSK updates long-term survival data of BEXXAR Therapeutic Regimen for Non-Hodgkin's lymphoma

GlaxoSmithKline announced today updated long-term survival data from two Phase II studies of BEXXAR® (tositumomab and iodine I-131 tositumomab) used in either patients with previously untreated cancer of the immune system (follicular lymphoma) or in patients with cancer of the lymphocytes (non-Hodgkin's lymphoma, NHL) that no longer responded to rituximab.

9 Dec 2009

Also in Global Health news: Rotavirus vaccine; guinea worm eradication; health systems; Zulu King calls for male circumcision

The West African Rotavirus Advisory Board is calling on governments to vaccinate children against rotavirus, IRIN reports. At a recent meeting in Dakar, Senegal, which was "financed by GlaxoSmithKline, makers of one of two rotavirus vaccines" the board issued a document recommending that governments "immediately recognize the magnitude of the rotavirus problem and make vaccination against the virus a priority" (12/8).

8 Dec 2009

Galapagos NV receives milestone payment to initiate Phase I clinical trial of GLPG0555 drug

Galapagos NV (Euronext: GLPG) announced today that it has initiated clinical Phase I development of the first small molecule candidate from its arthritis alliance with GlaxoSmithKline (GSK).

8 Dec 2009

Scientists report cervarix vaccine offers protection against cervical cancer

The Cervarix vaccine provides protection against two types of human papillomavirus (HPV) for more than six years, US scientists have reported.

5 Dec 2009

GSK places a batch of AS03 adjuvanted H1N1 vaccine on hold

Following reports from Canada's Public Health Agency that six patients had suffered allergic reactions after receiving the shot, GlaxoSmithKline plc has voluntarily placed a hold on a single batch of the AS03 adjuvanted H1N1 vaccine Arepanrix in Canada as a precautionary measure.

4 Dec 2009

Santaris Pharma's LNA technology based microRNA-targeted therapy holds promise for HCV

A study published online in this week's Science shows that SPC3649, a breakthrough microRNA-targeted therapy developed by Santaris Pharma A/S using its proprietary Locked Nucleic Acid (LNA) technology, holds promise as a novel treatment for patients infected with the Hepatitis C virus (HCV).

4 Dec 2009

UK DFID awards CNTD £10M in elimination of elephantiasis initiative

The Centre for Neglected Tropical Diseases (CNTD) at the Liverpool School of Tropical Medicine has been awarded £10 million by the UK Department for International Development (DFID) to support endemic countries in tackling lymphatic filariasis (LF) - a crippling disease more commonly known as elephantiasis.

3 Dec 2009

U.S. H1N1 cases decreasing, CDC says; HHS to review approach to health-threat preparedness

The number of H1N1 (swine flu) cases in the U.S. appears to be decreasing, the CDC said Tuesday, CQ HealthBeat reports. "Flu was widespread in 32 states by the end of the week of Nov. 21, a decrease from 43 states in the prior week and 46 states earlier this fall, according to the CDC," the news service writes. "

3 Dec 2009

Several new vaccines require booster shots to remain effective during a lifetime: Study

Preventing disease is the goal of every health care provider and fortunately every year, new vaccines are being added to assist in disease prevention. But do all vaccines boost immunity for the same period of time? And, if not, when are additional 'booster shots' needed to keep immunity strong?

24 Nov 2009

Gilead Sciences and GSK to commercialize Viread in 5 Asian countries

Gilead Sciences, Inc. and GlaxoSmithKline today announced a licensing agreement to commercialize Viread® (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B (HBV) infection in adults in five countries in Asia. The companies’ combined commercialization activities will expand access to Viread for the treatment of HBV, once approved, to patients in Asia where the prevalence in most countries is greater than 8 percent.

24 Nov 2009

NCCN Guidelines adds ofatumumab and romidepsin as therapy options for CLL

Two recent FDA approvals have prompted the National Comprehensive Cancer Network (NCCN) to update the NCCN Clinical Practice Guidelines in Oncology(TM) for Non-Hodgkin's Lymphomas to include ofatumumab (Azerra(TM), GlaxoSmithKline) and romidepsin (Istodax(R), Gloucester Pharmaceuticals) as treatment options for select patients with two types of Non-Hodgkin's Lymphomas.

24 Nov 2009

Drug therapy offers substantial cost savings than angioplasty

Many patients with diabetes should forego angioplasties for heart disease and just take medicine instead, according to a new National Institutes of Health study led by Stanford University School of Medicine researcher Mark Hlatky, MD.

18 Nov 2009

GlaxoSmithKline and bioMerieux to develop predictive test for breast cancer treatments

bioMerieux has signed an agreement with GlaxoSmithKline to develop a predictive test to help clinicians select the most appropriate treatment for different segments of breast cancer patients.

17 Nov 2009

Anacor Pharmaceuticals commences patient dosing in AN3365 Phase I clinical study

Anacor Pharmaceuticals today announced that it has dosed the first patient in a Phase I clinical study for AN3365, a novel boron-based, small-molecule drug candidate in development for the treatment of hospital infections caused by Gram-negative bacteria. The study will evaluate the safety, tolerability and pharmacokinetics of AN3365 in healthy volunteers.

17 Nov 2009

Additional vaccine for 2009 H1N1 flu approved by FDA

The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.

16 Nov 2009

Galapagos third quarter 2009 financial results in line with management expectations

Galapagos NV announces today that third quarter 2009 operational and financial results were in line with management expectations. These results encourage the Company to retain full year guidance of EUR 100 million revenues, a growth of 30% compared to 2008. Galapagos' service division BioFocus will significantly increase its cash contribution to the Group result for the full year 2009.

13 Nov 2009

GSK to donate 50M H1N1 vaccine doses to WHO in coming months

Drugmaker GlaxoSmithKline announced plans on Tuesday to donate 50 million doses of its H1N1 (swine flu) vaccine to the WHO for use in developing countries within the next few months, Reuters reports. "We expect to start receiving [the first of the H1N1 doses] at the end of the month or early December and that the full 50 million will come by the end of spring," WHO spokesman Gregory Hartl said, adding, "We hope it is the first of many donations."

10 Nov 2009

Decision Resources forecasts sales of HER2-targeting agents to grow by 3.3% per year

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in 2008, human epidermal growth factor receptor 2 (HER2) targeting therapies -- which include Roche/Chugai's Herceptin and GlaxoSmithKline/Nippon Kayaku's Tykerb/Tyverb -- were the highest-selling drug class in breast cancer treatment.

9 Nov 2009

Concert Pharmaceuticals commences Phase 1b clinical study of its CTP-518 HIV protease inhibitor

Concert Pharmaceuticals, Inc. announced today that it has initiated a Phase 1b clinical study with CTP-518, its investigational oral HIV protease inhibitor for the treatment of HIV infection. In connection with the start of this multiple ascending dose arm of the Phase 1 study, Concert will receive a $12 million milestone payment under the company’s strategic alliance with GlaxoSmithKline.

9 Nov 2009

FDA extends review date of New Drug Application for GSK1838262/XP13512

GlaxoSmithKline and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. The original PDUFA date for this NDA review was November 9, 2009.

7 Nov 2009

GlaxoSmithKline News and Research

GSK updates long-term survival data of BEXXAR Therapeutic Regimen for Non-Hodgkin's lymphoma

Also in Global Health news: Rotavirus vaccine; guinea worm eradication; health systems; Zulu King calls for male circumcision

Galapagos NV receives milestone payment to initiate Phase I clinical trial of GLPG0555 drug

Scientists report cervarix vaccine offers protection against cervical cancer

GSK places a batch of AS03 adjuvanted H1N1 vaccine on hold

Santaris Pharma's LNA technology based microRNA-targeted therapy holds promise for HCV

UK DFID awards CNTD £10M in elimination of elephantiasis initiative

U.S. H1N1 cases decreasing, CDC says; HHS to review approach to health-threat preparedness

Several new vaccines require booster shots to remain effective during a lifetime: Study

Gilead Sciences and GSK to commercialize Viread in 5 Asian countries

NCCN Guidelines adds ofatumumab and romidepsin as therapy options for CLL

Drug therapy offers substantial cost savings than angioplasty

GlaxoSmithKline and bioMerieux to develop predictive test for breast cancer treatments

Anacor Pharmaceuticals commences patient dosing in AN3365 Phase I clinical study

Additional vaccine for 2009 H1N1 flu approved by FDA

Galapagos third quarter 2009 financial results in line with management expectations

GSK to donate 50M H1N1 vaccine doses to WHO in coming months

Decision Resources forecasts sales of HER2-targeting agents to grow by 3.3% per year

Concert Pharmaceuticals commences Phase 1b clinical study of its CTP-518 HIV protease inhibitor

FDA extends review date of New Drug Application for GSK1838262/XP13512

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