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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

CRF Health collects prestigious IPA Best of Health Awards

CRF Health garnered nine awards recently in the Business-to-Business categories of the Institute of Practitioners in Advertising Best of Health Awards, for their bold, new communications aimed at healthcare professionals involved in clinical trials. The awards were collected by their creative agency behind the campaign, Langland, at the awards night in London.

23 Jul 2010

Renhuang awarded AAA(1) rating

Renhuang Pharmaceuticals, Inc., a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and traditional Chinese medicines, today announced that the Company was recently awarded an AAA(1) rating by Chinese Academy of International Trade & Economic Cooperation of Ministry of Commerce.

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

Advanced Life Sciences enters debt for equity exchange agreement with CEO

Advanced Life Sciences Holdings, Inc., a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced that the Company has entered into a debt for equity exchange agreement with its chairman and CEO Michael T. Flavin, Ph.D.

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

Achieving meaningful use of inpatient EHR is top priority of hospital executives: Survey

According to a survey of U.S. hospital executives released today by CSC, steps to meet meaningful use requirements were already a priority for hospitals before the final rules to establish an incentive program for electronic health records were announced by the United States Department of Health and Human Services (HHS) on July 12.

23 Jul 2010

Maven Semantic announces updates to Bioinformatics medical professionals database

Maven Semantic announces updates to their Bioinformatics database.

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

European countries squeeze drug prices to stop health care spending growth

Reuters: More European countries are trying to limit what they pay for drugs in an attempt to control "runaway" health spending. "Concerns about the European pharmaceuticals market are increasing just as anxieties over U.S. healthcare reforms have abated, casting a shadow over Big Pharma's results season."

23 Jul 2010

NVHR releases statement on New York Times article 'Hope against Hepatitis C'

In response to today's New York Times article, "Hope against Hepatitis C," Andrew Muir, M.D., M.H.S., Director, Gastroenterology/Hepatology Research, Duke Clinical Research Institute and Steering Committee Member of the National Viral Hepatitis Roundtable (NVHR) released the following statement:

23 Jul 2010

Boehringer Ingelheim's VERxVE study of nevirapine meets primary endpoint

New data were presented today at the 18th International AIDS Conference from the VERxVE study that show an investigational, once-daily extended-release (400 mg QD) formulation of nevirapine was non-inferior to twice-daily immediate release Viramune® (nevirapine) tablets (200 mg BID), both in combination with Truvada® (tenofovir and emtricitabine) tablets in treatment-naive HIV-1 infected patients through 48 weeks.

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

NPS completes patient randomization in GATTEX Phase 3 study for PN dependent short bowel syndrome

NPS Pharmaceuticals, a specialty pharmaceutical company developing innovative therapeutics for rare gastrointestinal and endocrine disorders, today announced the completion of patient randomization in its Phase 3 registration study of GATTEX® (teduglutide). The double-blind, placebo-controlled safety and efficacy study, which is known as STEPS, is being conducted in patients with parenteral nutrition (PN) dependent short bowel syndrome (SBS) and is now fully randomized with 86 patients.

23 Jul 2010

Cytrx’s tamibarotene achieves molecular complete remission in advanced acute promyelocytic leukemia

CytRx Corporation, a biopharmaceutical company specializing in oncology, today announced that a 44-year-old female patient with advanced acute promyelocytic leukemia (APL) achieved molecular complete remission with no evidence of disease in the blood cells and/or bone marrow following treatment with CytRx's oncology drug candidate tamibarotene.

23 Jul 2010

States, senior groups, pressure Congress to continue extra Medicaid funding

CQ HealthBeat: "Despite doubts that Congress will pass legislation before the August recess to maintain higher levels of Medicaid funding, senior groups say they'll keep putting pressure on lawmakers to act this month. … In recent days AARP circulated a letter to each member of Congress calling on them to immediately pass legislation that would extend the higher levels of Medicaid funding afforded to states as part of the economic stimulus law.

23 Jul 2010

Unapproved cyanide antidote kits seized from Keystone Pharmaceuticals

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized $39,000 worth of products labeled as cyanide antidote kits from Keystone Pharmaceuticals in Laguna Hills, California. The seizure warrant was issued by the U.S. District Court for the Central District of California.

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