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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

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

Salix Pharmaceuticals, Ltd. today announced the availability of Xifaxan (rifaximin) 550 mg tablets for the reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. Those HE patients may now fill their Xifaxan 550 mg prescriptions in U.S. pharmacies and should speak with their doctors about this important treatment option.

24 May 2010

Ortho-McNeil Pharmaceutical pleads guilty for promoting epilepsy drug Topamax for psychiatric use

Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson, pled guilty today in U.S. District Court in Boston to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. The company was also sentenced at today's hearing.

24 May 2010

Filing of Clinical Data's NDA for vilazodone accepted for FDA review

Clinical Data, Inc., today announced that the U.S. Food and Drug Administration has accepted for filing the Company's New Drug Application for vilazodone for the treatment of major depressive disorder.

24 May 2010

NCC receives $25,000 grant award from Hospira Foundation to support pharmaceutical relief program

The National Cancer Coalition is pleased to announce that it recently received a $25,000 grant award from the Hospira Foundation, the philanthropic arm of Hospira, Inc., to support its pharmaceutical relief program within the Dominican Republic. NCC is seeking to significantly increase the levels of medical resources that it provides to the public hospitals of the Dominican Republic in an effort to more fully treat the country's underserved patients, and this grant will contribute toward achieving that goal.

24 May 2010

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

Shire plc, the global specialty biopharmaceutical company, today announced new findings on once-daily INTUNIV (guanfacine) Extended Release Tablets, the first selective alpha-2A agonist approved for the treatment of Attention Deficit Hyperactivity Disorder, at a major psychiatric meeting.

24 May 2010

New therapies can turn cancer into chronic disease

Two new studies suggest that the prolonged use of cancer drugs helped stunt the progress of the disease, a shift from the scheduled courses of treatment typically delivered to patients, The Wall Street Journal reports.

24 May 2010

Pharmaceutical News

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

Salix Pharmaceuticals announces availability of Xifaxan tablets for reducing risk of overt HE recurrence

Ortho-McNeil Pharmaceutical pleads guilty for promoting epilepsy drug Topamax for psychiatric use

Filing of Clinical Data's NDA for vilazodone accepted for FDA review

NCC receives $25,000 grant award from Hospira Foundation to support pharmaceutical relief program

New findings on INTUNIV Extended Release Tablets presented at major psychiatric meeting

New therapies can turn cancer into chronic disease

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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