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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

Genzyme signs consent decree of permanent injunction, agrees to disgorgement

Genzyme Corp. has signed a consent decree agreeing to correct manufacturing quality violations at its Allston, Mass., manufacturing facility and will turn over to the federal government $175 million in unlawful profits from the sale of products that were made at the plant, the U.S. Food and Drug Administration announced today.

25 May 2010

Anti-aging supplements may prevent decline in physical function: Researchers

Anti-aging supplements made up of mixtures might be better than single compounds at preventing decline in physical function, according to researchers at the University of Florida's Institute on Aging. In addition, it appears that such so-called neutraceuticals should be taken before very old age for benefits such as improvement in physical function.

25 May 2010

Biogen Idec to join global MS community to commemorate the second annual World MS Day

On May 26, Biogen Idec will join the global multiple sclerosis community to commemorate the second annual World MS Day. Biogen Idec is a leader in the fight against MS, bringing hope to the thousands of patients across the globe who benefit from the company's MS therapies and ongoing research programs.

25 May 2010

ADDF provides $248,000 grant to ALSP to allow its lead drug candidate towards clinical trials

The Alzheimer's Drug Discovery Foundation announced today that it is providing a grant of $248,000 to American Life Science Pharmaceuticals, Inc. to allow for manufacture of its lead drug candidate to be used in preclinical toxicology testing in preparation for entering Phase I clinical trials early in 2011.

25 May 2010

Bayer's Adalat XL product and Mylan's nifedipine extended release 60 mg not bioequivalent: Study

Bayer Inc. today responded to Professor Marvin Meyer's letter to the editor, entitled: "Critical questions concerning the validity of the Bayer study report of differences in bioavailability between 60 mg of nifedipine osmotic push-pull systems after fasted and fed administration" and published in the online edition of the International Journal of Clinical Pharmacology and Therapeutics. Bayer responded to the clinical relevance of the differences in formulation and dissolution behaviour and the delayed absorption of Mylan's extended release nifedipine.

25 May 2010

Experts to discuss problem of drug production and trafficking in Afghanistan

The international forum "Drug Production in Afghanistan: A Challenge for the International Community" will be held in Moscow on June 9 and 10, 2010, at Russia's initiative.

25 May 2010

Genzyme finalizes terms for consent decree regarding Allston manufacturing plant

Genzyme Corporation announced today that the terms for the consent decree regarding the Allston manufacturing plant have been finalized. These terms are in line with the company's expectations announced last month. The consent decree is subject to approval by the United States District Court for the District of Massachusetts.

25 May 2010

Combination therapy improves patients with depression symptoms: Study

New data presented today at the American Psychiatric Association's annual meeting suggests a benefit to combining L-methylfolate, a prescription medical food called Deplin, with an antidepressant at the start of treatment. This retrospective analysis showed a significantly greater improvement in depression symptoms in a shorter period of time, when patients with Major Depressive Disorder were started on combination therapy.

25 May 2010

FDA approves Watson Pharmaceuticals' generic version of VALTREX tablets

Watson Pharmaceuticals, Inc., today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application for Valacyclovir Hydrochloride tablets, USP, in the 500 and 1000 mg strengths, the generic equivalent to GlaxoSmithKline, LLC's VALTREX tablets.

25 May 2010

Elite Pharmaceuticals acquires hydromorphone hydrochloride tablets from Mikah Pharma

Elite Pharmaceuticals, Inc. announced today the acquisition of a currently approved Abbreviated New Drug Application (ANDA) for hydromorphone hydrochloride 8 mg tablets from Mikah Pharma LLC. The hydromorphone hydrochloride tablets are the generic equivalent of Dilaudid® 8 mg.

25 May 2010

Beta-blocker medications provide new hope for patients with COPD: Study

Patients with chronic obstructive pulmonary disease may have fewer respiratory flare-ups and longer survival if they take beta-blocker medications, according to a report in the May 24 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

25 May 2010

Repligen's RG2833 granted orphan drug designation for treatment of Friedreich's ataxia

Repligen Corporation announced today that the Office of Orphan Products Development of the Food and Drug Administration has granted orphan drug designation to RG2833, a selective histone deacetylase 3 inhibitor for the treatment of Friedreich's ataxia. Orphan drug designation qualifies Repligen to receive seven years of marketing exclusivity in the United States if the company is the first to obtain marketing approval for RG2833 for the treatment of Friedreich's ataxia.

24 May 2010

Thymosin beta 4 reduces brain tissue damage, improves brain function in rats: Research paper

RegeneRx Biopharmaceuticals, Inc. announced today that in a preclinical research paper published in the May 2010 issue of the Journal of Neurosurgery, (online ahead of publication), scientists found that the systemic administration of thymosin beta 4, or Tβ4, significantly reduced brain tissue damage and improved brain function in rats with traumatic brain injury, or TBI.

24 May 2010

Pharmaceutical News

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

Genzyme signs consent decree of permanent injunction, agrees to disgorgement

Anti-aging supplements may prevent decline in physical function: Researchers

Biogen Idec to join global MS community to commemorate the second annual World MS Day

ADDF provides $248,000 grant to ALSP to allow its lead drug candidate towards clinical trials

Bayer's Adalat XL product and Mylan's nifedipine extended release 60 mg not bioequivalent: Study

Experts to discuss problem of drug production and trafficking in Afghanistan

Genzyme finalizes terms for consent decree regarding Allston manufacturing plant

Combination therapy improves patients with depression symptoms: Study

FDA approves Watson Pharmaceuticals' generic version of VALTREX tablets

Elite Pharmaceuticals acquires hydromorphone hydrochloride tablets from Mikah Pharma

Beta-blocker medications provide new hope for patients with COPD: Study

Repligen's RG2833 granted orphan drug designation for treatment of Friedreich's ataxia

Thymosin beta 4 reduces brain tissue damage, improves brain function in rats: Research paper

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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