Pharmaceuticals News and Research

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Controversy around Merck's pricing for its AIDS drug Isentress

The controversy around Merck and Co. Pharmaceuticals’ pricing for its key AIDS drug Isentress — at nearly $13,000 per patient yearly, the most expensive first line AIDS therapy on the US market today — continued this week following Merck’s reaction to recent public criticism of its AIDS drug pricing. Merck ramped up its damage control PR efforts, issuing a press release that sought to rewrite the history of Isentress and deflect attention by claiming AIDS Healthcare Foundation has been unfairly attacking them.

22 Jan 2010

Apotex provides nearly $2M worth of medicines for Haiti relief efforts

Apotex Inc, the largest Canadian-owned pharmaceutical company, is working with the following relief organizations: World Vision, Feed the Children, and One X One. The company has provided close to $2 million worth of medicines to assist with the healthcare needs of the Haitian population.

22 Jan 2010

PCMA releases statement on new legislation introduced by Congressman Stephen F. Lynch

The Pharmaceutical Care Management Association (PCMA) released the following statement today on new legislation introduced by Congressman Stephen F. Lynch (D-Mass.) — the FEHBP Prescription Drug Integrity, Transparency, and Cost Savings Act (H.R. 4489) — which would increase prescription drug costs and reduce choices for federal employees

22 Jan 2010

Heilongjiang Tianlong Pharmaceutical changes R&D focus to antibiotics and cardiac drugs

China Sky One Medical, Inc., a leading fully integrated pharmaceutical company developing and producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that Heilongjiang Tianlong Pharmaceutical Company ("Tianlong"), the Company's wholly owned subsidiary, will change its R&D focus from external use medicines to antibiotics and cardiac drugs.

22 Jan 2010

Watson Pharmaceuticals provides detailed overview of its global operations at Investor Day meeting in NY

Watson Pharmaceuticals, Inc. today provided a detailed overview of its expanded global operations, enhanced supply chain capabilities and commercial and pipeline developments in its Brand and Generics businesses during an Investor Day meeting held in New York, NY.

22 Jan 2010

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Somaxon Pharmaceuticals, Inc., a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, today provided an update on the status of its New Drug Application (NDA) for Silenor® (doxepin) for the treatment of insomnia.

22 Jan 2010

Thomas S. Kilduff named a Fellow of the AAAS

SRI International, an independent nonprofit research and development institute, announced today that Thomas S. Kilduff, Ph.D., director of SRI International's Center for Neuroscience, has been named a Fellow of the American Association for the Advancement of Science (AAAS).

22 Jan 2010

Gamma Pharmaceuticals signs Distribution Agreement for its branded product ranges

Gamma Pharmaceuticals Inc. announced today that the Company has signed a Distribution Agreement for Gamma's branded product ranges. Under the Distribution Agreement, Gamma's monthly sales will ramp-up to $3.4 million.

21 Jan 2010

Scientific/technical review for XIAFLEX' European MAA commences

BioSpecifics Technologies Corp., a biopharmaceutical company developing first in class collagenase-based products, today announced that its partner Auxilium Pharmaceuticals, Inc. announced that Pfizer Inc. received notification from the European Medicines Agency that the Marketing and Authorization Application (MAA) for XIAFLEX™ for the treatment of Dupuytren's disease (a debilitating disorder resulting from excessive collagen deposition that causes contractures of the fingers) has completed the validation phase successfully and that the scientific/technical review procedure commenced today.

21 Jan 2010

Teva Pharmaceutical Industries receives FDA tentative approval for generic Femara Tablets

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis’ breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg. Final approval of Teva’s Letrozole Tablets is expected upon expiry of patent protection for the brand product in June 2011.

21 Jan 2010

US FDA grants tentative approval for LPI's Memantine HCl tablets

Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval from the US Food and Drug Administration (US FDA) for its Memantine Hydrochloride tablets, 5mg and 10mg.

21 Jan 2010

Reuters examines chronic disease in developing countries, future of drug prices

"Global health projections leave little doubt that chronic diseases are rapidly overtaking infectious diseases, such as malaria, AIDS and tuberculosis (TB), as the world's biggest killers - a shift emphasized by a recent World Health Organization (WHO) report on global health risks," Reuters writes in a story analyzing the future of drug pricing in the developing world. Longer life-spans in developing countries "and changing patterns of food, alcohol and tobacco consumption are creating a 'double burden' for poor nations, piling chronic diseases on top of infectious diseases," the news service writes.

21 Jan 2010

MDRNA to receive European patent for its intranasal insulin formulation

MDRNA, Inc., a leading RNAi-based drug discovery and development company, today announced that the European Patent Office intends to grant a patent for application EP06826368 covering formulations for the intranasal delivery of rapid acting insulin, and its use for the treatment of diabetes.

21 Jan 2010

Phase Forward releases Empirica Signal version 7.2 signal detection and management software

Phase Forward, a leading provider of data solutions for clinical trials and drug safety, today announced the availability of version 7.2 of its Empirica™ Signal product, a significant new release of the company’s flagship signal detection and management software. The Empirica Signal solution is a state-of-the-art data mining and knowledge management tool and a cornerstone component of Phase Forward’s Empirica Suite of pharmacovigilance and risk management products.

21 Jan 2010

Ipsen and Inspiration Biopharmaceuticals form strategic partnership

Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today announced the formation of a strategic partnership between Ipsen and Inspiration Biopharmaceuticals ("Inspiration") to create a world leading hemophilia franchise, an important milestone for the Celtic Pharma portfolio.

21 Jan 2010

Symbollon Pharmaceuticals to launch IoGen women's breast health dietary supplement in February

Symbollon Pharmaceuticals, Inc. has announced today that the retail launch of IoGen™, its dietary supplement for women's breast health, will commence in February. IoGen™ is the first dietary supplement formulated to promote breast health for women. Initially, the Company plans to market IoGen™ through its own retail web site, which is currently being developed by Atech Solutions.

21 Jan 2010

China Pharma Holdings announces completion of clinical trials for Candesartan

China Pharma Holdings, Inc., which develops, manufactures, and markets specialty pharmaceutical products in China, today announced that the Company has completed clinical trials for Candesartan, an anti-hypertension drug, and submitted the generic drug production application to the SFDA.

21 Jan 2010

Elevation Pharmaceuticals closes $30M tranched Series A financing

Elevation Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new aerosol therapies for patients with respiratory diseases, announced today the closing of a $30 million tranched Series A financing.

21 Jan 2010

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

BioNumerik Pharmaceuticals, Inc. today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer.

21 Jan 2010

Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

Pfizer Inc. and Auxilium Pharmaceuticals, Inc. today announced that Pfizer received notification from the European Medicines Agency that the Marketing Authorization Application (MAA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, biologic for the treatment of Dupuytren’s contracture (a condition resulting in the contracture of the fingers into the palm), has completed the validation phase successfully. As a result, the scientific/technical review procedure commenced on 21 January 2010.

21 Jan 2010

Pharmaceuticals News and Research

Controversy around Merck's pricing for its AIDS drug Isentress

Apotex provides nearly $2M worth of medicines for Haiti relief efforts

PCMA releases statement on new legislation introduced by Congressman Stephen F. Lynch

Heilongjiang Tianlong Pharmaceutical changes R&D focus to antibiotics and cardiac drugs

Watson Pharmaceuticals provides detailed overview of its global operations at Investor Day meeting in NY

Update on the status of Somaxon Pharmaceuticals' NDA for Silenor provided

Thomas S. Kilduff named a Fellow of the AAAS

Gamma Pharmaceuticals signs Distribution Agreement for its branded product ranges

Scientific/technical review for XIAFLEX' European MAA commences

Teva Pharmaceutical Industries receives FDA tentative approval for generic Femara Tablets

US FDA grants tentative approval for LPI's Memantine HCl tablets

Reuters examines chronic disease in developing countries, future of drug prices

MDRNA to receive European patent for its intranasal insulin formulation

Phase Forward releases Empirica Signal version 7.2 signal detection and management software

Ipsen and Inspiration Biopharmaceuticals form strategic partnership

Symbollon Pharmaceuticals to launch IoGen women's breast health dietary supplement in February

China Pharma Holdings announces completion of clinical trials for Candesartan

Elevation Pharmaceuticals closes $30M tranched Series A financing

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

Pfizer and Auxilium Pharmaceuticals announce completion of European MAA validation phase for XIAFLEX

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