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94-year-old crusader seeks ban on trans fats in the American diet

Fred Kummerow, a 94-year-old University of Illinois veterinary biosciences professor emeritus who still conducts research on the health effects of trans fats in the diet, filed the petition with the FDA last month. The petition is now posted on the FDA Web site, and public comments are invited. (See below for information on viewing the petition and making a comment.)

4 Sep 2009

FDA review on postmarketing studies for approved drugs and biologics

Makers of approved drugs and biologics generally are meeting their regulatory obligations and complete their postmarketing studies in a timely manner, according to a study released today by the U.S. Food and Drug Administration.

4 Sep 2009

Eating at irregular times influences weight gain

Eat less, exercise more. Now there is new evidence to support adding another "must" to the weight-loss mantra: eat at the right time of day.

4 Sep 2009

StemCells’ novel neuroprotective approach for treating neurodegenerative diseases

StemCells, Inc. today announced the publication of preclinical data demonstrating for the first time that transplantation of its proprietary, purified human neural stem cells delays the loss of motor function in a mouse model of infantile neuronal ceroid lipofuscinosis (NCL).

4 Sep 2009

Americans' health perceptions contradict national statistics

We think we’re healthier than we actually are, suggests a new survey from market research leader Mintel. Surveying Americans about their health, Mintel found people’s perceptions strongly contradict national statistics about obesity, illness and wellness.

4 Sep 2009

FDA approves new xTAG Cystic Fibrosis 39 Kit v2 from Luminex

Luminex Corporation (NASDAQ: LMNX), the worldwide leader in multiplexed solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a new cystic fibrosis (CF) test: the xTAG® Cystic Fibrosis 39 Kit v2.

From Thermo Fisher Scientific Inc. 4 Sep 2009

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV- (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

4 Sep 2009

PASS LP spinal system for treating complex deformities receives FDA approval

MEDICREA announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market the PASS LP Iliac Fixation within the United States. This new Iliac Fixation supplements the PASS LP range, a ultra Low Profile Polyaxial Spine System launched recently.

4 Sep 2009

SFDA approves production license for Sinovac's H1N1 vaccine

Sinovac Biotech Ltd. (NYSE: SVA), a leading provider of biopharmaceutical products in China, announced today that the State Food and Drug Administration (SFDA) has approved the registration application for PANFLU.1, Sinovac's H1N1 vaccine, and has issued Sinovac a production license for this vaccine.

4 Sep 2009

Acurox's New Drug Application discussed with the FDA

Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc. announced today that they met with the U.S. Food and Drug Administration ("FDA") on September 2, 2009 to discuss the FDA’s June 30, 2009 Complete Response Letter regarding the New Drug Application for Acurox (oxycodone HCl and niacin) Tablets CII (NDA).

4 Sep 2009

IND for Cytopia's CYT387 clears the FDA review

Cytopia Limited's Investigational New Drug Application (IND) for CYT387 has passed US Food and Drug Administration (FDA) review. CYT387 is a small-molecule oral JAK1/JAK2 kinase inhibitor designed to treat various haematological disorders.

4 Sep 2009

Also in global health news: Africa measles eradication; water, food security in South Asia; MDR-TB in Mumbai; SADC summit; U.S. Cuba embargo

WHO Regional Director for Africa Luis Gomes Sambo said Tuesday during the 59th Session of the WHO Regional Committee for Africa in Kigali, Rwanda, that measles could be eradicated from the continent by 2020, citing an 89 percent reduction in the number of deaths caused by measles between 2000 and 2007, Angencia AngolaPress reports.

4 Sep 2009

Communal nesting may provide evolutionary advantage for reptiles

Reptiles are not known to be the most social of creatures. But when it comes to laying eggs, female reptiles can be remarkably communal, often laying their eggs in the nests of other females. New research in the September issue of The Quarterly Review of Biology suggests that this curiously out-of-character behavior is far more common in reptiles than was previously thought.

4 Sep 2009

Type 2 diabetic people not consuming healthy diets

People with type 2 diabetes are not consuming sufficiently healthy diets and could benefit from ongoing nutritional education and counseling, according to a new study by researchers at Wake Forest University School of Medicine and colleagues.

4 Sep 2009

China Aoxing submits an NDA to the China SFDA for its Codeine Phosphate

China Aoxing Pharmaceutical Company, Inc. (OTCBB: CAXG) ("China Aoxing"), a pharmaceutical company specializing in research, development, manufacturing and marketing of narcotic and pain-management products, today announced that it has submitted a new drug application (NDA) to the China State Food and Drug Administration (SFDA) for its Codeine Phosphate, a compound oral solution for the treatment of acute moderate to severe cough.

3 Sep 2009

China Sky One Medical submits application to perform clinical trials for two new generic drugs

China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that the Company has finished the required research for two new generic drugs for eye treatment and submitted application to the State Food and Drug Administration (SFDA) in China to perform clinical trials.

3 Sep 2009

Criminal pricing of Merck’s HIV/AIDS drug Isentress challenged by the AIDS Healthcare Foundation

As part of its ongoing campaign to lower drug prices and increase access, AIDS Healthcare Foundation (AHF) today unveiled its latest advocacy campaign challenging Merck and Co. Pharmaceuticals over the steep price of its key HIV/AIDS drug, Isentress (raltegravir). The first phase of the public awareness campaign includes a postcard mailer, scheduled to arrive this week in the mailboxes of residents of Whitehouse Station, New Jersey, where Merck is headquartered.

3 Sep 2009

RCN to partner with University of Illinois Medical Center for Fall Rush campaign

RCN Corporation, a leading provider of all-digital and high definition video, high-speed internet, and premium voice services to residential and small-medium business customers, as well as high-capacity transport services to carrier and large enterprise customers, announced today it will partner with the University of Illinois Medical Center as part of its Fall Rush campaign.

3 Sep 2009

Consumers seek functional foods and supplements to enhance wellness quotient

An expanding aging population and increased consumer awareness boosts growth for the U.S. bone and joint health ingredients market. Consumers increasingly seek supplements and functional foods that enhance their wellness quotient and have strong scientific backup.

3 Sep 2009

Ethical Alternative Products launches the OmniFlex joint support formula

Ethical Alternative Products has launched OmniFlex, a unique joint support formula combining five highly researched ingredients shown specifically to positively impact joint structure and function in easy-to-swallow soft-gel capsules.

3 Sep 2009