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Boston Scientific receives FDA clearance to resume distribution of COGNIS CRT-Ds and TELIGEN ICDs

Boston Scientific Corporation today announced that it has received U.S. Food and Drug Administration clearance for the two validated manufacturing changes affecting all of its cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators, and that it will immediately resume distribution of its COGNIS CRT-Ds and TELIGEN ICDs.

16 Apr 2010

FDA approves Akorn's ANDA for generic version of Dilaudid-HP Injection

Akorn, Inc. a niche generic pharmaceutical company, today announced that the U.S. Food and Drug Administration has granted approval of the Company's Abbreviated New Drug Application for the generic version of Dilaudid-HP® 10mg/ml Injection. The company intends to begin shipping the product next month.

16 Apr 2010

Nottingham and Japanese scientists to study genetic variation of E. coli bacteria

University of Nottingham scientists will join forces with Japan in the fight against a common bacterium - thanks to an international research award.

16 Apr 2010

Watson Laboratories' ANDA for generic Toprol XL tablets receives FDA approval

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc. - Florida, has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for metoprolol succinate extended-release tablets USP in the 100 and 200 mg strengths, the generic equivalent to AstraZeneca's Toprol XL® tablets.

16 Apr 2010

FAAN conference provides new insights about food allergies and anaphylaxis

The Food Allergy & Anaphylaxis Network (c) is bringing together parents, physicians, dietitians, caregivers, and others for its 17th Annual Food Allergy Conferences. The second of this year's four conferences will be held in Las Vegas and promises to give attendees new insights and strategies about food allergies and anaphylaxis.

16 Apr 2010

Obesity prejudice in medical community

Prejudice towards obese people is rife among trainee health professionals, but can be modified, new research has found.

16 Apr 2010

FDA publishes guidance to prevent Salmonella Enteritidis in shell eggs

On April 13, 2010, the U.S. Food and Drug Administration published guidance for small egg producers to help them comply with a 2009 federal egg safety regulation designed to prevent Salmonella Enteritidis in shell eggs during production, transportation, and storage.

16 Apr 2010

sBioMed's anthrax killing sterilant receives EPA approval

It has been nine years since the 2001 anthrax attacks sickened twenty-three people and killed five. Since that time, the U.S. government has spent hundreds of millions of dollars in remediation and billions in their search for a disinfectant that can reliably kill anthrax spores and other pathogens that might be used as weapons.

16 Apr 2010

Contura submits PMA for Aquamid

Contura Inc. has submitted a Premarket Approval Application for Aquamid to the U.S. Food and Drug Administration requesting marketing approval in the U.S. for the aesthetic treatment of moderate to severe facial wrinkles and folds.

16 Apr 2010

Æterna Zentaris Zentaris requests EMA Scientific Advice for Phase 3 program with perifosine

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that it has requested Scientific Advice from the European Medicines Agency (EMA) to assure the acceptability of the recently initiated Phase 3 programs for the development of its lead anticancer compound, perifosine, in its two lead indications, multiple myeloma and refractory advanced colorectal cancer.

15 Apr 2010

Mach One acquires White Hat Brands

Mach One Corporation, a global wellness solutions company, and White Hat Brands, LLC today announced the two companies have completed a definitive agreement whereby Mach One has acquired 100% interest in the fast-growing maker of kids' health and wellness beverages, including White Hat's top-seller Dog On It® Fortified Juice Beverages.

15 Apr 2010

Leading experts discuss health effects of low calorie sweeteners at BNF conference

A survey of over 2000 consumers carried out by YouGov on behalf of the British Nutrition Foundation shows that consumers are unsure about how low calorie sweeteners are used, whether they are beneficial for weight loss and whether they are safe.

15 Apr 2010

New computer simulation technique could speed up drug discovery process

Scientists here are taking the trial and error out of drug design by using powerful computers to identify molecular structures that have the highest potential to serve as the basis for new medications.

15 Apr 2010

Ibuprofen demonstrates efficacy over acetaminophen for treatment of pain and fever

Cumberland Pharmaceuticals Inc. today announced results from a meta-analysis comparing the efficacy and safety of ibuprofen and acetaminophen, which was published in the March edition of the peer-reviewed journal The Annals of Pharmacotherapy. The publication notes that in a majority of evaluated studies ibuprofen demonstrated superior efficacy compared to acetaminophen for the treatment of pain and fever, and found no significant safety differences between the drugs.

15 Apr 2010

Thermo Fisher Scientific opens global food testing laboratory in Dreieich, Germany

Thermo Fisher Scientific Inc., the world leader in serving science, today opened a global food testing laboratory devoted solely to helping contain costly and life-threatening chemical contamination crises. The Food Safety Response Center, located in Dreieich, Germany, is equipped with state-of-the-art equipment and staffed by world-class chemists who will quickly mobilize to aid governments and businesses facing an unknown food safety threat involving chemical contaminants.

From Thermo Fisher Scientific Inc. 15 Apr 2010

Fast foods contain insufficient iodine content, says new research

With one in four Americans reportedly consuming fast food on a daily basis, new research which will be released on Thursday, April 22nd at the American Association of Clinical Endocrinologists (AACE) 19th Annual Meeting & Clinical Congress indicating another reason to avoid fast food; It may also be lacking in appropriate amounts of iodine.

15 Apr 2010

GBS cases reduce following 2009 H1N1 vaccination: Research study

A new study finds that reports of a neurologic disease called Guillain-Barré syndrome have been low after 2009 H1N1 vaccination, according to a research study that will be presented as part of the late-breaking science program at the American Academy of Neurology's 62nd Annual Meeting in Toronto, April 10 - 17, 2010.

15 Apr 2010

John Muir Physician Network to participate in Generex Oral-lyn FDA Expanded Access Treatment IND program

Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, today announced that John Muir Physician Network Clinical Research Center has agreed to participate in the United States Food and Drug Administration (FDA) Expanded Access Treatment Investigational New Drug (IND) Program for the Company's flagship product, Generex Oral-lyn™, a proprietary buccal insulin spray product.

15 Apr 2010

FDA: Seven MDIs for treating asthma and COPD to be phased out

The U.S. Food and Drug Administration today announced, in accordance with longstanding U.S. obligations under the Montreal Protocol on Substances that Deplete the Ozone Layer, seven metered-dose inhalers (MDI) used to treat asthma and chronic obstructive pulmonary disease (COPD) will be gradually removed from the U.S. marketplace. These inhalers contain ozone-depleting chlorofluorocarbons (CFCs), which are propellants that move medication out of the inhaler and into the lungs of patients.

15 Apr 2010

Combivent Inhalation Aerosol's "essential use" status effective through 2013

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) today announced that the U.S. Food and Drug Administration (FDA) has determined that the "essential use" status of Combivent® (ipratropium bromide and albuterol sulfate) Inhalation Aerosol will be effective through December 31, 2013. With this ruling, COMBIVENT will remain on the market and available to the more than two million chronic obstructive pulmonary disease (COPD) patients who rely on it as a bronchodilator.

15 Apr 2010