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Jan. 25, 2005

Vol. 2 No. 17

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Calif. Lawmakers to Address Nine Prescription Drug Bills

A California state bill requiring drugmakers to turn over all safety and effectiveness data on every drug product sold in the state is part of a batch of Rx-related legislation that California lawmakers are scheduled to address this session.

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FOIA Direct Final Rule Withdrawn by FDA

The FDA has withdrawn a direct final rule to incorporate exemptions from the Freedom of Information Act (FOIA) into the agency's public information regulations because of what the agency called "significant adverse" comments from the public.

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FDA Panel Denies Merck's Application for OTC Mevacor

A joint panel of FDA advisers has recommended the agency not approve Merck's application to convert its cholesterol-lowering statin Mevacor from prescription to OTC status -- a move that will likely dampen efforts for OTC switches of other statins that are set to lose patent protection.

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FDA Approves Antidepressant Labeling, Sets 30-Day Deadline

The FDA has approved labeling revisions to antidepressants, clearing the way for drugmakers to add required "black box" warnings to their products to describe the increased risk of suicidal behavior in children and adolescents who take the drugs.

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Dharmacon RNAi Technology Selected to Support Drug Discovery Research

Dharmacon, the world's leading supplier of innovative RNA and RNA interference (RNAi) research products, has announced that Genentech has selected Dharmacon's advanced RNAi technology for use in its drug discovery and development research.

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Peregrine Gains Access to Merck KGaA's Protein Expression Technology

Peregrine Pharmaceuticals, a biopharmaceutical company with a broad portfolio of products under development, has entered into an agreement with Merck KGaA of Darmstadt, Germany, that will give Peregrine access to Merck's technology and expertise in protein expression.

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Li-Taka Enters Into Manufacturing Agreement With Wockhardt

Li-Taka Pharmaceuticals, a Pune-based Pharmaceutical Formulation Company, has recently entered into a manufacturing agreement with Wockhardt for manufacturing of Anti-TB range of products.

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CoTherix's Secondary Offering Could Pump New Blood Into Firm

CoTherix, strengthened by regulatory approval of its drug for pulmonary hypertension, filed a registration statement with the SEC for a 4 million-share offering.

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Greenhouse Funds to Aid 'High Risk, High Reward' Research

BioAdvance is set to unveil its third round of investments, which will provide roughly $3.5 million to seven local life sciences researchers or companies.

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Man Pleads Guilty in Illegal Lipitor Ring

A Miami man has pleaded guilty in federal court to his role in a multimillion dollar conspiracy to sell counterfeit and illegally imported Lipitor in the U.S. Julio Cesar Cruz, 42, pleaded guilty Friday in U.S. District Court in Kansas City to charges that he sold the counterfeit drugs and conspired to sell them between February 2002 and April 2003.

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PhytoMedical in Bio-Processing Agreement With Planta Analytica

PhytoMedical Technologies, an early-stage research-based biopharmaceutical company specializing in the discovery, development and eventual commercialization of innovative plant-derived pharmaceutical and nutraceutical compounds, has announced that Connecticut-based, Planta Analytica, will undertake the extraction, fractionation and isolation of potentially active pharmacological elements in PhytoMedical's BDC-03, a plant-derived compound that has been successful in reducing body fat percentage, increasing lean muscle mass and lowering cholesterol in studies of growing animals.

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