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Impax initiates challenge of patents relating to WELCHOL

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) for Oral Suspension, 3.75 gm/packet and 1.875 gm/packet.

22 Nov 2010

FDA grants Impax tentative approval for generic Cymbalta NDA

Impax Laboratories, Inc. confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Cymbalta® delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules.

22 Nov 2010

Grifols launches Flebogamma 10% DIF intravenous immune globulin in the U.S.

Grifols today announced availability of its recently approved Flebogamma® 10% DIF intravenous immune globulin. Grifols is a global healthcare company specializing in bioscience medicines derived from human plasma. Approval from the US Food and Drug Administration (FDA) for Flebogamma® 10% DIF was obtained in July 2010 and final approval in Europe is expected before the end of the year. Today's announcement signals widespread product availability to the US market.

22 Nov 2010

Spectral enters distribution agreement with Toray to market TORAYMYXIN in Canada

Spectral Diagnostics Inc., today announced that it has signed a long-term, exclusive distribution agreement with Toray Industries, Inc. and Toray Medical Co., Ltd. of Japan (collectively "Toray") to market and sell Toraymyxin™ in Canada. Toraymyxin™ is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. This product and Spectral's EAA™ diagnostic, which measures endotoxin and identifies patients for treatment, are already approved for sale by Health Canada.

22 Nov 2010

Convergence enters drug discovery collaboration with Selcia for chronic pain treatment

Convergence Pharmaceuticals Limited, the new company focused on the development of novel and high value analgesic medicines, and Selcia Limited, a contract research organisation, today are pleased to announce that they have entered into a drug discovery collaboration to identify and develop high quality candidate molecules for the treatment of chronic pain.

22 Nov 2010

Best Practices study: Mock review helps effective approach for preparing team for NDA advisory committee meeting

Pharmaceutical companies with good track records of approvals and first approvals are characterized not only by strong science but also strong working relationships with the FDA. Regulatory Affairs is the function that oversees and guides interactions with the FDA it's a job that comes with a plethora of responsibilities related to New Drug Applications (NDA).

20 Nov 2010

Surveyed cardiologists, PCPs perceive Crestor comparable to Lipitor in ability to reduce mortality

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that in the treatment of dyslipidemia, surveyed cardiologists and primary care physicians (PCPs) now perceive AstraZeneca's Crestor's ability to reduce mortality comparable to Pfizer's Lipitor. This finding has changed from Decision Resources' 2009 analysis in which surveyed cardiologists viewed Lipitor as significantly better on this end point.

20 Nov 2010

Vical to present results of Vaxfectin adjuvant at Conference in Hungary

Vical Incorporated today announced that the company is presenting an overview of results for its patented Vaxfectin adjuvant at the Modern Veterinary Vaccines & Adjuvants conference.

20 Nov 2010

Xanodyne to withdraw propoxyphene-containing products from the U.S. market

Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon, Darvon-N and Darvocet-N products from the U.S. market in consultation with the U.S. Food and Drug Administration (FDA).

20 Nov 2010

Quercetin in Gene-Eden may be beneficial against flu virus: Research

Recently, researchers discovered that quercetin, a key ingredient in the natural antiviral supplement Gene-Eden, may be beneficial against the flu virus.

20 Nov 2010

Appeals Court stays judgment in Marine Polymer's patent infringement case against HemCon

HemCon Medical Technologies, Inc., announced today that the U.S. Court of Appeals for the Federal Circuit granted HemCon's motion to stay the injunction and final judgment (including the damages award) obtained against it in a patent infringement case brought by Marine Polymer Technologies, Inc.

20 Nov 2010

Psychiatric hospitalization rate decreases among adults with schizophrenia treated with INVEGA SUSTENNA: Study

Schizophrenia is a chronic and disabling brain disorder that affects 1 percent of the U.S. population and results in substantial medical and societal costs, in particular from use of health-care resources. It also can have devastating health-related and social effects on people with the disease, their families and caregivers.

20 Nov 2010

NEXTERONE Premixed Injection uses CyDex Captisol technology platform

CyDex Pharmaceuticals, Inc. today announced that Prism Pharmaceuticals' NEXTERONE (amiodarone HCL) Premixed Injection, which recently received supplemental new drug application (sNDA) approval from the U.S. Food and Drug Administration, makes use of the patent-protected CyDex Captisol technology platform.

20 Nov 2010

Xanodyne Pharmaceuticals decides to voluntarily remove propoxyphene from the U.S. market

Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne's decision and requested that they voluntarily remove their products as well.

20 Nov 2010

NexACT technology improves oral delivery of five small molecule drugs

Apricus Biosciences, Inc., today announced data from animal studies showing that the NexACT technology significantly improved the oral delivery of five small molecule drugs tested, with the best improvements up to 20-fold, in terms of improvement in absorption.

20 Nov 2010

Merck wins third FOSAMAX bellwether trial

Merck & Co., Inc. today said a federal court jury in New York found in its favor in the Graves v. Merck case, rejecting the claims of a Florida woman who blamed her dental and jaw related problems on her FOSAMAX use. With today's verdict, Merck has won three of the first four bellwether cases in the FOSAMAX litigation.

20 Nov 2010

FDA-approved anti-parasite drug blocks Wnt signaling pathway in colon cancer

An old pinworm medicine is a new lead in the search for compounds that block a signaling pathway implicated in colon cancer. The findings, reported by Vanderbilt University Medical Center researchers in the November issue of Nature Chemical Biology, suggest a fresh approach for developing therapeutics that target the pathway.

20 Nov 2010

Antares advances VIBEX QS platform for highly-viscous drug injection

Antares Pharma, Inc., a leader in self-injection drug delivery technology, today announced the latest advancement in its proprietary line of VIBEX auto-injectors.

20 Nov 2010

Xgeva receives FDA approval for prevention of SREs in patients with bone metastases

The U.S. Food and Drug Administration approved Xgeva (denosumab) on Thursday to help prevent skeletal-related events (SREs) in patients with cancer that has spread (metastasized) and damaged the bone. Skeletal-related events include bone fractures from cancer and bone pain requiring radiation.

19 Nov 2010

Cough suppressant syrup may predict patients metabolise tamoxifen in breast cancer treatment

Cough medicine could be used as way of predicting how well individual patients metabolise tamoxifen used in the treatment of their breast cancer, according to new research presented at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Berlin today

19 Nov 2010

Pharmaceutical News

Impax initiates challenge of patents relating to WELCHOL

FDA grants Impax tentative approval for generic Cymbalta NDA

Grifols launches Flebogamma 10% DIF intravenous immune globulin in the U.S.

Spectral enters distribution agreement with Toray to market TORAYMYXIN in Canada

Convergence enters drug discovery collaboration with Selcia for chronic pain treatment

Best Practices study: Mock review helps effective approach for preparing team for NDA advisory committee meeting

Surveyed cardiologists, PCPs perceive Crestor comparable to Lipitor in ability to reduce mortality

Vical to present results of Vaxfectin adjuvant at Conference in Hungary

Xanodyne to withdraw propoxyphene-containing products from the U.S. market

Quercetin in Gene-Eden may be beneficial against flu virus: Research

Appeals Court stays judgment in Marine Polymer's patent infringement case against HemCon

Psychiatric hospitalization rate decreases among adults with schizophrenia treated with INVEGA SUSTENNA: Study

NEXTERONE Premixed Injection uses CyDex Captisol technology platform

Xanodyne Pharmaceuticals decides to voluntarily remove propoxyphene from the U.S. market

NexACT technology improves oral delivery of five small molecule drugs

Merck wins third FOSAMAX bellwether trial

FDA-approved anti-parasite drug blocks Wnt signaling pathway in colon cancer

Antares advances VIBEX QS platform for highly-viscous drug injection

Xgeva receives FDA approval for prevention of SREs in patients with bone metastases

Cough suppressant syrup may predict patients metabolise tamoxifen in breast cancer treatment

Advancing brain microphysiological systems (bMPS)

PhD researcher at LifeArc

Unveiling Hidden Potential: Organoids for Disease Modeling in Neuroscience Research

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