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Einstein scientists awarded $4.1M to test microbicide Carraguard against HPV

The National Cancer Institute has awarded Albert Einstein College of Medicine of Yeshiva University $4.1 million to test the microbicide Carraguard- against the human papillomavirus, which causes cervical cancer. The research will evaluate the efficacy of Carraguard- - a clear gel made from the seaweed derivative carrageenan - in preventing new HPV infections in women.

26 Jul 2010

First generic version of Lovenox receives FDA approval for DVT

The U.S. Food and Drug Administration today approved the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant drug used to prevent deep vein thrombosis, a potentially deadly blood clotting condition.

23 Jul 2010

China Sky One Medical receives SFDA approval for producing Ciclopirox Olamine Vaginal Suppositories

China Sky One Medical, Inc., a leading fully integrated pharmaceutical company in the People's Republic of China, today announced that the Company has obtained approval from the State Food and Drug Administration in China for the production of Ciclopirox Olamine Vaginal Suppositories.

23 Jul 2010

Taiho Pharmaceutical receives approval to market ABRAXANE IV Infusion 100 mg in Japan

Abraxis BioScience, Inc., a fully integrated, global biotechnology company, today announced that Taiho Pharmaceutical Co., Ltd. has received approval from the Ministry of Health, Labor and Welfare to market ABRAXANE IV Infusion 100 mg, Paclitaxel Injection (Suspension with Albumin), for use in the treatment of breast cancer. The New Drug Application (J-NDA) for ABRAXANE was filed with the Ministry of Health, Labor and Welfare in 2008.

23 Jul 2010

Preclinical data of new acamprosate prodrug to be presented at International Fragile X Conference

XenoPort, Inc. announced today that it has discovered a novel prodrug that has the potential to improve significantly the blood concentration of acamprosate compared with the currently approved formulation of acamprosate. Preclinical data on this new product candidate will be presented tomorrow at the National Fragile X Foundation's 12th International Fragile X Conference in Detroit, Michigan.

23 Jul 2010

Titan anticipates second-quarter Fanapt royalty payment of $55,000

Titan Pharmaceuticals, Inc. today reported that the company expects to receive a royalty payment of approximately $55,000 on second quarter 2010 sales of Fanapt (iloperidone) of approximately $693,000. This reflects a significant decrease from first quarter sales which, as is customary, included substantial initial product stocking in the distribution channels.

23 Jul 2010

Expert to speak on challenges, issues in development, implementation of REMS

At two Food and Drug Administration meetings, Sidney H. Schnoll, MD, PhD, Vice President, Pharmaceutical Risk Management Services of PinneyAssociates, will discuss the need for predictability, feasibility and transparency to ensure that Risk Evaluation and Mitigation Strategies benefit patient safety and public health.

23 Jul 2010

News outlets report on medical intellectual property developments, drug access issues

Inter Press Service reports on a recent symposium on access to medicine, "jointly hosted by the WHO, the World Trade Organization and the World Intellectual Property Organisation."

23 Jul 2010

Forest, Merz settle NAMENDA patent infringement litigation

Forest Laboratories, Inc. Forest Laboratories Holdings, Ltd., Merz Pharma GmbH & Co. KGaA, and Merz Pharmaceuticals GmbH announced today that they have entered into settlement agreements with all remaining defendants in patent infringement litigation related to Forest's NAMENDA® (memantine hydrochloride) immediate release tablets.

23 Jul 2010

Sensient to expand pharmaceutical coating capabilities

Sensient Technologies Corporation plans to expand its pharmaceutical coating capabilities at its Color Group headquarters site in St. Louis, Missouri, in order to serve growing demand for its products.

23 Jul 2010

Dr Payne to receive RPS conference practice research award

Dr Katherine Payne has been announced the winner of the Pharmacy Practice Research Trust 2010 Royal Pharmaceutical Society (RPS)Conference Practice Research Award. The award will be presented at the conference on Monday, 6th September when Dr Payne will deliver a plenary lecture on her prize-winning research.

23 Jul 2010

Discontinuing epoetin can normalize hemoglobin levels in hemodialysis patients

Discontinuing the anemia drug epoetin may be more effective than reducing the dose for normalizing potentially dangerous high hemoglobin levels in hemodialysis patients, according to a study appearing in an upcoming issue of the Clinical Journal of the American Society Nephrology. The results provide useful information about the balance required between administering epoetin and achieving target hemoglobin levels.

23 Jul 2010

Human Genome Sciences second-quarter revenues increase to $38.8 million

Human Genome Sciences, Inc. today announced financial results for the quarter ended June 30, 2010, and provided highlights of recent key developments.

23 Jul 2010

New drug to treat chronic pain in SCD patients

A University of Minnesota Medical School research team led by Kalpna Gupta, Ph.D., has discovered that cannibinoids offer a novel approach to ease the chronic and acute pain caused by sickle cell disease.Using a mouse model of SCD, Gupta and University of Minnesota colleagues studied the pain mechanisms by observing animals that exhibited both musculoskeletal pain and temperature sensitivity, symptoms similarly experienced by humans with SCD. The team compared two classifications of drugs in their ability to manage pain sensed by the animals, the traditionally prescribed classification of drugs, opioids, with a new therapeutic approach, cannabinoids, a synthetic compound based on marijuana derivatives. Currently, the only approved treatment for management of severe pain in SCD is opioids.

23 Jul 2010

FDA approves Mylan's ANDA for generic Solodyn ER tablets for acne treatment

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited received final approval on July 20 from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Minocycline Hydrochloride Extended Release Tablets (Minocycline ER), 45 mg, 90 mg and 135 mg, the generic version of Solodyn® ER, a treatment for acne, sold by Medicis Pharmaceuticals Corporation (Medicis). Mylan Pharmaceuticals Inc. commenced immediate shipment of the product after approval.

23 Jul 2010

FDA approves Impax's ANDA for generic OPANA ER 30mg tablet

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 (ANDA) for the generic version of OPANA® ER (oxymorphone hydrochloride) Extended Release 30mg tablet. In June 2010, the Company was granted final approval for the 5mg, 10mg, 20mg, and 40mg tablets.

23 Jul 2010

New HIV drug on the block

Johnson and Johnson’s experimental HIV drug rilpivirine or TMC278, a non-nucleoside reverse transcriptase inhibitor (NNRTI), is being developed for use in combination therapy for treating the human immunodeficiency virus (HIV) that causes AIDS. Two clinical trials with the drug has shown that although its effectiveness was same as the existing anti-HIV drugs, its side effects were fewer. On the flip side nearly twice as many patients failed to respond to treatment with the new drug.

22 Jul 2010

Bristol-Myers Squibb second-quarter net sales increase 2% to $4.8 billion

Bristol-Myers Squibb Company today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.

22 Jul 2010

Mylan enters settlement agreement with Forest Laboratories, Merz Pharmaceuticals for Namenda

Mylan Inc. today announced that it has entered into settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals related to Namenda® Tablets, 5 mg and 10 mg, known generically as Memantine Hydrochloride (HCl) Tablets.

22 Jul 2010