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Caraco enters into a consent decree with the FDA regarding its drug manufacturing operations

Caraco Pharmaceutical Laboratories, Ltd. announced today that it has entered into a consent decree with the U.S. Food and Drug Administration (FDA) regarding the company's drug manufacturing operations. The decree provides a series of measures that, when satisfied, will permit Caraco to resume manufacturing and distributing those products that are manufactured in its Detroit area facilities.

30 Sep 2009

FDA approves Mylan Pharmaceuticals' Carbidopa and Levodopa tablets

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Carbidopa and Levodopa Tablets USP, 10mg/100mg, 25mg/100mg and 25mg/250 mg.

30 Sep 2009

Sun Pharma Global issues notice to Labopharm regarding its generic versions of Ryzolt

Labopharm Inc. today announced it has received notice from Sun Pharma Global FZE advising that Sun has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for approval to market 100, 200 and 300 mg generic versions of Ryzolt(TM) (tramadol hydrochloride extended-release 100, 200 and 300 mg tablets) in the United States.

30 Sep 2009

Orphan drug designation for pixantrone applied by Cell Therapeutics

Cell Therapeutics, Inc. ("CTI") announced today that it has applied to the European Medicines Agency (EMEA) for orphan drug designation for pixantrone. CTI initiated the process of obtaining marketing approval in Europe in July, 2009, for the treatment of relapsed or refractory aggressive NHL.

30 Sep 2009

IDRI and Academia Sinica sign Memorandum of Understanding

On behalf of The Lilly TB Drug Discovery Initiative, the Infectious Disease Research Institute (IDRI) today signed a Memorandum of Understanding (MOU) with Academia Sinica, a research institution based in Taiwan, to collaborate in target-based screening for the discovery of new tuberculosis (TB) drugs.

30 Sep 2009

Mellow Hope granted H1N1 license by SFDA

The issuer's China based operating subsidiary Mellow Hope through its exclusive business partner Zhejiang Tianyuan Bio-pharmaceutical Co., Ltd has been granted H1N1 license on September 24, 2009 by SFDA (China Authority) http://eng.sfda.gov.cn/eng. Mellow Hope is the exclusive agent of Zhejiang Tianyuan Bio-pharmaceutical Co., Ltd for International marketing and sales.

30 Sep 2009

FDA's Structured Product Labeling to be discussed

The Center for Business Intelligence (CBI) is pleased to announce the full agenda for their forum on FDA's Structured Product Labeling (SPL R4). The inaugural program will be chaired by Theresa Brunone, Assistant Director, GlaxoSmithKline. The conference will take place in Washington, DC, on December 8-9, 2009.

30 Sep 2009

Non-human primate study results of Restanza released

Advanced Life Sciences Holdings, Inc., today announced positive top-line results from a pivotal, non-human primate study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) demonstrating statistical significance at a 90% survival rate against an inhaled lethal dose of plague.

30 Sep 2009

Tβ4 therapy in EAE mice improves neurological functional recovery

REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers at the Henry Ford Health System in Detroit, Michigan, demonstrated for the first time that Tβ4 treatment of EAE (experimental autoimmune encephalomyelitis – an animal model for multiple sclerosis) significantly improves neurological functional recovery.

30 Sep 2009

Sanofi-aventis announces study results comparing efficacy of Lantus to detemir

Sanofi-aventis announced today results of a head-to-head study providing further evidence on the efficacy of once-daily, 24-hour basal insulin Lantus(R) (insulin glargine (rDNA) injection) compared to twice-daily insulin detemir. The study was presented during the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Vienna.

30 Sep 2009

SATAI invests $1.045 million in Azaya Therapeutics

SATAI (www.satai.us) and the South Texas Regional Center of Innovation and Commercialization (www.strcic.com) today announced an investment of $1.045 million in Azaya Therapeutics, Inc. through the Texas Emerging Technology Fund (ETF) for the commercialization of Azaya’s proprietary Protein Stabilized Nanoparticle (PSN) technology platform to produce targeted, safer and more effective formulations of chemotherapy pharmaceuticals for the treatment of cancer.

30 Sep 2009

New anticoagulant therapy has fewer side-effects than warfarin

In an article reviewed by F1000 Medicine Faculty Members Robert Ruff, Brian Olshansky and Luis Ruilope, the blood-thinner dabigatran is shown to protect against stroke, blood clotting and major bleeding as effectively as warfarin, but with fewer side effects.

30 Sep 2009

Burzynski Research Institute and BBSF sign Research Agreement

The Burzynski Research Institute, Inc. (BRI) today announced that it has signed a Research Agreement with the UAB Division of Preventive Medicine, Biostatistics and Bioinformatics Shared Facility (BBSF) that will provide biostatistical and data management support for BRI’s ongoing Phase II and Phase III protocol studies of Antineoplaston (ANP) treatment for gliomas.

30 Sep 2009

Also in global health news: Drought in East Africa; improving food processing in Africa; Hajj pilgrims must take polio vaccine; fighting insecticide-resistant mosquitoes

"A severe and persistent five-year drought" is pushing "[m]ore than 23 million people ... towards severe hunger and destitution across East Africa, international aid agency Oxfam has warned as it launches a £9.5 million [about $15 million] emergency appeal," the U.K. Press Association reports (9/29). According to Reuters/New York Times, "Malnutrition is now above emergency levels in some areas and hundreds of thousands of valuable cattle are dying" (Wallis, 9/29).

30 Sep 2009

Reuters examines how HIV vaccine trial results will guide future studies

Reuters reports on how the results of an experimental AIDS vaccine, which showed modest potential for preventing infection, are leading researchers back "to the drawing board" as they try to better understand how the AIDS vaccine works.

30 Sep 2009

Study reveals that most Americans will refuse FDA authorized emergency use H1N1 flu vaccine

A majority of Americans would not take an H1N1 flu vaccine or drug additive authorized for emergency use by the Food and Drug Administration, according to a University of Pittsburgh Graduate School of Public Health and University of Georgia study. The study, available online today in Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science, found that fewer than 10 percent of those surveyed said they would be willing to take such a vaccine or drug and nearly 30 percent remained undecided.

30 Sep 2009

Total Wellness ready to meet increased demand for the seasonal flu vaccine

Omaha-based Total Wellness, a leading provider of corporate health and wellness services, encourages employers – both large and small – to follow recommendations made by the Center for Disease Control and Prevention (CDC), which encourages employees to receive flu shots this fall.

30 Sep 2009

Aetna announces first-dollar coverage for H1N1 flu vaccine administration

Aetna announced today that it will provide first-dollar coverage for the administration of the H1N1 flu vaccine for all of its fully-insured health plan members, and for all members of self-funded plans unless directed otherwise by the plan sponsor. Aetna is offering this coverage even in instances where members’ plans do not include coverage for preventive care or have limits on such coverage.

30 Sep 2009

Renewed GMP certification for China Biologic Products' Qianfeng subsidiary

China Biologic Products, Inc. (OTC Bulletin Board: CBPO) ("China Biologic," or the "Company"), one of the leading plasma-based pharmaceutical companies in the People's Republic of China ("PRC"), today announced that on September 2, 2009, the PRC's State Food and Drug Administration (the "SFDA") renewed SFDA certification of compliance with Good Manufacturing Practices ("GMP") for the production facility of Qianfeng Biological Products Co., Ltd. ("Qianfeng"), China Biologic's indirectly owned subsidiary.

29 Sep 2009

90-day supply program to improve overall healthcare

Walgreens (NYSE:WAG) today launched a broad initiative for 90-day prescriptions that promotes delivery of maintenance and chronic care medication through its national network of more than 7,000 community pharmacies and employer worksite centers.

29 Sep 2009