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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

H1N1 is now most dominant flu strain worldwide, WHO says

The H1N1 (swine flu) virus is now the dominant flu strain worldwide, the WHO reported Thursday, with the virus accounting for up to 70 percent of the flu viruses sampled in some countries, the Associated Press reports.

6 Nov 2009

Journal of Infectious Diseases' special edition on rotavirus

The Journal of Infectious Diseases has released a special edition, Global Rotavirus Surveillance: Preparing for the Introduction of Rotavirus Vaccines. This special edition provides a significant contribution to the understanding of rotavirus disease burden and the impact of rotavirus vaccines, which have the potential to save an estimated 228,000 lives annually.

6 Nov 2009

HHS announces contract awards for up to 120,000 treatment courses of intravenous antiviral drugs

The U.S. Department of Health and Human Services (HHS) today announced contract awards for up to 120,000 treatment courses of intravenous (IV) antiviral drugs to help treat hospitalized 2009 H1N1 influenza patients.

6 Nov 2009

Malaria experts discuss eradication at MIM conference

In a session at the 5th Multilateral Initiative on Malaria (MIM) Pan-African Conference in Nairobi, Kenya, experts discussed the tools required to eradicate the disease and highlighted insecticide and drug resistance in some parts of the world, Xinhua reports. Researchers noted that resistance to artemisinin-based combination therapies (ACTs) has been documented in western Cambodia and "has now also been reported in the west of Thailand and in eastern Myanmar," the news service writes (Ooko/Zhuoyun, 11/5).

6 Nov 2009

Third-quarter financial results for the year 2009 announced by Biovail

Biovail Corporation today announced financial results for the three-month and nine-month periods ended September 30, 2009. To the extent that this news release contains forward-looking statements, investors are cautioned that these statements are based on the Company’s current views, and actual outcomes are not certain.

5 Nov 2009

News outlets examine international efforts to contain H1N1

A WHO official on Tuesday backed the Afghan government's decision to declare H1N1 (swine flu) a health emergency, forcing the closure of all schools in the country for three weeks in an effort to contain the virus, IRIN reports.

4 Nov 2009

AMFm subsidized malaria drugs to be delivered soon

Subsidized artemisinin-based combination therapies (ACTs) under the Affordable Medicines Facility - malaria (AMFm) program will be available in select countries "in two week's time," SABC News reports. The announcement came Monday at the 5th Multilateral Initiative on Malaria (MIM) Pan-African Conference in Nairobi, Kenya.

4 Nov 2009

GSK's malaria vaccine trial containing Antigenics’ Stimulon adjuvant enrolls more than 5,000 children

Antigenics, Inc. today indicated that GlaxoSmithKline’s (GSK) Phase III malaria vaccine clinical trial, containing Antigenics’ QS-21 Stimulon® adjuvant, has enrolled more than 5,000 children to date and is expected to involve up to 16,000 children. The pivotal efficacy study of RTS,S, the world’s most clinically advanced malaria vaccine, is ongoing in seven African countries.

4 Nov 2009

Third quarter 2009 financial results announced by Synta Pharmaceuticals

Synta Pharmaceuticals Corp., a biopharmaceutical company focused on discovering, developing, and commercializing small molecule drugs to treat severe medical conditions, today reported financial results for the quarter ended September 30, 2009.

4 Nov 2009

New strategy to eliminate and eradicate malaria unveiled

Marking its tenth anniversary year, the PATH Malaria Vaccine Initiative (MVI) today unveiled a new strategy that sets the stage for an aggressive push targeting the long-term goal of eliminating and eradicating malaria

4 Nov 2009

GlaxoSmithKline News and Research

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

H1N1 is now most dominant flu strain worldwide, WHO says

Journal of Infectious Diseases' special edition on rotavirus

HHS announces contract awards for up to 120,000 treatment courses of intravenous antiviral drugs

Malaria experts discuss eradication at MIM conference

Third-quarter financial results for the year 2009 announced by Biovail

News outlets examine international efforts to contain H1N1

AMFm subsidized malaria drugs to be delivered soon

GSK's malaria vaccine trial containing Antigenics’ Stimulon adjuvant enrolls more than 5,000 children

Third quarter 2009 financial results announced by Synta Pharmaceuticals

New strategy to eliminate and eradicate malaria unveiled

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