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Physicians urge FDA not to approve Truvada as an HIV prevention pill

Last week, a group of 55 U.S. physicians sent a letter to the U.S. Food & Drug Administration (FDA), urging the agency not to approve the use of Gilead's HIV/AIDS treatment drug Truvada for use as an HIV prevention pill - also known as "pre-exposure prophylaxis" (PrEP).

30 Jun 2011

Early metformin treatment may prevent adolescent polycystic ovary syndrome

A recent study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM) found that early, prolonged treatment with the diabetes drug metformin may prevent or delay the development of polycystic ovary syndrome (PCOS) in adolescence.

30 Jun 2011

FDA's ODAC recommends withdrawal of Avastin approval for metastatic breast cancer

Genentech, a member of the Roche Group, announced today that, during a U.S. Food and Drug Administration (FDA) hearing, the FDA's Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin in combination with paclitaxel chemotherapy for previously untreated HER2-negative metastatic breast cancer.

30 Jun 2011

Dendreon receives FDA approval for Los Angeles cancer immunotherapy manufacturing facility

Dendreon Corporation today announced that the U.S. Food and Drug Administration approved its Los Angeles cancer immunotherapy manufacturing facility, allowing the company to continue to increase the availability of PROVENGE across the U.S. to help meet the needs of patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.

30 Jun 2011

Viewpoints: Calif.'s budget, Supreme Court drug rulings, the Avastin debate

The budget is not realistic, counting on fantastical revenue projections as well as a redevelopment gambit that's likely to be blocked in court. It makes deep cuts in state programs that will have unwelcome repercussions in years to come. And if the revenue projections prove to be as overly optimistic as they seem, there will be more damaging cuts to education, child care and health services. Nevertheless, it's a more earnest effort to clean up the state's budget mess than Sacramento has seen in a decade or more.

30 Jun 2011

Supreme Court rules in favor of ‘pharma’ data mining

The U.S. Supreme Court ruled that the pharmaceutical companies could use the information that they gained from doctors’ prescribing records. The data mining had been restricted in Maine following the high court ruling that struck down a similar law in Vermont.

29 Jun 2011

Vaccines may be given in food in the near future

Soon children could be vaccinated with bacteria mixed in milk and people in the developing world given unprecedented access to immunisations under a scheme proposed by an Australian Nobel laureate, Barry Marshall.

29 Jun 2011

FDA looks at Avastin risks

The US Food and Drug Administration is holding a two-day hearing that pits the FDA's Center for Drug Evaluation and Research against Genentech, that manufactures breast cancer drug Avastin. A handful of breast cancer patients testified Tuesday that Avastin helped in treating their metastatic breast cancer but a review of studies conducted by the FDA's Center for Drug Evaluation and Research suggests the risks outweigh the benefits of Avastin for treating breast cancer, FDA officials said at the hearing.

29 Jun 2011

Patients, scientists in different corners for cancer drug fight

The drug, Avastin, will be the subject of an unusual Food and Drug Administration hearing to revisit a panel vote last July that steered many doctors away from prescribing the drug for the treatment of breast cancer.

29 Jun 2011

Exciton enters distribution agreement with Marathon Medical

Exciton Technologies Inc. today announced the Company has signed a distribution agreement with Marathon Medical, adding them to the existing Federal Supply Schedule (FSS) contract, administered by the Department of Veterans Affairs on behalf of the U.S. General Services Administration (GSA), effective July 1st.

29 Jun 2011

Cipher grants Vertical exclusive U.S. distribution rights to CIP-TRAMADOL ER

Cipher Pharmaceuticals Inc. today announced that it has entered into a definitive distribution and supply agreement with Vertical Pharmaceuticals, Inc., a U.S.-based specialty pharmaceutical company, under which Cipher has granted Vertical the exclusive right to market, sell and distribute CIP-TRAMADOL ER in the United States.

29 Jun 2011

Suneva Medical receives Health Canada marketing approval for Bellafill

Suneva Medical, a privately-held aesthetic medical device company, today announced the expansion of its core aesthetics injectable business with approval from Health Canada to market Bellafill™, its long lasting dermal filler for nasolabial folds or smile line correction.

29 Jun 2011

Hi-Tech Pharmacal pays $3.6M for rights to Atley's branded pain treatment products

Hi-Tech Pharmacal Co., Inc., a specialty pharmaceuticals company, announced today that they acquired marketing and distribution rights to several unique branded products for the treatment of pain from Atley Pharmaceuticals. Some products are approved and some are pending approval with the Food and Drug Administration (FDA).

29 Jun 2011

Medivir, Meda renegotiate agreement for cold sores medicine, Xerese

Medivir AB, the emerging research-based specialty pharmaceutical company focused on infectious diseases, today announced that it has renegotiated the terms of its commercial partnership with Meda for Xerese, its unique marketed product for cold sores (herpes labialis).

29 Jun 2011

Study proves efficacy of cellulose powder, without any adverse effects, in treatment of hay fever for children

A cellulose powder has been used increasingly for many years against allergic rhinitis. Still, there has been a shortage of scientific evidence for its efficacy in seasonal allergic rhinitis (hay fever), particularly in children. Now, however, scientists from the Sahlgrenska Academy and the Department of Plant and Environmental Sciences at the University of Gothenburg have proven that the cellulose powder reduces symptoms of seasonal allergic rhinitis in children, without any adverse effects.

29 Jun 2011

Bayer Yakuhin seeks marketing authorization in Japan for EYLEA for treatment of wet AMD

Regeneron Pharmaceuticals, Inc. and Bayer HealthCare announced that Bayer Yakuhin, Ltd., Osaka, Japan, has submitted an application to the Ministry of Health, Labor and Welfare (MHLW) in Japan for marketing authorization for EYLEA, also known as VEGF Trap-Eye, for the treatment of the neovascular form of age-related macular degeneration (wet AMD).

29 Jun 2011

Bristol-Myers Squibb and Mylan expand access to HIV drug Reyataz in sub-Saharan Africa and India

Bristol-Myers Squibb Company today announced a new agreement to expand access to Reyataz (atazanavir sulfate). The immunity-from-suit agreement signed with Matrix Laboratories Limited, a Mylan Company, enables the generic company to manufacture and sell atazanavir, as well as stavudine and didanosine, in sub-Saharan Africa and India.

29 Jun 2011

Bio-Nucleonics' generic Metastron, an option for metastatic cancer bone pain therapy

Bio-Nucleonics' lead product Strontium Chloride Sr-89 Injection USP (Strontium-89), which is the generic version of Metastron®, is an option to consider for metastatic cancer bone pain therapy, typically caused by advanced stage breast, prostate or lung cancer.

28 Jun 2011

Tibotec, Gilead Sciences enter license agreement for new combination product of PREZISTA and cobicistat

Tibotec Pharmaceuticals today announced that it has entered into a license agreement with Gilead Sciences, Inc., for the development and commercialization of a new once-daily single tablet fixed-dose antiretroviral combination product containing Tibotec's protease inhibitor PREZISTA® (darunavir) and Gilead's cobicistat, an investigational pharmacoenhancing or "boosting" agent.

28 Jun 2011

Merck, UPS extend logistics and distribution agreement

UPS and Merck, known as MSD outside the United States and Canada, today announced that the companies have significantly broadened their existing distribution and logistics agreement to include aspects of Merck's global supply chain around the world.

28 Jun 2011

Pharmaceutical News

Physicians urge FDA not to approve Truvada as an HIV prevention pill

Early metformin treatment may prevent adolescent polycystic ovary syndrome

FDA's ODAC recommends withdrawal of Avastin approval for metastatic breast cancer

Dendreon receives FDA approval for Los Angeles cancer immunotherapy manufacturing facility

Viewpoints: Calif.'s budget, Supreme Court drug rulings, the Avastin debate

Supreme Court rules in favor of ‘pharma’ data mining

Vaccines may be given in food in the near future

FDA looks at Avastin risks

Patients, scientists in different corners for cancer drug fight

Exciton enters distribution agreement with Marathon Medical

Cipher grants Vertical exclusive U.S. distribution rights to CIP-TRAMADOL ER

Suneva Medical receives Health Canada marketing approval for Bellafill

Hi-Tech Pharmacal pays $3.6M for rights to Atley's branded pain treatment products

Medivir, Meda renegotiate agreement for cold sores medicine, Xerese

Study proves efficacy of cellulose powder, without any adverse effects, in treatment of hay fever for children

Bayer Yakuhin seeks marketing authorization in Japan for EYLEA for treatment of wet AMD

Bristol-Myers Squibb and Mylan expand access to HIV drug Reyataz in sub-Saharan Africa and India

Bio-Nucleonics' generic Metastron, an option for metastatic cancer bone pain therapy

Tibotec, Gilead Sciences enter license agreement for new combination product of PREZISTA and cobicistat

Merck, UPS extend logistics and distribution agreement

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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