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Report on the type 2 diabetes drug market in Brazil

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, forecasts that the type 2 diabetes drug market in Brazil will grow from $417 million in 2008 to $834 million in 2013.

3 Dec 2009

Endo Pharmaceuticals receives FDA complete response letter for AVEED NDA

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone.

3 Dec 2009

FDA approves manufacture of Amneal Pharmaceuticals' Nizatidine Oral Solution

Amneal Pharmaceuticals is pleased to announce that it has received U.S. FDA approval to manufacture Nizatidine Oral Solution in the 15 mg/mL strength effective November 18, 2009. It is an AA-rated, therapeutically equivalent alternative to Axid® Oral Solution (a licensed trademark of Braintree Labs). Nizatidine Oral Solution is the first available generic in oral solution form and marks Amneal’s fourth liquid approval.

3 Dec 2009

Tripep receives approval to extend ChronVac-C study

Today Tripep (STO:TPEP) received the approval from the Swedish Medical Products Agency and the local ethical committee to give three patients in the highest dose group in the ChronVac-C® study one additional treatment with the therapeutic vaccine.

3 Dec 2009

FAU professor highlights the need for extensive randomized trials to distinguish drug benefits

In a commentary published in the December 2, 2009 issue of the Journal of the American Medical Association, Charles H. Hennekens, M.D., the first Sir Richard Doll Research Professor in the Charles E. Schmidt College of Biomedical Science at Florida Atlantic University, said, "To detect the most likely small to moderate benefits or harm of drugs requires randomized trials of sufficient size and duration. Overreliance on small trials, meta-analyses or subgroup analyses can lead to misleading conclusions."

3 Dec 2009

Nonanesthesiologist-administered propofol for GI procedures safe

The worldwide safety experience of endoscopist-administered propofol sedation now exceeds 600,000 patients. The low rate of serious adverse events underscores the safety of nonanesthesiologist-administered propofol (NAAP) for gastrointestinal (GI) procedures, provided that it is administered by a team of individuals who have received training specific to the administration of propofol according to the "Position statement: nonanesthesiologist administration of propofol for GI endoscopy" issued by the four major gastroenterology and hepatology societies.

3 Dec 2009

China's SFDA initiates quality investigation of Simcere Pharmaceutical Group subsidiary's rabies vaccine

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") has initiated a comprehensive investigation into quality issues regarding human use rabies vaccine (vero cell) manufactured by Simcere's subsidiary Jiangsu Yanshen Biological Technology Stock Co., Ltd. ("Jiangsu Yanshen").

3 Dec 2009

NOXXON Pharma achieves important milestone in drug discovery

NOXXON Pharma AG (NOXXON), the biopharmaceutical company focusing on the development of novel medicines based on its unique proprietary Spiegelmer® technology, announced today the achievement of an important milestone in its drug discovery and development partnership with Eli Lilly and Company.

3 Dec 2009

Positive results from NanoBio's recombinant H5N1 flu antigen-nanoemulsion vaccine combination study

NanoBio Corporation today announced positive results from studies in mice in which immune responses were evaluated following administration of 5µg doses of recombinant H5N1 pandemic flu antigen combined with the company’s novel nanoemulsion vaccine. These studies are unique because the adjuvant was administered for the first time by subcutaneous (SC) and intramuscular (IM) injections.

3 Dec 2009

Macular Health eye vitamin supplement improves visual acuity

Adults are more likely to lose their vision than be diagnosed with cancer. For adults 65 and over, the odds of losing vision are one in three, whereas the odds of a man developing prostate cancer are one in six and odds of a woman developing breast cancer are one in nine. Vision loss threatens the overall health of aging adults by increasing the risk of injuries, depression and inability to complete daily tasks.

3 Dec 2009

Lunasin may have important health benefits, two new studies report

Two new University of Illinois studies report that lunasin, a soy peptide often discarded in the waste streams of soy-processing plants, may have important health benefits that include fighting leukemia and blocking the inflammation that accompanies such chronic health conditions as diabetes, heart disease, and stroke.

3 Dec 2009

AstraZeneca and Targacept enter into agreement to develop and commercialize TC-5214

AstraZeneca and Targacept, Inc. today announced a collaboration and license agreement for the global development and commercialization of TC-5214, Targacept’s late-stage investigational product for major depressive disorder (MDD).

3 Dec 2009

Roche ships additional quantities of Tamiflu oral suspension

Roche announced today that it has begun shipping additional quantities of Tamiflu® (oseltamivir phosphate) oral suspension (liquid).

3 Dec 2009

Researchers to publish a paper on the availability of 'Spice' drugs online

A paper to be published this month by University of Hertfordshire researchers about the availability of 'Spice' drugs online will raise new concerns about its mood altering effects.

3 Dec 2009

Cephalon's lawsuit against Teva Pharmaceuticals for patent infringement of NUVIGIL tablets

Cephalon, Inc. today announced that it has filed a lawsuit in U.S. District Court in Delaware against Teva Pharmaceuticals USA, Inc. for infringement of U.S. Patent Nos. 7,132,570 (the "'570 Patent"), 7,297,346 (the "'346 Patent") and RE37,516 (the "'516 Patent") for the Cephalon product NUVIGIL® (armodafinil) Tablets [C-IV].

3 Dec 2009

FDA grants Fast Track designation for Keryx Biopharmaceuticals' KRX-0401

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 the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.

3 Dec 2009

Beta 2 adrenergic agonist drugs linked to autism-spectrum disorders

Commonly prescribed beta 2 adrenergic agonist drugs for the treatment of asthma in pregnant women as well as pre-term labor may increase the incidence of autism-spectrum disorders, psychiatric pathology, cognitive problems and poor school performance in their children, according to a new study published in the December 2009 issue of the American Journal of Obstetrics & Gynecology.

3 Dec 2009

The Hill examines push to get more U.S. funding for malaria medicines

The Hill examines Medicines for Malaria Venture's (MMV) efforts to get more U.S. funding for its work. According to the newspaper, the group is "asking USAID and Congress to redirect more money beginning next year to drug research and development from a pot of funds used to cover the range of efforts to treat and prevent malaria, such as providing mosquito nets."

3 Dec 2009

U.S. H1N1 cases decreasing, CDC says; HHS to review approach to health-threat preparedness

The number of H1N1 (swine flu) cases in the U.S. appears to be decreasing, the CDC said Tuesday, CQ HealthBeat reports. "Flu was widespread in 32 states by the end of the week of Nov. 21, a decrease from 43 states in the prior week and 46 states earlier this fall, according to the CDC," the news service writes. "

3 Dec 2009

Impax Laboratories acquires ANDA from Watson Pharmaceuticals and Cobalt Laboratories

Impax Laboratories, Inc. today announced it acquired Abbreviated New Drug Applications (ANDA) from Watson Pharmaceuticals and Cobalt Laboratories, a subsidiary of Arrow Group.

2 Dec 2009