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GSK confirms FDA advisory committees' vote to allow Avandia to remain on the market

GlaxoSmithKline confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions to withdrawal from the U.S. market.

15 Jul 2010

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

Nabi Biopharmaceuticals announced today that it has completed enrollment in the first Phase III clinical trial of NicVAX® (Nicotine Conjugate Vaccine), the company's innovative and proprietary investigational vaccine being developed to treat nicotine addiction and prevent smoking relapse.

15 Jul 2010

U.S. taxpayers spend equal amounts on non-emergency food aid and shipping, study says

IRIN examines the findings of a study about the costs and effects of the U.S. Agricultural Cargo Preference policy, noting that "U.S. taxpayers spend about $140 million every year on non-emergency food aid in Africa, and roughly the same amount to ship food aid to global destinations on U.S. vessels; money that could have been used to feed more people."

15 Jul 2010

Mylan subsidiary receives FDA final approval for Nabumetone Tablets ANDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Nabumetone Tablets USP, 500 mg and 750 mg.

15 Jul 2010

KRX-0401 receives Orphan Drug designation from FDA for treatment of neuroblastoma

Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 (perifosine) has received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants for which there are no FDA approved therapies.

15 Jul 2010

Mylan to acquire Bioniche Pharma for $550M

Mylan Inc. today announced plans to acquire Bioniche Pharma Holdings Limited, a privately held, global injectable pharmaceutical company for $550 million in cash. Bioniche Pharma will provide Mylan not only an immediate entry into the North American injectables market but also a platform for future growth opportunities. This transaction is expected to be accretive to Mylan's earnings in year one, without accounting for any operational or other synergies.

15 Jul 2010

Babies fed cow's milk in first 15 days of life are protected from dangerous allergies later on

Many doctors suggest that whole cow's milk be avoided in the early months of an infant's feeding. Lactation specialists go even further, counseling "mother's milk only" until baby starts eating solid food. But new research from Tel Aviv University says that mothers who feed their babies cow's milk in the first 15 days of life may be protecting their children from dangerous allergies later on.

15 Jul 2010

Aeterna Zentaris' partner Keryx receives FDA orphan-drug designation for perifosine in neuroblastoma

Aeterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, Inc., has been granted orphan-drug designation by the U.S. Food and Drug Administration for perifosine, Aeterna Zentaris' novel, potentially first-in-class, oral Akt inhibitor, for the treatment of neuroblastoma.

15 Jul 2010

Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) today announced it had received clearance from the US Food and Drug Administration (FDA) to commence a phase 2 study to investigate VivaGel® for the treatment of bacterial vaginosis (BV).

15 Jul 2010

OraVerse MAA accepted for review in five key European countries

Sanofi-Aventis Deutschland GmbH and Novalar Pharmaceuticals, Inc. today announced that the Marketing Authorization Application (MAA) for OraVerse has been accepted for review by the regulatory agencies of the United Kingdom (UK), Germany, Italy, France and Spain. OraVerse is the first and only local anesthesia reversal agent that accelerates the return of normal sensation and function following routine dental procedures. OraVerse is approved for use in the U.S. by the Food and Drug Administration and sold by Novalar direct to U.S. dentists.

14 Jul 2010

Microtest white paper guides medical device manufacturers in applying new FDA regulations to combination products

A new free, white paper that guides medical device manufacturers in the complicated process of applying new U.S. Food and Drug Administration (FDA) regulations to combination products embedded with pharmaceutical or biologic components is now available from Microtest Laboratories (http://www.microtestlabs.com/combination-products-20/)

14 Jul 2010

Comprehensive evaluation report of EU Platform for Action on Diet, Physical Activity & Health released

Five years ago, the European Commission created the EU Platform for Action on Diet, Physical Activity & Health, which brought together a variety of concerned stakeholders and challenged them to respond to the rising tide of obesity in Europe.

14 Jul 2010

Scientists discover three human antibodies that neutralize HIV

Scientists have discovered three previously unknown human antibodies that neutralize HIV, two of which target a broad range of HIV strains. The findings, reported online July 8 in two Science papers, add a level of encouragement to the AIDS vaccine research field.

14 Jul 2010

Tips for first-time moms to enjoy feeding moments with their baby

For a majority of first-time moms feeding their baby can be an emotional and stressful experience. New moms encountering these common, yet unexpected feeding challenges are not alone. A recent national survey, commissioned by Playtex®, revealed that 85 percent of first-time moms have experienced at least one feeding-related problem when caring for their new baby.

14 Jul 2010

Menthol does not increase smoking-related disease risk, says tobacco company

Lorillard Tobacco Company today released a submission to the Tobacco Products Scientific Advisory Committee (TPSAC) of the Food and Drug Administration, urging TPSAC to use objectivity and a single scientific standard in considering all worthy studies on the health effects of menthol in cigarettes rather than cherry picking studies and misrepresenting findings.

14 Jul 2010

Pierre Foods unveils new line of more nutritious school menu options for students

Pierre Foods, Inc. today officially unveiled Smart Picks—its new line of more nutritious school menu options—at the School Nutrition Association's Annual National Conference, giving students across the nation a reason to look forward to cafeteria lunches this coming fall. While other food manufacturers have committed to offering students more nutritious meal options in the coming two to five years, Smart Picks will be ready to serve in cafeterias when school begins next month.

14 Jul 2010

Evidence-based guidelines could help prevent dangerous radiation overdoses, says MedSolutions

Utilization management programs that use evidence-based guidelines to ensure appropriate use of diagnostic imaging tests could help prevent dangerous radiation overdoses like the one highlighted in a recent New England Journal of Medicine editorial, said MedSolutions, a leading provider of medical management services.

14 Jul 2010

Obama administration marks 6-month Haitian earthquake anniversary

Marking the six month anniversary of Haiti's major earthquake, President Barack Obama thanked Dominican Republic President Leonel Fernandez on Monday for his country's help, Agence France-Presse reports.

14 Jul 2010

FDA opens two-day hearing to examine safety of diabetes drug Avandia

The Fiscal Times: "There will be more at stake than just one drug's future when the Food and Drug Administration opens a two-day hearing Tuesday on the safety of the diabetes drug Avandia. The 30-member panel of outside experts will also be rendering judgment on research methods that are frequently used to compare effectiveness and are slated to become a pillar of the nation's drug safety monitoring system.

14 Jul 2010

Emergent awarded $107M HHS BARDA contract to develop large-scale manufacturing of BioThrax

Emergent BioSolutions Inc. announced today that it has signed a contract valued at up to $107 million with the Office of the Biomedical Advanced Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS), to develop and obtain regulatory approval for large-scale manufacturing of BioThrax® (Anthrax Vaccine Adsorbed) in Building 55. Building 55 is the company's large-scale state-of-the-art vaccine manufacturing facility in Lansing, Michigan.

14 Jul 2010

Food News and Research

GSK confirms FDA advisory committees' vote to allow Avandia to remain on the market

Enrollment complete in Nabi's first NicVAX Phase III clinical trial for nicotine addiction

U.S. taxpayers spend equal amounts on non-emergency food aid and shipping, study says

Mylan subsidiary receives FDA final approval for Nabumetone Tablets ANDA

KRX-0401 receives Orphan Drug designation from FDA for treatment of neuroblastoma

Mylan to acquire Bioniche Pharma for $550M

Babies fed cow's milk in first 15 days of life are protected from dangerous allergies later on

Aeterna Zentaris' partner Keryx receives FDA orphan-drug designation for perifosine in neuroblastoma

Starpharma gets FDA nod to start phase 2 bacterial vaginosis study for VivaGel

OraVerse MAA accepted for review in five key European countries

Microtest white paper guides medical device manufacturers in applying new FDA regulations to combination products

Comprehensive evaluation report of EU Platform for Action on Diet, Physical Activity & Health released

Scientists discover three human antibodies that neutralize HIV

Tips for first-time moms to enjoy feeding moments with their baby

Menthol does not increase smoking-related disease risk, says tobacco company

Pierre Foods unveils new line of more nutritious school menu options for students

Evidence-based guidelines could help prevent dangerous radiation overdoses, says MedSolutions

Obama administration marks 6-month Haitian earthquake anniversary

FDA opens two-day hearing to examine safety of diabetes drug Avandia

Emergent awarded $107M HHS BARDA contract to develop large-scale manufacturing of BioThrax

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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