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Single shared REMS for TIRF products receives FDA approval

The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one system, easing the burden on the health care system.

30 Dec 2011

Avastin fails to live up to expectations for extending survival in ovarian cancer

Cancer drug Avastin has been found to add about four months to the time it takes for the cancer to worsen for women with advanced cases of ovarian cancer says a new report. However it may not extend survival significantly.

29 Dec 2011

Bevacizumab delays disease progression in ovarian cancer

Treating ovarian cancer with the drug bevacizumab ("Avastin") delays the disease and may also improve survival, show the results of an international clinical trial co-led by Drs. Amit Oza of the Princess Margaret Cancer Program, University Health Network and Timothy Perren, St James's Institute of Oncology, Leeds, UK.

29 Dec 2011

Powerful painkiller on its way to the market: Experts worry about addiction woes

Drug makers are on their way to a pure, more powerful version of the nation’s second most-abused medicine, which has addiction experts worried that it could spur a new wave of abuse. The new pills contain the highly addictive painkiller hydrocodone, packing up to 10 times the amount of the drug as existing medications such as Vicodin.

28 Dec 2011

Mylan receives final FDA approval for Levetiracetam ER Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Levetiracetam Extended-release (ER) Tablets, 500 mg and 750 mg.

28 Dec 2011

Mylan receives final FDA approval for Eprosartan Mesylate ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).

28 Dec 2011

Perrigo receives final approval from FDA for Desloratadine ANDA

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Desloratadine tablets.

27 Dec 2011

Eisai resubmits NDA for perampanel to treat epilepsy-associated seizures

Eisai Inc. announced today that it resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the U.S. Food and Drug Administration (FDA) on December 22, 2011.

26 Dec 2011

Synthetic drugs treat Crohn's disease in mice

A team of Weizmann Institute scientists has turned the tables on an autoimmune disease. In such diseases, including Crohn's and rheumatoid arthritis, the immune system mistakenly attacks the body's tissues. But the scientists managed to trick the immune systems of mice into targeting one of the body's players in autoimmune processes, an enzyme known as MMP9.

26 Dec 2011

AJHP examines pharmacists' prescribing medications in current issue

Pharmacists' prescribing medications is a topic often discussed when health policy experts explore how to improve patient safety, medication-use outcomes, and access to medical services.

26 Dec 2011

Wolters Kluwer sells pharma-related business to Springer Science+Business Media

Wolters Kluwer, a market-leading global information services company focused on professionals, today announced that it has completed the sale of its pharma-related Marketing & Publishing Services business to Springer Science+Business Media.

26 Dec 2011

FDA accepts Gilead's Quad HIV regimen NDA for review

Gilead Sciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for the Quad, a complete single-tablet HIV regimen containing elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.

26 Dec 2011

TheraBiogen launches Social Media campaign

TheraBiogen, Inc., a manufacturer and distributor of homeopathic nasal sprays for aiding in the relief of allergies, cold and flu symptoms and migraine headaches, announced today the launch of its Social Media campaign as part of its ongoing product marketing program.

26 Dec 2011

Researchers report how sildenafil can alleviate heart problems

How sildenafil, the active ingredient in Viagra, can alleviate heart problems is reported by Bochum's researchers in cooperation with colleagues from the Mayo Clinic in Rochester (Minnesota) in the journal Circulation.

26 Dec 2011

FDA EMDAC schedules to review VIVUS' Qnexa NDA for treatment of obesity

VIVUS, Inc. today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012.

26 Dec 2011

Researchers report how sildenafil can alleviate heart problems

23 Dec 2011

ARV drugs can prevent transmission of HIV

The finding of a team of researchers - including several members from Johns Hopkins - that HIV treatment with antiretroviral drugs (ARVs) can actually prevent transmission of the virus from an infected person to his or her uninfected partner has been named "Breakthrough of the Year" for 2011 by the journal Science.

23 Dec 2011

N.Y. Times review finds misuse of psychotropic drugs in disabled patients

Tens of thousands of powerful pills created to treat serious mental illnesses like schizophrenia are given to developmentally disabled people in the care of New York State every day.

23 Dec 2011

Injected meth users at greater risk of attempting suicide

The dire physical and mental health effects of injecting methamphetamine are well known, but there's been little research about suicidal behavior and injecting meth.

23 Dec 2011

Veloxis, Athena partner to establish competitive presence for AtorFen in emerging markets

Veloxis Pharmaceuticals and Athena Drug Delivery Solutions Pvt. Ltd. today announced an alliance whereby Athena will obtain exclusive rights in certain emerging market territories to manufacture and, with third parties, develop, register and commercialize Veloxis' AtorFen (Fenofibrate Atorvastatin fixed dose combination).

23 Dec 2011