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Perrigo acquires rights to ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit

Perrigo Company today announced that it has acquired rights to Novel Laboratories' pending ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution and bisacodyl delayed-release tablets), indicated for the cleansing of the colon as a preparation for colonoscopy in adults.

26 May 2010

FDA approves Mylan's ANDA for Valacyclovir Hydrochloride Tablets

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Valacyclovir Hydrochloride Tablets, 500 mg (base) and 1000 mg (base), the generic version of GlaxoSmithKline's Valtrex, a treatment for the herpes virus infection.

26 May 2010

A step closer to a universal influenza virus vaccine

Researchers at Mount Sinai School of Medicine have developed a new influenza vaccine that brings science one step closer to a universal influenza vaccine that would eliminate the need for seasonal flu shots. The new findings can be found in the inaugural issue of mBio-, the first online, open-access journal published by the American Society for Microbiology.

26 May 2010

IMC announces "Commitment to Compliance" initiative in response to FDA's "Bad Ad Program"

Informed Medical Communications (IMC), a leading full-service provider of peer-to-peer medical forums and integrated medical communications for the bio-pharmaceutical industry, today announced its "Commitment to Compliance" initiative, responding to the FDA's new program to minimize misleading drug advertising and promotion.

26 May 2010

Report: 235 new medicines in development to treat diabetes

A record 235 new medicines to treat diabetes, one of the fastest-growing diseases in America, are being developed by America's pharmaceutical research and biotechnology companies, according to a national report unveiled today in Charleston.

26 May 2010

Lyophilized heparin demonstrates better ability to preserve cord blood stem cells than CPD: Study

Lyophilized heparin, a proprietary anticoagulant developed specifically for cord blood collection, demonstrated a better ability to preserve the number of viable cells over a longer period of time than a commonly-used anticoagulant, citrate phosphate dextrose, according to a study presented today at the International Society for Cellular Therapy Annual Meeting.

26 May 2010

Ambrotose AO capsules raise antioxidant protection in serum ORAC in healthy adults: Study

Mannatech, Incorporated, a global pioneer in the development of high-quality health, weight and fitness, and skin care solutions based on nutritional science, announced the results of an independent human clinical study that demonstrated intake of its proprietary Ambrotose AO capsules raised antioxidant protection in serum oxygen radical absorbance capacity in healthy adults, further validating a previous human study.

26 May 2010

Antiviral treatment, SVR prevent esophageal varices in patients with HCV-induced cirrhosis

Italian researchers have discovered that antiviral treatment and sustained virologic response prevents esophageal varices in patients with compensated hepatitis C -induced cirrhosis, indicating that endoscopic surveillance can be safely delayed or avoided in these patients. Full findings are published in the June issue of Hepatology, a journal of the American Association for the Study of Liver Diseases.

26 May 2010

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

POZEN Inc., announced today the receipt of a $20 million milestone payment from AstraZeneca for the U.S. Food and Drug Administration approval of VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets on April 30th. POZEN will transfer ownership of the Investigational New Drug application and New Drug Application for VIMOVO to AstraZeneca over the next few weeks.

26 May 2010

Cobalis submits Form of Order with US Bankruptcy Court

Cobalis Corp announced today that the Company's attorneys have submitted a Form of Order consistent with the United States Bankruptcy Court's ruling of April 7, 2010 confirming the debtor's plan of reorganization.

26 May 2010

Positive results from 3 year follow-up of BPH patients treated with NX-1207 in Study NX02-0016

Nymox Pharmaceutical Corporation is pleased to report positive new results from the 30-36 month follow-up study of patients treated with NX-1207 in Study NX02-0016. The initial study, completed in the U.S. in 2007, reached statistical significance in Intent-to-Treat Primary Efficacy outcomes at 90 days and 6 months post-treatment with NX-1207 2.5 mg.

26 May 2010

Researchers present more findings for microbicides, prep at M2010 conference

Researchers on Monday at the International Microbicides Conference in Pittsburgh continued to present data on HIV prevention research, Reuters reports. The news service outlines several prevention methods being researched, including an intravaginal ring that over time releases two antiretrovirals - dapivirine and maraviroc - for up to a month, and a vaginal tablet that time-releases the antiretrovirals dapivirine and DS003 for up to 12 hours.

26 May 2010

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Shire plc, the global specialty biopharmaceutical company, today announced the results of a study evaluating the safety and efficacy of Vyvanse (lisdexamfetamine dimesylate) Capsules CII for the treatment of Attention Deficit Hyperactivity Disorder in adolescents aged 13 to 17 years.

26 May 2010

Academic researchers say tour yielded 23 percent increase in patients who got best, cheapest drugs

Reuters reports that 150 academic researchers touring the U.S. to make recommendations on diuretics and best and cheapest practices for blood pressure medicine have reported a 23 percent increase in patients who get the recommended drugs, "twice the increase in the U.S. over the same period."

26 May 2010

$FDA warns on possible fracture risk with proton pump inhibitors use$

FDA warns on possible fracture risk with proton pump inhibitors use

The U.S. Food and Drug Administration today warned consumers and health care professionals about a possible increased risk of fractures of the hip, wrist, and spine with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk.

26 May 2010

Experts warn increasing IDUs in eastern, southern Africa could threaten HIV/AIDS fight

An increase in the number of injection drug users (IDUs) in eastern and southern Africa stands to harm efforts to control the spread of HIV/AIDS in the region, warned experts gathered at the World Forum Against Drug conference in Sweden on Monday, Agence France-Presse reports.

26 May 2010

Lumizyme receives FDA approval for patients with late-onset Pompe disease

The U.S. Food and Drug Administration approved Lumizyme (alglucosidase alfa) for patients ages 8 years and older with late-onset (non-infantile) Pompe disease, a rare genetic disorder.

26 May 2010

Researchers examine association between use of antibiotics and outcomes among patients with COPD

Among patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease, those who received antibiotics in the first 2 hospital days had improved outcomes, such as a lower likelihood of mechanical ventilation and fewer readmissions, compared to patients who received antibiotics later or not at all, according to a study in the May 26 issue of JAMA.

26 May 2010

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market sevelamer carbonate 800mg tablets. Watson's sevelamer carbonate tablet is the generic version of Genzyme's Renvela®. Renvela ® is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease who are on dialysis.

26 May 2010

Mylan Pharmaceuticals introduces Temazepam Capsules USP, 7.5 mg

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Temazepam Capsules USP, 7.5 mg.

25 May 2010

Pharmaceutical News

Perrigo acquires rights to ANDA for HalfLytely and Bisacodyl Tablets Bowel Prep Kit

FDA approves Mylan's ANDA for Valacyclovir Hydrochloride Tablets

A step closer to a universal influenza virus vaccine

IMC announces "Commitment to Compliance" initiative in response to FDA's "Bad Ad Program"

Report: 235 new medicines in development to treat diabetes

Lyophilized heparin demonstrates better ability to preserve cord blood stem cells than CPD: Study

Ambrotose AO capsules raise antioxidant protection in serum ORAC in healthy adults: Study

Antiviral treatment, SVR prevent esophageal varices in patients with HCV-induced cirrhosis

POZEN receives milestone payment from AstraZeneca for FDA approval of VIMOVO

Cobalis submits Form of Order with US Bankruptcy Court

Positive results from 3 year follow-up of BPH patients treated with NX-1207 in Study NX02-0016

Researchers present more findings for microbicides, prep at M2010 conference

Shire announces study results of Vyvanse Capsules CII for treatment of ADHD in adolescents

Academic researchers say tour yielded 23 percent increase in patients who got best, cheapest drugs

FDA warns on possible fracture risk with proton pump inhibitors use

Experts warn increasing IDUs in eastern, southern Africa could threaten HIV/AIDS fight

Lumizyme receives FDA approval for patients with late-onset Pompe disease

Researchers examine association between use of antibiotics and outcomes among patients with COPD

Genzyme's suit stays final FDA approval of Watson's generic Renvela ANDA

Mylan Pharmaceuticals introduces Temazepam Capsules USP, 7.5 mg

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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