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U.S. Marshals seizes unapproved drug products

At the request of the U.S. Food and Drug Administration, U.S. Marshals on March 31 seized a range of consumer products, including creams, capsules, tablets, gum, throat spray, and shampoos from a Haywood, Wis., manufacturer.

6 Apr 2010

Humana adopts radiology benefit management programs to reduce unnecessary radiation exposure

Humana Inc. has reduced unnecessary radiation exposure for its members by the equivalent of more than five million chest x-rays since 2004, demonstrating how health benefits companies can lead the way in improving the quality and safety of health.

6 Apr 2010

Qutenza 8% patch now available for pain associated with PHN: NeurogesX

NeurogesX, Inc. announced today that Qutenza® (capsaicin) 8% patch, the first and only product containing prescription-strength capsaicin, is now available. Clinical studies have shown that a single one-hour Qutenza application can provide three months relief from pain associated with postherpetic neuralgia, the nerve pain that can occur after shingles.

6 Apr 2010

Alpha cells in pancreas can convert into insulin-producing beta cells: Study

Alpha cells in the pancreas, which do not produce insulin, can convert into insulin-producing beta cells, advancing the prospect of regenerating beta cells as a cure for type 1 diabetes. The findings come from a study at the University of Geneva, co-funded by the Juvenile Diabetes Research Foundation, that is published today in the online edition of the scientific journal Nature.

6 Apr 2010

Preventive care, illegal immigrants and other health law notes

Reports continue to explore elements of the health reform debate such as the politically contentious issue of illegal immigrants' coverage, health care coverage for young adults, disease prevention and the next tanning-salon tax.

6 Apr 2010

Unilife's Unitract 1mL Insulin Syringes receive 510(k) market clearance

Unilife Corporation today announced it has received from the U.S. Food and Drug Administration 510(k) market clearance for the Unitract™ 1mL Insulin Syringes assembled at its Lewisberry, PA manufacturing facility.

6 Apr 2010

Dalfampridine drug for multiple sclerosis now available in the U.S.

A drug whose clinical benefit in treating multiple sclerosis was discovered at Rush University Medical Center was approved by the Food and Drug Administration on January 22 and is now available in the U.S.

6 Apr 2010

New formulation of controlled-release drug OxyContin approved

The U.S. Food and Drug Administration today approved a new formulation of the controlled-release drug OxyContin that has been designed to help discourage misuse and abuse of the medication.

6 Apr 2010

Chinese SFDA approves Erye Pharmaceutical to manufacture generic Cloxapen

NeoStem, Inc., an international biopharmaceutical company with operations in the U.S. and China, announced that its Suzhou Erye Pharmaceutical subsidiary ("Erye") recently received approval from the State Food and Drug Administration (SFDA) in China to manufacture the sterile active pharmaceutical ingredient (API) of the anti-infective cloxacillin sodium.

5 Apr 2010

Perrigo, Cobrek Pharmaceuticals receive FDA approval for generic Evoclin Foam 1%

Perrigo Company today announced that together with its partner Cobrek Pharmaceuticals, Inc. final approval has been received from the U.S. Food and Drug Administration to manufacture and market Clindamycin Phosphate Foam 1%, a generic version of Evoclin® Foam 1% of Stiefel. As the ANDA was first to file with a Paragraph IV certification against Evoclin®, 180 days of generic exclusivity was granted by the U.S. Food and Drug Administration.

5 Apr 2010

Canon receives FDA 510(k) clearance for CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera

Canon U.S.A., Inc., a leader in medical imaging, today announced the Canon CX-1 Hybrid Mydriatic/Non-Mydriatic Digital Retinal Camera has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

5 Apr 2010

Yongkangmen Health and Drug Chain Store to market and sell China Kangtai Cactus Biotech's products

China Kangtai Cactus Biotech Inc., a vertically integrated grower, developer, manufacturer and marketer of a variety of cactus-based products in China, announced today that it has signed a three-year marketing and sales agreement with Yongkangmen Health and Drug Chain Store Group Ltd. to sell its nutritious and patented cactus-based products, including nutraceuticals, health food, and health and energy drinks.

5 Apr 2010

Keryx Biopharmaceuticals' perifosine receives FDA Fast Track Designation

Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of refractory advanced colorectal cancer.

5 Apr 2010

Rexahn Pharmaceuticals submits Phase II protocol for study of Serdaxin in treatment of PD

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase II protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin® for the treatment of Parkinson's disease (PD).

5 Apr 2010

FDA grants Keryx Biopharmaceuticals Fast Track designation for perifosine

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, was granted Fast Track designation by the U.S. Food and Drug Administration for perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of refractory advanced colorectal cancer.

5 Apr 2010

Tiens Biotech Group's revenues for 2009 decline

Tiens Biotech Group (USA), Inc., http://www.tiens-bio.com , today announced financial results for the year ended December 31, 2009.

5 Apr 2010

China's SFDA finds certain batches of Jiangsu Yanshen's human use rabies vaccine substandard

Simcere Pharmaceutical Group, a leading pharmaceutical company specializing in the development, manufacturing, and marketing of branded generic and proprietary pharmaceuticals in China, today reported that China's State Food and Drug Administration ("SFDA") issued a statement on its investigation into the human use rabies vaccine manufactured by Jiangsu Yanshen Biological Technology Stock Co., Ltd.. Simcere obtained a controlling stake in Jiangsu Yanshen on October 24, 2009.

5 Apr 2010

Demand for kosher products grows on compliance with strict Jewish standards

Here's a paradox for Passover and year-round: With observant Jews numbering barely one million in a United States population of 310 million, why are 40-50 percent of food items on supermarket shelves kosher? Those and other insights into the amazing and constantly growing popularity of kosher foods appear in an article in Chemical & Engineering News, ACS' weekly newsmagazine.

5 Apr 2010

Attack on ‘junk food’ marketing to cut down on obesity

Amidst warnings of the obesity epidemic health authorities voicing their concern called for restrictions on fast non healthy food and alcohol advertising. Australia is one of the most overweight nations in the world, with more than 60% of adults and 25% children overweight or obese.

5 Apr 2010

New report assesses optimal future for REMS

Two years after the Food and Drug Administration Amendments Act of 2007 gave FDA new powers to require Risk Evaluation and Mitigation Strategies for higher risk drugs and biologics, a new report concludes that an optimal future for REMS is possible if the agency adopts a systems approach when designing REMS programs and takes advantage of new technologies -- from electronic medical records to genetic testing -- that are changing the way medicine is practiced.

5 Apr 2010