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VIVUS holds End-of-Review meeting with FDA for QNEXA NDA

VIVUS, Inc. today announced that it held an End-of-Review meeting with the Food and Drug Administration (FDA) for the New Drug Application (NDA) for QNEXA®, an investigational drug for the treatment of obesity. The meeting occurred on January 19th at the FDA's offices in Maryland and was attended by senior members of the FDA and VIVUS' management and consultants.

21 Jan 2011

EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Biogen Idec announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion recommending against approval of FAMPYRA to improve walking ability in adult patients with multiple sclerosis (MS) in the European Union. Biogen Idec intends to appeal this opinion and request a re-examination of the decision by the CHMP.

21 Jan 2011

Opinions: GAVI; Haitian women; Clinton's foreign policy

"Vaccines are among the greatest scientific contributions to human welfare. They are also some of the largest humanitarian contributions of developed nations to the rest of the world. So it is unfortunate that a decade of vaccine controversy has overshadowed a decade of vaccine miracles," Washington Post columnist Michael Gerson writes in an opinion piece reflecting on the contributions of the GAVI Alliance over the past decade.

21 Jan 2011

Health law: Filling in some policy details

News outlets flesh out specific provisions of the health law, including how some aspects of the measure impact small businesses, state implementation efforts and the individual mandate.

21 Jan 2011

Porter Adventist Hospital offers tips for healthier eating habits

It's now been a few weeks since we have made our New Year's resolutions to eat better and finally lose those last five pounds or more. It's time to check in and see if you've set yourself up for success this year. Brittany Glassett, registered dietitian at Porter Adventist Hospital has a few tips to keep in mind when setting - and keeping - new goals.

21 Jan 2011

Archimedes, FDA collaborate to develop computer model of clinical trials evaluating weight loss medications

Archimedes Inc., a healthcare modeling company, announced today that it has entered into a Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) to develop a computer model of clinical trials evaluating weight loss medications. The model will be used to obtain a better understanding of the benefits of weight loss against the long-term risks of cardiovascular outcomes in patients treated with weight loss drugs.

20 Jan 2011

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Vertex Pharmaceuticals Incorporated announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C.

20 Jan 2011

Genetic expression can be modified with natural substances to prevent chronic illness

Research findings demonstrating how genetic expression can be modified with natural substances to prevent chronic illness was the topic of an address by Jeffrey Bland, Ph.D., FACN, FACB, at the 8th Annual Scripps Center for Integrative Medicine 2011 conference in San Diego, California, January 13 - 16.

20 Jan 2011

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration (FDA) under the President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application (NDA) for Lamivudine and Zidovudine Tablets, 30 mg/60 mg.

20 Jan 2011

Perrigo to acquire Paddock Labs for $540M in cash

Perrigo Company today announced that it has signed a definitive agreement to acquire substantially all of the assets of Paddock Laboratories, Inc., a privately-held, Minneapolis-based manufacturer and marketer of generic pharmaceutical products for approximately $540 million in cash. Perrigo expects to receive a significant tax benefit as a result of the acquisition of Paddock's assets. The net present value of this tax benefit is estimated to be $95 million.

20 Jan 2011

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication. RiVax™ is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals.

20 Jan 2011

FDA approves Spectranetics PMA for manufacturing site change for CVX-300 laser system

Spectranetics Corporation today announced that the Food and Drug Administration (FDA) has approved the Company's premarket approval application (PMA) supplement requesting a manufacturing site change for the CVX-300® laser system.

20 Jan 2011

American Lung Association releases 2010 State of Tobacco Control Report

The American Lung Association released its State of Tobacco Control 2010 report today, which tracks progress on key tobacco control policies at the federal and state level, assigning grades based on whether laws are adequately protecting citizens from the enormous burden caused by tobacco use.

20 Jan 2011

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

ZIOPHARM Oncology, Inc., announced today that The Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) adopted a positive opinion for darinaparsin (Zinapar™ or ZIO-101) designation as an orphan medicinal product for the treatment of peripheral T-cell lymphoma (PTCL).

20 Jan 2011

CHI responds to FDA recommendations for 510(k) regulatory review process

California Healthcare Institute today released a statement in response to new U.S. Food and Drug Administration (FDA) recommendations that could transform the 510(k) regulatory review process for new medical devices, greatly affecting innovation and public health in California.

20 Jan 2011

American Academy of Dermatology's position statement on vitamin D reflects IOM's findings

The American Academy of Dermatology (Academy) has updated its position statement on vitamin D based on the results of a review of the increasing body of scientific literature on this vitamin and its importance for optimal health recently conducted by the National Academy of Sciences Institute of Medicine (IOM).

20 Jan 2011

FOLOTYN Phase 2 peripheral T-cell lymphoma study results published in Journal of Clinical Oncology

Allos Therapeutics, Inc. today announced that the Journal of Clinical Oncology has published data from the Company's pivotal Phase 2 PROPEL study demonstrating clinical activity of FOLOTYN® (pralatrexate injection) in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).

20 Jan 2011

Waters signs land-purchase agreement with Royal Bank of Scotland for new MS Headquarters in UK

Waters Corporation today announced it signed a land-purchase agreement with The Royal Bank of Scotland for a new Mass Spectrometry Headquarters in Wilmslow, Cheshire, near Manchester, U.K.

20 Jan 2011

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

Pervasis Therapeutics, Inc. today announced that the company is pursuing a matrix-embedded endothelial cell-based therapy (PVS-30200) to target and regulate cell stroma (the tumor environment or "ecosystem" that is comprised of various supporting cell types distinct from cancer cells) in order to prevent key processes that play a role in advancing solid tumor growth and metastasis.

20 Jan 2011

UMB enters license agreement with Bali BioSciences for new strategy to combat sepsis, HIV/AIDS

The University of Maryland, Baltimore's (UMB) Office of Technology Transfer has completed a license agreement with Bali BioSciences LLC, an early-stage company pursuing an unusual, yet clever, strategy to combat disease.

20 Jan 2011

Food News and Research

VIVUS holds End-of-Review meeting with FDA for QNEXA NDA

EMA CHMP issues negative opinion against Biogen Idec's FAMPYRA for multiple sclerosis

Opinions: GAVI; Haitian women; Clinton's foreign policy

Health law: Filling in some policy details

Porter Adventist Hospital offers tips for healthier eating habits

Archimedes, FDA collaborate to develop computer model of clinical trials evaluating weight loss medications

FDA accepts Vertex's telaprevir NDA for six-month Priority Review

Genetic expression can be modified with natural substances to prevent chronic illness

FDA provides tentative approval under PEPFAR for Matrix's Lamivudine and Zidovudine NDA

Perrigo to acquire Paddock Labs for $540M in cash

FDA grants Soligenix Orphan Drug Designation to RiVax for prevention of ricin intoxication

FDA approves Spectranetics PMA for manufacturing site change for CVX-300 laser system

American Lung Association releases 2010 State of Tobacco Control Report

ZIOPHARM's darinaparsin receives EMA COMP orphan drug designation for treatment of peripheral T-cell lymphoma

CHI responds to FDA recommendations for 510(k) regulatory review process

American Academy of Dermatology's position statement on vitamin D reflects IOM's findings

FOLOTYN Phase 2 peripheral T-cell lymphoma study results published in Journal of Clinical Oncology

Waters signs land-purchase agreement with Royal Bank of Scotland for new MS Headquarters in UK

Pervasis pursues matrix-embedded endothelial cell-based therapy to target and regulate cell stroma

UMB enters license agreement with Bali BioSciences for new strategy to combat sepsis, HIV/AIDS

Understanding cultivated meat and its global potential eBook

A New Approach to Preventing Bladder Cancer Recurrence

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

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