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Pew director issues statement on Prescription Drug User Fee Act hearing

Allan Coukell, director of medical programs for the Pew Health Group, issued the following statement today on a U.S. Senate Health, Education, Labor & Pensions Committee hearing, "FDA User Fees: Advancing Public Health."

29 Jul 2011

New tool can effectively determine likelihood of drugs in the environment

Most synthetic chemical products used in consumer goods end up unchanged in the environment. Given the risks this could pose for the environment and human health, researchers from the Autonomous University of Barcelona (UAB) have developed a new tool to effectively predict what will happen to current and future pharmaceutical products.

29 Jul 2011

Book examines impact of new racial science

In 2005, the Food and Drug Administration approved a drug called BiDil as a therapy for heart failure specifically for African-American patients, claiming in a press release that this was a step toward personalized medicine.

29 Jul 2011

Ivabradine effective in reducing risk of cardiac fibrosis, diastolic heart failure

The findings of a Montreal Heart Institute (MHI) study published in the scientific journal Cardiology suggest that ivabradine, a heart rate reduction medication, is also effective in reducing the risk of diastolic heart failure and cardiac fibrosis.

29 Jul 2011

NIH selects Viamet's novel antifungal compound for inclusion in the TRND program

Viamet Pharmaceuticals, Inc. announced today that one of its novel antifungal compounds has been selected for inclusion in the National Institutes of Health's (NIH) Therapeutics for Rare and Neglected Diseases (TRND) program.

29 Jul 2011

FDA issues Refusal to File letter for Eisai's perampanel NDA to treat partial-onset seizures

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has issued a Refusal to File letter in response to the company's New Drug Application (NDA) for perampanel (E2007), an investigational drug, for the treatment of partial-onset seizures associated with epilepsy which was submitted in May 2011.

29 Jul 2011

BTI's IPOXYN data on traumatic shock and ischemia to be presented at XIIIth MGH symposium

Boston Therapeutics, Inc., a public company registered with the SEC and a developer of diabetes therapeutics, announced today that experiments performed in the laboratory of Massachusetts General Hospital (MGH) faculty member Warren M. Zapol, MD, Emeritus Anesthetist-in-Chief and Director of the MGH Anesthesia Center for Critical Care Research, on BTI's new oxygen carrier for traumatic shock and ischemia, IPOXYNTM, will be presented at the "XIII International Symposium on Blood Substitutes and Oxygen Therapeutics" to be held July 27th-29th at MGH.

29 Jul 2011

Sigma-Tau, Soligenix expand partnership to develop and commercialize orBec in Europe

Soligenix, Inc., a late-stage biopharmaceutical company, announces the expansion and amendment of its North American licensing partnership with Sigma-Tau Pharmaceuticals, Inc. for the development and commercialization of orBec into the European territory.

29 Jul 2011

Oral chicken interferon-alpha may significantly reduce influenza infection

Avian influenza virus is a threat to the commercial chicken industry and, with its recent rapid spread across China, has also shown the ability for transmission from chickens to humans and other mammals.

29 Jul 2011

Yaupon seeks FDA marketing approval of mechlorethamine gel for mycosis fungoides

Yaupon Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its propriety gel formulation of mechlorethamine hydrochloride (mechlorethamine).

28 Jul 2011

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued in October 2010 by the U.S. Food and Drug Administration (FDA) regarding BYDUREON™ (exenatide extended-release for injectable suspension), an investigational medication for type 2 diabetes.

28 Jul 2011

All Canadian provinces except Quebec announce funding agreement for PNH drug, Soliris

L'Association Québécoise de l'HPN regrets that Quebec remains one of the only jurisdictions in the developed world to decline including the only effective life-saving treatment against an ultra-rare blood disease - paroxysmal nocturnal hemoglobinuria (PNH) - on its public drug insurance plan drugs list.

28 Jul 2011

Solazyme launches anti-aging skincare line, Algenist at Space NK stores

Solazyme, Inc., a renewable oil and bioproducts company, has signed a distribution agreement with the United Kingdom's most innovative beauty retailer, Space NK, to expand the sales network of the company's luxury skincare line, Algenist, to include all 60 Space NK stores throughout the country.

28 Jul 2011

Natural recycling system, PPAR agonists can help protect children with heart defects

Children born with heart defects that pummel their lungs with up to three times the normal blood volume quickly find their lungs in jeopardy as well.

28 Jul 2011

Pharmaceutical companies' profit protection hurts global AIDS fight

In her latest piece on the New York Times' "Opinionator" blog, author and journalist Tina Rosenberg argues that the terms of Gilead's recent agreement with the Medicines Patent Pool is "confirmation of a dangerous new trend: middle-income countries as a target market for drug makers."

28 Jul 2011

Smokers are misinformed about safety and efficacy of nicotine replacement therapy

Nearly half of all smokers in the United States attempt to quit at least once per year, yet the majority of these efforts fail. One factor contributing to the low annual rate of successful cessation is that the majority of quit attempts are made without evidence-based treatment such as nicotine replacement therapy.

28 Jul 2011

Dr. Reddy's, FUJIFILM sign MoU to enter partnership in the generic drugs business

FUJIFILM Corporation President and CEO, Shigetaka Komori and Dr. Reddy's Laboratories Ltd. Vice-Chairman and CEO, G V Prasad today signed a Memorandum of Understanding to enter into an exclusive partnership in the generic drugs business for the Japanese market and to establish a joint venture in Japan.

28 Jul 2011

Isis, Genzyme submit European MAA for mipomersen to treat familial hypercholesterolemia

Genzyme, a Sanofi company, and Isis Pharmaceuticals Inc. today announced that Genzyme has submitted a marketing authorization application (MAA) to the European Medicines Agency seeking approval for the 200 mg weekly dose of mipomersen for the treatment of homozygous and severe heterozygous familial hypercholesterolemia.

28 Jul 2011

Watson to acquire portfolio of divested generic pharmaceutical products

Watson Pharmaceuticals, Inc. today announced a definitive agreement to acquire a portfolio of generic pharmaceutical products that are being divested as a result of the merger between Perrigo Company and Paddock Laboratories.

28 Jul 2011

Britain’s prescription drug use statistics revealed

According to latest NHS figures number of prescriptions dispensed has soared by 70 per cent over the last decade. Every man, woman and child in the country received on average 17.8 prescription items in 2010. The vast majority went to those aged over 60, who received 42.4 items each in 2007.

27 Jul 2011

Pharmaceutical News

Pew director issues statement on Prescription Drug User Fee Act hearing

New tool can effectively determine likelihood of drugs in the environment

Book examines impact of new racial science

Ivabradine effective in reducing risk of cardiac fibrosis, diastolic heart failure

NIH selects Viamet's novel antifungal compound for inclusion in the TRND program

FDA issues Refusal to File letter for Eisai's perampanel NDA to treat partial-onset seizures

BTI's IPOXYN data on traumatic shock and ischemia to be presented at XIIIth MGH symposium

Sigma-Tau, Soligenix expand partnership to develop and commercialize orBec in Europe

Oral chicken interferon-alpha may significantly reduce influenza infection

Yaupon seeks FDA marketing approval of mechlorethamine gel for mycosis fungoides

Amylin, Lilly and Alkermes submit reply to FDA complete response letter for BYDUREON

All Canadian provinces except Quebec announce funding agreement for PNH drug, Soliris

Solazyme launches anti-aging skincare line, Algenist at Space NK stores

Natural recycling system, PPAR agonists can help protect children with heart defects

Pharmaceutical companies' profit protection hurts global AIDS fight

Smokers are misinformed about safety and efficacy of nicotine replacement therapy

Dr. Reddy's, FUJIFILM sign MoU to enter partnership in the generic drugs business

Isis, Genzyme submit European MAA for mipomersen to treat familial hypercholesterolemia

Watson to acquire portfolio of divested generic pharmaceutical products

Britain’s prescription drug use statistics revealed

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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