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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

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

Genzyme Corporation announced today that the FDA has granted U.S. marketing approval for Lumizyme™ (alglucosidase alfa), produced at the 4000 liter (L) bioreactor scale at its manufacturing facility in Geel, Belgium. Lumizyme is the first treatment approved in the United States specifically to treat patients with late-onset Pompe disease.

25 May 2010

HHS 'special mailing' on health law's immediate Medicare benefits sparks GOP grumbles

CQ HealthBeat: "Education or propaganda? Or 'beyond propaganda?' The Centers for Medicare and Medicaid Services announced Monday that it will soon send Medicare beneficiaries a special mailing on 'the immediate benefits they may see' from the health care overhaul law. Getting accurate information about key provisions of the law will help Medicare enrollees 'to be on the alert for any scams asking for personal information,' explained acting CMS Administrator Marilyn Tavenner in an agency news release Monday.

25 May 2010

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Alkermes, Inc. today announced that the supplemental New Drug Application (sNDA) for VIVITROL® (naltrexone for extended-release injectable suspension) for opioid dependence has been designated a priority review by the U.S. Food and Drug Administration (FDA).

25 May 2010

Consumer Reports Health rates four spray-on sunscreens

Memo to beach bums: get ready to pump it and spray it, and don't apply it in the wind. New tests of sunscreens by Consumer Reports Health reveal that four spray-on sunscreens provided the best protection from the sun's Ultraviolet A (UVA) and Ultraviolet B (UVB) rays. The ratings are available in the July issue of the magazine. The magazine also looks at insect repellents. Both articles are available in Spanish on www.consumerreportsenespanol.org.

25 May 2010

USPTO issues composition of matter patent for Transave's ARIKACE

Transave Inc. today announced that the United States Patent and Trademark Office has issued an important composition of matter patent (U.S. Patent No. 7,718,189) for liposomal aminoglycoside formulations including its lead compound, ARIKACE™ (liposomal amikacin for inhalation). The company expects that the patent will provide exclusivity for ARIKACE until October 1, 2026.

25 May 2010

Vical receives $4.0M grant to support development of novel vaccine for CMV infection

Vical Incorporated announced today that the company is collaborating with leading pediatric infectious disease researchers Stuart P. Adler, M.D., and Michael A. McVoy, Ph.D., of Virginia Commonwealth University under a five-year, approximately $4.0 million grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

25 May 2010

Folate supplementation thwarts heart birth defects induced by alcohol exposure in early pregnancy

A new animal study has found that high levels of the B-vitamin folate (folic acid) prevented heart birth defects induced by alcohol exposure in early pregnancy, a condition known as fetal alcohol syndrome.

25 May 2010

Pharmaceutical News

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

Genzyme's Lumizyme for Pompe disease receives FDA marketing approval

HHS 'special mailing' on health law's immediate Medicare benefits sparks GOP grumbles

FDA grants priority review for Alkermes' VIVITROL sNDA for opioid dependence

Consumer Reports Health rates four spray-on sunscreens

USPTO issues composition of matter patent for Transave's ARIKACE

Vical receives $4.0M grant to support development of novel vaccine for CMV infection

Folate supplementation thwarts heart birth defects induced by alcohol exposure in early pregnancy

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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