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Afinitor plus BSC doubles progression-free survival in patients with advanced pancreatic neuroendocrine tumors

The New England Journal of Medicine (NEJM) published a study today that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET).

10 Feb 2011

Triad alcohol prep pads with ARIXTRA Starter Kits not to be used

GlaxoSmithKline (GSK) has become aware of a United States market recall of all lots of alcohol prep pads, swabs and swabsticks manufactured by the Triad Group and marketed under various brand names. The Triad Group recall has been initiated due to concerns about potential microbial contamination of the alcohol products with Bacillus cereus that could potentially lead to life-threatening infections.

25 Jan 2011

VIVUS holds End-of-Review meeting with FDA for QNEXA NDA

VIVUS, Inc. today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational drug for the treatment of obesity. The meeting occurred on January 19th at the FDA's offices in Maryland and was attended by senior members of the FDA and VIVUS' management and consultants.

21 Jan 2011

Study: HIV-positive head and neck cancer patients respond well to radiation therapy treatments

HIV-positive head and neck cancer patients respond well to radiation therapy treatments and experience similar toxicity rates as non-HIV-positive patients, despite prior reports to the contrary, according to a study in the January issue of the International Journal of Radiation Oncology•Biology•Physics, an official journal of the American Society for Radiation Oncology.

19 Jan 2011

American Heart Association honors SBUMC with Get With The Guidelines-Stroke Gold Plus Performance Achievement Award

Stony Brook University Medical Center has received the 2009 American Heart Association/American Stroke Association's Get With The Guidelines Stroke Gold Plus Performance Achievement Award.

18 Jan 2011

Medical aid workers should take pre-travel precautions to prevent disease transmission

Guidance about pre-travel precautions and preventive measures are highlighted in the December 1, 2010 issue of Clinical Infectious Diseases, written by clinicians and researchers at the Uniformed Services University of the Health Sciences and their partners from the University of Texas Health Sciences Center, Naval Medical Research Center and others.

11 Jan 2011

NovaDel receives $500,000 milestone payment from Akrimax in connection with NitroMist agreement

NovaDel Pharma Inc. today announced that it has received a $500,000 milestone payment from Akrimax Pharmaceuticals. The milestone payment was received in connection with the license and distribution agreement, dated October 27, 2009, between NovaDel Pharma Inc. and Mist Acquisition, LLC, an affiliate of Akrimax Pharmaceuticals.

7 Jan 2011

FDA approves Impax's ANDA for generic Doryx 75 and 100mg tablets

Impax Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted final approval of the Company's Abbreviated New Drug Application for the generic version of Doryx® (doxycyline hyclate delayed-release) 75 and 100mg tablets. The Company is preparing for product launch through Global Pharmaceuticals, Impax's generic division.

29 Dec 2010

LFB receives positive review feedback for closing of Willfact 1000 IU Mutual Recognition Procedure

LFB received from the German regulatory authority (Paul-Ehrlich-Institute) a positive review feedback for the closing of the Mutual Recognition Procedure (MRP) of Willfact® 1000 IU with Germany as the reference member state.

22 Dec 2010

Country must make wise choices in preventing infections, says study on future of AIDS in Cambodia

Despite Cambodia's remarkable history in driving down HIV infections, a report released today on the future of AIDS in the country argues that future success is not guaranteed and the government needs to focus increasingly on wise prevention tactics and assume more of the financing of its AIDS program.

21 Dec 2010

Silence provides year-end update on trading and offer-period

Silence Therapeutics plc, a leading global biotechnology company dedicated to the discovery, development and delivery of targeted, systemic RNA interference (RNAi) therapeutics for the treatment of serious diseases, today provides a year-end update on trading and the offer-period.

21 Dec 2010

U.S., South Africa sign PEPFAR partnership agreement

Secretary of State Hillary Rodham Clinton and South African International Relations and Cooperation Minister Maite Nkoana-Mashabane on Tuesday signed a "partnership agreement that will guide efforts on fighting HIV/AIDS in the African nation," Bloomberg BusinessWeek reports (Wessels, 12/15).

17 Dec 2010

DARPA awards Pulmatrix $5.7 million grant to advance iCALM therapies

Pulmatrix, a clinical stage biotechnology company discovering and developing a new class of therapies for the prevention, treatment and control of respiratory diseases, today announced that it has been awarded a grant for $5.7 million from the Defense Advanced Research Projects Agency (DARPA), a component of the Department of Defense (DOD), focused on identifying and advancing novel technologies to support defense of our nation's soldiers and civilian population.

14 Dec 2010

Everolimus plus tamoxifen delays disease progression in HR+/HER2- metastatic breast cancer

A new study shows that the addition of everolimus (Afinitor® tablets) to the hormonal therapy tamoxifen in patients with hormone-receptor positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer who have been previously treated with an aromatase inhibitor (AI) delays disease progression compared to tamoxifen alone. These results were presented today at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium in San Antonio, Texas.

10 Dec 2010

AJPH publishes study on importance of preventive dental treatment for pregnant women

Aetna today announced that the study, An Examination of Periodontal Treatment, Dental Care and Pregnancy Outcomes in an Insured Population, has been published online by the American Journal of Public Health.

9 Dec 2010

Three abstracts on Defibrotide presented at ASH Annual Meeting

Gentium S.p.A. today announced that three abstracts on Defibrotide were presented at the 52nd Annual Meeting and Exposition of the American Society of Hematology held at the Orange County Convention Center in Orlando, Florida, December 4-7, 2010.

8 Dec 2010

Idis to manage ViroPharma's named patient program

ViroPharma Incorporated and Idis, the global leader in developing long-term strategic solutions to therapeutic access, today announced that the two companies have partnered to facilitate access to certain ViroPharma products through a named patient program (NPP). ViroPharma's NPP, developed and managed by Idis, will allow international healthcare professionals to prescribe certain products to individual patients until the time that approval is sought in local countries.

7 Dec 2010

First patient dosed with rFVIIIFc in A-LONG trial

Biogen Idec and Swedish Orphan Biovitrum today announced that the first patient has been dosed with the companies' long-lasting recombinant Factor VIII Fc fusion protein (rFVIIIFc) in a global registrational clinical trial. The study, called A-LONG, is an open-label, multicenter, Phase 2/3 study designed to evaluate the safety, pharmacokinetics and efficacy of rFVIIIFc in previously-treated hemophilia A patients.

6 Dec 2010

Investigational study data of REVLIMID with rituximab or rituximab-containing regimen in CLL patients presented at ASH

Celgene International Sàrl announced that clinical data from two investigational studies evaluating the use of REVLIMID (lenalidomide) either with rituximab or following a rituximab-containing regimen in patients with chronic lymphocytic leukaemia were presented at the 52nd American Society of Hematology annual meeting.