Pharmaceuticals News and Research

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First Edition: June 25, 2010

Today's headlines reflect the latest news about the House passing a temporary ban on cuts in Medicare reimbursements to doctors, while Senate Democrats failed to gain approval for their jobs bill, which included enhanced Medicaid aid to states.

25 Jun 2010

Investment report on Somaxon Pharmaceuticals

MicroStockProfit.com announces an investment report featuring Somaxon Pharmaceuticals Inc. The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.

25 Jun 2010

PMPRB report: Brand-name drug companies in Canada spent only 7.5% of revenues on R&D in 2009

Research and development spending in Canada by brand-name drug companies has dropped to its lowest level in 20 years, according to the latest annual report of the Patented Medicine Prices Review Board.

25 Jun 2010

JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration's Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010.

25 Jun 2010

Mylan granted final FDA approval for Procardia XL Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Nifedipine Extended-release Tablets USP, 30 mg, 60 mg and 90 mg, the generic version of Pfizer's Procardia XL® Tablets, a treatment for angina and/or hypertension.

25 Jun 2010

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

Quark Pharmaceuticals, Inc., a world leader in the discovery and development of RNAi-based therapeutics, today announced that two of its siRNA drug candidates were featured in the following two presentations at the Glaucoma & Retinopathies 2010 conference, which was held June 21-22, 2010 in London, UK.

25 Jun 2010

University of Michigan professor recognised with PHA Award of Excellence

The Pulmonary Hypertension Association (PHA) and Actelion Pharmaceuticals US, Inc., today announced Dr. Vallerie McLaughlin of the University of Michigan Health System as the recipient of the annual PHA Award of Excellence in Pulmonary Arterial Hypertension (PAH) Care. As part of the award, the University of Michigan System will receive a grant in the amount of $50,000 to support continued excellence in care for patients with PAH.

24 Jun 2010

MonoSol Rx, Midatech collaborate to develop peptides for therapeutic delivery utilizing pharmaceutical films

MonoSol Rx, the developer of PharmFilm® drug delivery technology, today announced the expansion of its agreement with Midatech Group (Oxford, UK) to develop nanoparticle-based proteins and peptides for therapeutic delivery utilizing pharmaceutical films. Under the terms of the expanded agreement, MonoSol Rx has made an equity investment in Midatech and Keith Kendall, Executive Vice President and Chief Financial Officer of MonoSol Rx, will join the Midatech Board of Directors.

24 Jun 2010

MDS Nordion, Guerbet, Cyceron collaborate to develop new PET radiotracers for cancer diagnostics

MDS Nordion, a leading provider of products and services to the global health science market, Guerbet, a pharmaceutical group specialized in medical imaging, and Cyceron, a biomedical imaging centre in France, announced today they have entered into an agreement to develop new Positron Emission Tomography (PET) radiotracers for cancer diagnostics.

24 Jun 2010

Infinity commences enrollment in IPI-493 Phase 1 clinical trial for advanced hematologic malignancies

Infinity Pharmaceuticals, Inc., an innovative drug discovery and development company, today announced that patients are being enrolled in a Phase 1 clinical trial evaluating IPI-493 in patients with advanced hematologic malignancies. This multi-center study is the second clinical trial of IPI-493, Infinity's oral heat shock protein 90 (Hsp90) chaperone inhibitor.

24 Jun 2010

Blood flow disturbances in artery determine appearance of atherosclerosis: Study

A new animal model of atherosclerosis has allowed researchers to identify a host of genes turned on or off during the initial stages of the process, before a plaque appears in the affected blood vessel.

24 Jun 2010

USPTO confirms validity of DUSA's key Levulan PDT patent

DUSA Pharmaceuticals, Inc.®, a dermatology company that is developing and marketing Levulan® Photodynamic Therapy (PDT), today announced that the United States Patent and Trademark Office (USPTO) has completed its re-examination of US Patent No. 5,079,262, "Method of detection and treatment of malignant and non-malignant lesions utilizing 5-aminolevulinic acid."

24 Jun 2010

FDA grants t2cure orphan drug designation for t2c001 in Buerger's Disease

t2cure GmbH, a biopharmaceutical company developing and marketing stem cell-based regenerative therapies, announced today that the FDA has granted orphan drug designation to t2c001 for the treatment of Buerger's Disease. The Company also announced that in a concurrent application in Europe the EMA's Committee for Orphan Medicinal Products recently recommended t2c001 for orphan designation to the European Commission.

24 Jun 2010

AVEO receives EMA orphan medicinal product designation for tivozanib

AVEO Pharmaceuticals, Inc., a biopharmaceutical company focused on discovering, developing and commercializing cancer therapeutics, today announced it has received orphan medicinal product designation for tivozanib (N-{2-chloro-4-[(6,7-dimethoxy-4-quinolyl)oxy]phenyl}-N'-(5-methyl-3-isoxazolyl) urea hydrochloride monohydrate), its oral, triple VEGF receptor inhibitor, for the treatment of renal cell carcinoma by the European Medicines Agency (EMA).

24 Jun 2010

Increased drug development cost drives pharma companies to seek better opportunities in emerging markets

The increased cost of drug development has impelled pharmaceutical companies to seek better opportunities in emerging markets to successfully expand and sell their products. Most pharmaceutical companies consider emerging markets lucrative due to their economical infrastructure and manpower costs and a significant untapped market potential with a large population.

24 Jun 2010

Alnylam presents data on novel delivery lipids at IBC 6th Annual Cell Line Development and Engineering conference

Alnylam Biotherapeutics, a division of Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today the presentation of new data at the IBC 6th Annual Cell Line Development and Engineering conference held in San Francisco, California from June 21 - 24, 2010.

24 Jun 2010

Washington personalities: Lobbyist Tauzin shakes it up; More on OMB director's impending departure

Roll Call: Billy Tauzin, the former Louisiana lawmaker, will leave his job as the president of the Pharmaceutical Research and Manufacturers of America next Wednesday, and part ways -- for the first time in 18 years -- with his trusty communications director, Ken Johnson. As Roll Call puts it, "The sun is setting on a K Street bromance." Tauzin is likely to start a lobbying firm with his son Tom or practice law in Texas, while Johnson will pursue other work. The two were said to be "attached at the hip" (Murray, 6/23).

24 Jun 2010

Spherix to explore triglycerides for D-tagatose therapy

Spherix Incorporated, an innovator in biotechnology for diabetes therapy, and a provider of technical and regulatory consulting services to food, supplement, biotechnology and pharmaceutical companies, today announced that it will explore triglycerides as a potential therapeutic opportunity for its D-tagatose therapy, pending a review of data from a Phase 3 clinical trial the Company is conducting on the use of D-tagatose as a treatment for Type 2 diabetes.

24 Jun 2010

MSD enters collaboration with Adcock Ingram to co-promote, distribute products in South Africa

Merck (Merck is known as MSD outside the United States and Canada) today announced a strategic collaboration between MSD South Africa and Adcock Ingram, a publicly held South African company, to co-promote and distribute a number of established MSD products in South Africa. The products that will be jointly promoted by MSD and Adcock Ingram include over-the-counter (OTC) products and selected prescription medicines currently registered in South Africa by MSD and Schering-Plough.

24 Jun 2010

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 to review the Company's New Drug Application (NDA) for Contrave® (naltrexone sustained release (SR)/bupropion SR) for the treatment of obesity.

24 Jun 2010

Pharmaceuticals News and Research

First Edition: June 25, 2010

Investment report on Somaxon Pharmaceuticals

PMPRB report: Brand-name drug companies in Canada spent only 7.5% of revenues on R&D in 2009

JZP-6 to be reviewed at joint meeting for treatment of fibromyalgia

Mylan granted final FDA approval for Procardia XL Tablets

Quark Pharmaceuticals' siRNA drug candidates featured in two presentations at Glaucoma & Retinopathies 2010

University of Michigan professor recognised with PHA Award of Excellence

MonoSol Rx, Midatech collaborate to develop peptides for therapeutic delivery utilizing pharmaceutical films

MDS Nordion, Guerbet, Cyceron collaborate to develop new PET radiotracers for cancer diagnostics

Infinity commences enrollment in IPI-493 Phase 1 clinical trial for advanced hematologic malignancies

Blood flow disturbances in artery determine appearance of atherosclerosis: Study

USPTO confirms validity of DUSA's key Levulan PDT patent

FDA grants t2cure orphan drug designation for t2c001 in Buerger's Disease

AVEO receives EMA orphan medicinal product designation for tivozanib

Increased drug development cost drives pharma companies to seek better opportunities in emerging markets

Alnylam presents data on novel delivery lipids at IBC 6th Annual Cell Line Development and Engineering conference

Washington personalities: Lobbyist Tauzin shakes it up; More on OMB director's impending departure

Spherix to explore triglycerides for D-tagatose therapy

MSD enters collaboration with Adcock Ingram to co-promote, distribute products in South Africa

FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

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