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Hospira to acquire Orchid's pharmaceuticals business for $400 million

Hospira, Inc., the world leader in generic injectable pharmaceuticals, and Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company and among the top-five generic beta-lactam antibiotics manufacturers globally, today announced an agreement for Hospira to acquire Orchid's generic injectable finished-dosage form pharmaceuticals business for approximately $400 million.

15 Dec 2009

FDA opens third city post in Latin America

As part of its continuing effort to buttress food and medical product safety in this country by working with its regulatory partners overseas, the U.S. Food and Drug Administration today announced the opening of its Mexico City post. This is the Agency's third post in Latin America and its tenth international post in the past 13 months.

15 Dec 2009

FDA grants marketing approval for EnzySurge's new SilverStream solution for prescription use

EnzySurge Ltd. (EnzySurge), a provider of innovative solutions for the advanced chronic wound management market, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its new SilverStream(TM) solution for prescription use. The FDA also cleared DermaSept, an Over-the-Counter version of the SilverStream product.

15 Dec 2009

Positive results from study comparing exenatide once weekly to BYETTA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes.

15 Dec 2009

Spinal Restoration receives FDA SPA concurrence letter for its Phase 3 Biostat System study

Spinal Restoration, Inc. announced today it has received a Special Protocol Assessment concurrence letter from the U.S. Food and Drug Administration (FDA) for the design of its Phase 3 study of the Biostat System for the treatment of chronic discogenic low back pain.

15 Dec 2009

Prescription drug import amendment divides Senate Democrats

The Senate is battling over a proposed amendment that would allow prescription drugs to be imported from other countries where prices are lower.

15 Dec 2009

University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

GenSpera, Inc. announced today that the Institutional Review Board (IRB) at the University of Wisconsin, in Madison, WI, has approved a Phase I study of its target activated pro-drug, G-202, for the treatment of cancer. The FDA (US Food and Drug Administration) approved the study in September. GenSpera expects to enroll the first study patient early in the first quarter of 2010.

15 Dec 2009

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Jazz Pharmaceuticals, Inc. announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia.

15 Dec 2009

Decline in reducing youth smoking and increase in smokeless tobacco use

The 2009 Monitoring the Future Survey released today by the National Institute of Drug Abuse shows that the nation continues to make gradual progress in reducing youth smoking, but declines have slowed significantly compared to the dramatic gains early in the decade. In especially troubling news, the survey also finds that smokeless tobacco use has increased among 10th and 12th graders in recent years, a period during which tobacco companies have introduced a slew of new smokeless tobacco products and significantly increased marketing for smokeless tobacco.

15 Dec 2009

Cancer patients with dementia have lower survival rate than patients with cancer alone, says study

A new study published by researchers from the University of Georgia and the Moffitt Cancer Center in Tampa, Fla., has found that cancer patients with dementia have a dramatically lower survival rate than patients with cancer alone, even after controlling for factors such as age, tumor type and tumor stage.

15 Dec 2009

Haemonetics alleges continued patent infringement by Fenwal, files a new lawsuit

Haemonetics Corporation announced today that it has filed a new legal action to stop Fenwal Inc.'s continued patent infringement resulting from Fenwal's just released red cell collection kits, using a modified separation chamber. Fenwal allegedly modified its separation chamber to circumvent Haemonetics' patent and the injunction entered by the Court prohibiting Fenwal's continued sale of infringing products after December 1, 2010.

15 Dec 2009

Seattle Genetics announces collaboration to globally develop and commercialize brentuximab vedotin

Seattle Genetics, Inc. and Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today jointly announced that Seattle Genetics and Millennium have entered into an agreement to globally develop and commercialize brentuximab vedotin (SGN-35).

15 Dec 2009

FDA publishes cGMPs for PET drugs

The U.S. Food and Drug Administration (FDA) announced publication of a final regulation on current good manufacturing practices (cGMPs) for the production of positron emission tomography (PET) drugs, as well as a guidance document describing acceptable approaches that would enable PET drug producers to meet the requirements in the proposed regulation.

15 Dec 2009

Study says children are still bombarded with TV ads for unhealthy food choices

A new study released Monday, Dec. 14, in Washington, D.C., criticizes the nation's food and beverage industry for failing to shift their marketing efforts aimed at children. The report said television advertising continues to contribute to epidemic levels of obesity, despite industry promises of reform.

15 Dec 2009

Study explores comorbidity of medical complaints and insomnia symptoms in school-aged children

A study in the Dec. 15 issue of the Journal of Clinical Sleep Medicine indicates that significant associations exist between parent-reported insomnia symptoms and medical complaints of gastrointestinal regurgitation and headaches in young school-aged children.

15 Dec 2009

More support for FDA ban on flavored cigarettes

New research showing that thrill-seeking teenagers are especially susceptible to fruit-flavored cigarettes is in line with the recent ban on the sale of flavored cigarettes by the U.S. Food and Drug Administration (FDA) in September 2009. According to the FDA, the ban, authorized by the new Family Smoking Prevention and Tobacco Control Act, is part of a national effort by the FDA to reduce smoking, which is the leading preventable cause of death in America.

15 Dec 2009

Health hazards of BPA: Call for FDA to make its announcement before Christmas

Environmental health advocates hope that U.S. FDA will make its promised announcement about health hazards of bisphenol A (BPA), a synthetic sex hormone linked to cancer, behavioral changes, reproductive harm and other illnesses, in time for Christmas.

15 Dec 2009

USPTO issues Notice of Allowance to Transcept Pharmaceuticals for Intermezzo claims

Transcept Pharmaceuticals, Inc. today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. patent application no. 11/060,641, which covers the composition and use of Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate.

15 Dec 2009

Poor access to safe and nutritious foods can pose serious health challenges for diabetes patients

Preparing a healthy meal loaded with fresh vegetables seems like an easy thing to do. But for some people living with diabetes, having access to nutritious food can be difficult --- and may have a detrimental effect on their health and well-being, according to a new study led by Ryerson University.

15 Dec 2009

Manchester Pharmaceuticals' Chenodal now available for patients suffering from gallstones

Manchester Pharmaceuticals, Inc.(TM) announced today the availability of Chenodal(TM) 250 mg (chenodiol tablets). On October 22, 2009, the US Food and Drug Administration (FDA) approved Chenodal, an important therapy for patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age.

15 Dec 2009

Food News and Research

Hospira to acquire Orchid's pharmaceuticals business for $400 million

FDA opens third city post in Latin America

FDA grants marketing approval for EnzySurge's new SilverStream solution for prescription use

Positive results from study comparing exenatide once weekly to BYETTA

Spinal Restoration receives FDA SPA concurrence letter for its Phase 3 Biostat System study

Prescription drug import amendment divides Senate Democrats

University of Wisconsin IRB approves GenSpera's G-202 Phase I study for cancer

Jazz Pharmaceuticals announces submission of JZP-6 NDA for treatment of fibromyalgia

Decline in reducing youth smoking and increase in smokeless tobacco use

Cancer patients with dementia have lower survival rate than patients with cancer alone, says study

Haemonetics alleges continued patent infringement by Fenwal, files a new lawsuit

Seattle Genetics announces collaboration to globally develop and commercialize brentuximab vedotin

FDA publishes cGMPs for PET drugs

Study says children are still bombarded with TV ads for unhealthy food choices

Study explores comorbidity of medical complaints and insomnia symptoms in school-aged children

More support for FDA ban on flavored cigarettes

Health hazards of BPA: Call for FDA to make its announcement before Christmas

USPTO issues Notice of Allowance to Transcept Pharmaceuticals for Intermezzo claims

Poor access to safe and nutritious foods can pose serious health challenges for diabetes patients

Manchester Pharmaceuticals' Chenodal now available for patients suffering from gallstones

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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