Lyrica is Pfizer’s trade name for a drug called pregabalin. Pregabalin is an anticonvulsant (anti-seizure) drug that is often used to treat neuropathic pain as well as partial seizures that are common in temporal lobe epilepsy. In Europe, pregabalin is also approved to treat generalized anxiety disorder. What does Lyrica treat? Lyrica or pregabalin has been approved in the U.S.
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Impax Laboratories, Inc. (NASDAQ: IPXL) confirmed that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s Abbreviated New Drug Application (ANDA) for generic versions of Precose® Tablets (acarbose), 25 mg, 50 mg and 100 mg strengths. Precose®, a Bayer HealthCare Pharmaceuticals product, is used in the management of type two diabetes mellitus.
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Regulatory processes differ across continents, posing challenges to drug launches. There is a pressing need to integrate the regulatory environment of the European Union (EU) and the U.S. Diverse regulations impact drug launches as less price controlled markets witness quicker launches, while it takes longer in regulated markets.
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Dainippon Sumitomo Pharma Co., Ltd., (DSP) announced today positive results from the first phase 3 clinical trial for lurasidone, which is under clinical development globally, for the treatment of patients with schizophrenia. In this six-week, double-blind, placebo-controlled trial, lurasidone 80 mg/day was significantly more effective than placebo for the treatment of acute schizophrenia. In addition, lurasidone was well-tolerated and had a relatively low discontinuation rate.
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Leading pharmaceutical and biotech companies are drawing on Singapore’s integrated network of public-sector and academic institutes to enhance their R&D productivity, leverage academic insights and diversify risks. Located at the heart of Asia with a population base that is representative of key Asian ethnic groups, Singapore provides a home-base of innovation for companies to test and develop new solutions for Asia and beyond.
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Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), an international biopharmaceutical company, announced that its subsidiary, Sucampo Pharma, Ltd., has initiated enrollment and completed the randomization of the first patient into the pivotal phase 3 efficacy trial of lubiprostone for chronic idiopathic constipation (CIC) in Japan. Under the terms of a license, commercialization and supply agreement Sucampo signed in February 2009 with Abbott Japan Co., Ltd.
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Otsuka Pharmaceutical Co., Ltd. (OPC) and Otsuka Pharmaceutical Development and Commercialization, Inc. (OPDC) announced that the U.S.
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Investigators from the Phase III TRITON-TIMI 38 study applied the new classification system for the Universal Definition of Myocardial Infarction to the results of the study and showed that patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI) and taking
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Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, announced today the presentation of two posters at the 2009 annual meeting of the American Psychiatric Association in San Francisco, California.
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Eli Lilly and Company (NYSE: LLY) announced it will begin enrolling patients this month in two separate but identical Phase III clinical trials of solanezumab(i), previously referred to as LY2062430, an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer’s disease.
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