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FDA grants Fast Track designation to Corthera's relaxin for treating acute heart failure

Corthera Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to relaxin, the company's investigational drug for the treatment of acute heart failure (AHF). The Fast Track program facilitates the development and expedites the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

3 Oct 2009

Also in Global Health news: U.S. food aid declines; agriculture in Zimbabwe; U.S.-backed ITN network; reducing maternal mortality; DNDI expands; healthcare in Congo

Although U.S. food aid funding has increased by 53 percent over the last two years, a Government Accountability Office report on Wednesday said that during the same time period, the "amount of food delivered to address emergencies abroad fell 5 percent," the Washington Independent reports.

3 Oct 2009

Aid efforts continue after earthquake in Indonesia

"Foreign emergency rescue teams are racing to reach earthquake devastated areas of Indonesia's Sumatra island, as the death toll continues to rise" after a 7.6 magnitude-quake struck earlier this week, VOA News reports.

2 Oct 2009

sNDA for Clonicel submitted to the FDA

Addrenex Pharmaceuticals and Sciele Pharma, Inc., a Shionogi company today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

2 Oct 2009

Clinical study results demonstrate the efficacy of AFRESA inhalation powder

AFRESA (insulin human [rDNA origin]) Inhalation Powder, a well-tolerated, ultra rapid acting insulin, showed no significant changes in pulmonary function and sustained glycemic control in adult patients with type 2 diabetes over four years of continuous treatment, according to data presented today at the 45th Annual Meeting of the European Association for the Study of Diabetes.

2 Oct 2009

Opinions: Bridging the divide to stop the spread of HIV; ending future world hunger

"With less than half the people who need treatment having access and with each day more people becoming infected with HIV than are started on treatment, we are mortgaging our future. But we are also exposing a fundamental social injustice - between the privileged and the forsaken - a divide we can bridge," Michael Sidibe, the executive director of UNAIDS, writes in a Daily Nation opinion piece.

1 Oct 2009

Change in Heparin manufacturing - expected to decrease the potency

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

1 Oct 2009

CSIRO launches wellbeing plan for kids

Written by researchers in CSIRO's Preventative Health National Research Flagship and based on extensive research, The CSIRO Wellbeing Plan for Kids reduces the guess work for parents by focusing on key lifestyle habits that will make a significant difference in achieving a healthy and active lifestyle for the whole family.

1 Oct 2009

Orexigen's Empatic Phase 2b results demonstrate weight loss

Orexigen Therapeutics, Inc. today announced that its 24-week, Phase 2b trial for Empatic(TM) (bupropion SR/zonisamide SR), the Company's second late stage investigational combination drug for the treatment of obesity, met its primary efficacy endpoint by demonstrating statistically significantly greater weight loss for both Empatic doses compared to monotherapies and placebo.

1 Oct 2009

Health Canada approves VIBATIV for treating complicated skin and skin structure infections

Astellas Pharma Canada, Inc. announced today that Health Canada has approved VIBATIV(TM) (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

1 Oct 2009

CVRx commences enrollment in study evaluating the Rheos System to treat heart failure

CVRx, Inc. reported the first enrollment of a patient in the HOPE4HF Trial, a study that is evaluating the Rheos System to treat heart failure. The Rheos System uses Baroreflex Activation Therapy® technology, an entirely new non-pharmaceutical approach designed to treat cardiovascular disease. The HOPE4HF Trial is being conducted under an approved investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA).

1 Oct 2009

Addrenex submits a sNDA to the FDA for Clonicel

Sciele Pharma, Inc., a Shionogi company, and Addrenex Pharmaceuticals today announced that Addrenex has submitted a supplemental New Drug Application (sNDA) to the United States Food and Drug Administration (FDA) for Clonicel (modified-release clonidine) to treat attention deficit hyperactivity disorder (ADHD).

1 Oct 2009

Diamedix files a 510(k) premarket submission with the FDA for its Mago4S assay system

IVAX Diagnostics, Inc. announced today that its U.S. subsidiary headquartered in Florida, Diamedix Corporation, has filed a 510(k) premarket submission with the U.S. Food and Drug Administration (“FDA”) for its next -generation fully automated Enzyme-linked Immunosorbent Assay (“ELISA”) system for autoimmune and infectious disease testing, named the Mago®4S.

1 Oct 2009

FDA-regulated product information for consumers and health care professionals

The U.S. Food and Drug Administration today issued its Strategic Plan for Risk Communication, which outlines the agency's efforts to disseminate more meaningful public health information.

1 Oct 2009

FDA releases first draft guidance on Risk Evaluation and Mitigation Strategies for select drugs

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

1 Oct 2009

FDA updates consumers on food and medical safety

The U.S. Food and Drug Administration has posted on its Web site several Consumer Update videos.

1 Oct 2009

Cutting Edge Information hopes to see ill patients have speedier access to potential cures

The FDA has approved the first set of vaccines aimed at preventing H1N1 infection after an approval process of less than four months. Cutting Edge Information is currently analyzing the lessons learned that may emerge for both the Food and Drug Administration (FDA) and life science firms after this crisis experience.

1 Oct 2009

CCF to continue its million dollar ad campaign against NYC's PSA campaign

Today, the Center for Consumer Freedom (CCF) is running a full-page ad in the New York Times, continuing its million dollar ad campaign against the New York City Department of Health's hyperbolic "Don't drink yourself fat" PSA campaign. The Center will also continue to run ads in the New York Daily News and New York Post that ask New Yorkers, "What's Next?" and "Big Apple or Big Brother?"

1 Oct 2009

USPTO allows BioMarin's claims covering the approved administration of sapropterin dihydrochloride with food

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) announced today that the United States Patent and Trademark Office has allowed claims covering the approved administration of Kuvan® (sapropterin dihydrochloride) with food, based on the discovery that food increases the bioavailability of Kuvan. The company expects that the patent, which expires in 2024, will officially issue later this year.

1 Oct 2009

Americans urged to carry an up-to-date medication list

A medication list can provide emergency medical personnel with lifesaving information and help prevent the nearly 1.5 million(1) people harmed by medication-related errors every year.

1 Oct 2009

Food News and Research

FDA grants Fast Track designation to Corthera's relaxin for treating acute heart failure

Also in Global Health news: U.S. food aid declines; agriculture in Zimbabwe; U.S.-backed ITN network; reducing maternal mortality; DNDI expands; healthcare in Congo

Aid efforts continue after earthquake in Indonesia

sNDA for Clonicel submitted to the FDA

Clinical study results demonstrate the efficacy of AFRESA inhalation powder

Opinions: Bridging the divide to stop the spread of HIV; ending future world hunger

Change in Heparin manufacturing - expected to decrease the potency

CSIRO launches wellbeing plan for kids

Orexigen's Empatic Phase 2b results demonstrate weight loss

Health Canada approves VIBATIV for treating complicated skin and skin structure infections

CVRx commences enrollment in study evaluating the Rheos System to treat heart failure

Addrenex submits a sNDA to the FDA for Clonicel

Diamedix files a 510(k) premarket submission with the FDA for its Mago4S assay system

FDA-regulated product information for consumers and health care professionals

FDA releases first draft guidance on Risk Evaluation and Mitigation Strategies for select drugs

FDA updates consumers on food and medical safety

Cutting Edge Information hopes to see ill patients have speedier access to potential cures

CCF to continue its million dollar ad campaign against NYC's PSA campaign

USPTO allows BioMarin's claims covering the approved administration of sapropterin dihydrochloride with food

Americans urged to carry an up-to-date medication list

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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