Generic Drug News and Research

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Generic Drugs are official nonbrand names by which medicines are known. Generic names usually refer to the chemical name of the drug.

Akorn's consolidated revenue for fourth quarter 2013 increases 19% to $85 million

Akorn, Inc., a niche generic pharmaceutical company, today reported financial results for the fourth quarter and year-ended December 31, 2013.

3 Mar 2014

Viewpoints: The evolution of Medicare; generic drugs and patient safety; new food labels

About half a century ago, organized medicine and the hospital industry in this country struck a deal with Congress that in retrospect seems as audacious as it seems incredible: Congress was asked to surrender to these industries the keys to the United States Treasury. In return, the industries would allow Congress to pass a 1965 amendment to the Social Security Act .... We have come to know it as Medicare.

3 Mar 2014

First Edition: February 18, 2014

Kaiser Health News staff writer Jay Hancock, working in collaboration with USA Today, reports: "Congratulations. You bought insurance through one of the online Affordable Care Act exchanges, possibly after days or weeks of trying to get the site to work. Don't relax. Joining the plan is only the first challenge. Now you have to understand it. Policies sold through the online portals -- to more than 3 million people so far -- cover essential benefits and put a cap on your out-of-pocket medical costs. But you need to follow the rules" (Hancock, 2/17).

18 Feb 2014

FDA grants full approval of SYNRIBO for injection

Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration has granted full approval of SYNRIBO (omacetaxine mepesuccinate) for injection. This oncology portfolio product received an accelerated approval in October, 2012 with additional clinical trial data required to fulfill post marketing requirements set forth by the FDA.

13 Feb 2014

Cambrex fourth quarter sales increase 46.3% to $103 million

Cambrex Corporation reports results for the fourth quarter and full year ended December 31, 2013.

11 Feb 2014

FDA approves Teva's sNDA for three-times-a-week COPAXONE 40mg/mL

Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has approved the Company's supplemental new drug application for three-times-a-week COPAXONE 40mg/mL, a new dose of COPAXONE.

28 Jan 2014

Myelin Repair Foundation enters into agreement with NIH to assess MRF-008 for multiple sclerosis

The Myelin Repair Foundation today announced it has entered a Cooperative Research and Development Agreement with the National Institutes of Health to assess MRF-008, as a potential therapeutic for multiple sclerosis. This CRADA will facilitate collaboration between the MRF and National Institute of Neurological Disorders and Stroke at the NIH Clinical Center to study MRF-008, a drug identified by the MRF as a potential neuroprotective therapeutic to enhance repair in multiple sclerosis patients.

27 Jan 2014

Active Biotech, Teva remain committed to NERVENTRA clinical development program for multiple sclerosis

Teva Pharmaceutical Industries Ltd. and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today that both companies remain committed to the NERVENTRA® (laquinimod) clinical development program for multiple sclerosis (MS) following the announcement of a negative opinion for the treatment of relapsing-remitting multiple sclerosis (RRMS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

27 Jan 2014

CMS report shows slower growth in health spending with the Affordable Care Act implementation

Today, the Centers for Medicare and Medicaid Services issued findings that show slower growth in health spending since the implementation of the Affordable Care Act. This successful cost control is consistent with data demonstrating that savings from generic medicines are at an all-time high, reaching $217 billion in 2012 and $1.2 trillion over the most recent decade, according to the 2013 Report on Generic Drug Savings in the U.S., the fifth annual report compiled by IMS Health on behalf of the Generic Pharmaceutical Association.

7 Jan 2014

Teva Pharmaceuticals sells 31 generic drug products to ANI Pharmaceuticals

ANI Pharmaceuticals, Inc., an emerging generic pharmaceutical company, today announced that it has acquired 31 previously marketed generic drug products from Teva Pharmaceuticals for $12.5 million in cash and a percentage of future gross profits from product sales.

27 Dec 2013

Diflunisal drug reduces neurological decline in patients with familial transthyretin amyloidosis

A recent study led by researchers from the Amyloidosis Center at Boston University School of Medicine and Boston Medical Center demonstrates that diflunisal, a generic anti-inflammatory drug, successfully reduced neurological decline and preserved the quality of life in patients with familial transthyretin amyloidosis. Diflunisal is an inexpensive and safe medication marketed over the past 40 years for arthritis and pain.

25 Dec 2013

Epilepsy experts discuss on new NTI definition, bioequivalence guidelines at AES annual meeting

For several years, epilepsy practitioners have questioned the U.S. Food and Drug Administration's definition of bioequivalence as it applies to narrow therapeutic index drugs, such as those used for epilepsy. In response to these concerns, the FDA has sponsored 3 studies of antiepileptic drugs and also convened an advisory board to help determine which drugs are NTI.

10 Dec 2013

Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

Teva Pharmaceutical Industries Ltd. and Takeda Pharmaceutical Company Limited (Takeda) today announced the signing earlier this year of an agreement in which Teva licensed to Takeda the right to commercialize Teva's innovative glatiramer acetate ( active ingredient) formulation for the treatment of multiple sclerosis, in Japan.

4 Dec 2013

Researchers discover how type 2 diabetes drug metformin actually works

Researchers from St. Vincent's Institute of Medical Research in Melbourne, Australia, in collaboration with researchers at McMaster University in Canada, are reportedly the first to discover how the type 2 diabetes drug metformin actually works, providing a molecular understanding that could lead to the development of more effective therapies. Mass spectrometry technologies from AB SCIEX, a global leader in analytical technologies, played a critical role in the analysis that led to this breakthrough finding.

25 Nov 2013

FDA proposes change in generic drug makers' labels

The change would allow generic manufacturers to put new safety information on the labels without having to get FDA permission.

12 Nov 2013

First Edition: November 11, 2013

Today's headlines include reports about how Republicans are positioning themselves to capitalize on the health law's implementation difficulties in the upcoming election season.

11 Nov 2013

FDA proposes rule to speed dissemination of new safety information about generic drugs

A proposed U.S. Food and Drug Administration rule would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.

11 Nov 2013

Genovate, ScinoPharm to jointly develop new-generation oral Hepatitis B drug Livepro

Genovate Biotechnology Co. Ltd. and ScinoPharm Taiwan Ltd. announced today that they have jointly developed the highly potent oral generic drug Livepro (Entecavir), representing a new generation of drugs for the treatment of Hepatitis B. It is expected to be commercially available by the end of the year in Taiwan, accounting for more than NT$2 billion (US$70 million) worth of market opportunity.

11 Nov 2013

Generic drug gabapentin appears to be safe, effective in treating alcohol dependence

The generic drug gabapentin, which is already widely prescribed for epilepsy and some kinds of pain, appears to be safe and effective in the treatment of alcohol dependence. The finding comes from a 150-patient randomized, placebo-controlled, double blind clinical trial conducted by scientists at The Scripps Research Institute.

4 Nov 2013

Researchers study quality, effectiveness and safety of generic drugs used to treat depression

Researchers at Washington University School of Medicine in St. Louis are studying the quality, effectiveness and safety of generic drugs used to treat depression.

4 Nov 2013

Generic Drug News and Research

Further Reading

Akorn's consolidated revenue for fourth quarter 2013 increases 19% to $85 million

Viewpoints: The evolution of Medicare; generic drugs and patient safety; new food labels

First Edition: February 18, 2014

FDA grants full approval of SYNRIBO for injection

Cambrex fourth quarter sales increase 46.3% to $103 million

FDA approves Teva's sNDA for three-times-a-week COPAXONE 40mg/mL

Myelin Repair Foundation enters into agreement with NIH to assess MRF-008 for multiple sclerosis

Active Biotech, Teva remain committed to NERVENTRA clinical development program for multiple sclerosis

CMS report shows slower growth in health spending with the Affordable Care Act implementation

Teva Pharmaceuticals sells 31 generic drug products to ANI Pharmaceuticals

Diflunisal drug reduces neurological decline in patients with familial transthyretin amyloidosis

Epilepsy experts discuss on new NTI definition, bioequivalence guidelines at AES annual meeting

Takeda and Teva announce agreement related to commercialization of glatiramer acetate in Japan

Researchers discover how type 2 diabetes drug metformin actually works

FDA proposes change in generic drug makers' labels

First Edition: November 11, 2013

FDA proposes rule to speed dissemination of new safety information about generic drugs

Genovate, ScinoPharm to jointly develop new-generation oral Hepatitis B drug Livepro

Generic drug gabapentin appears to be safe, effective in treating alcohol dependence

Researchers study quality, effectiveness and safety of generic drugs used to treat depression

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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