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Fdanewsdrugdailybulletin

Jan. 19, 2005

Vol. 2 No. 13

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FDA ISSUES DRAFT GUIDANCE FOR OTC HUMAN-DRUG LABELING

The FDA has published a draft guidance to provide drugmakers with recommendations on how to convert OTC drug monograph labeling to OTC "Drug Facts" format.

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FDA ISSUES WARNING LETTER TO RESPI FOR COMPOUNDING ACTIVITIES

The FDA has issued a warning letter to the Respi Care Group of Puerto Rico alerting the company it has committed "serious violations" of the Federal Food, Drug, and Cosmetic Act.

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DRUGMAKERS LAUNCH TOGETHER Rx CARD FOR UNINSURED

A coalition of 10 large pharmaceutical firms has launched a discount card program that could help millions of uninsured Americans save about 25 to 40 percent on commonly used prescription drugs.

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ANDRX FILES CITIZEN'S PETITION OVER AUTHORIZED GENERICS

Andrx Pharmaceuticals has filed a citizen's petition with the FDA requesting that the agency seek the advice of the FTC and the Justice Department on the contentious issue of authorized generics.

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ADDEX-ORTHO-McNEIL TIE-UP TO DEVELOP TREATMENTS FOR ANXIETY, DEPRESSION & AD

Addex Pharmaceuticals has entered an exclusive worldwide research collaboration and license agreement with Ortho-McNeil Pharmaceutical, a Johnson & Johnson company, to discover, develop and commercialize novel compounds modulating allosterically G-Protein Coupled Receptors for the treatment of anxiety, depression, schizophrenia and Alzheimer's disease.

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ALBANY MOLECULAR RESEARCH ESTABLISHES SINGAPORE RESEARCH CENTRE

Albany Molecular Research has established a wholly owned subsidiary, Albany Molecular Research Singapore Research Centre.

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PPD ACQUIRES BIOMARKER BUSINESS FROM CALIFORNIA COMPANY

PPD has struck a deal to buy the biomarker business of Menlo Park, Calif.-based SurroMed.

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ACETO MAKES FORAY INTO DRUG PRODUCTION

Specialty chemical distributor Aceto is making its first major foray into drug production, through a deal with Three Rivers Pharmaceuticals to bring three generic products to market.

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CAMBREX LICENSES POWERFUL TECHNOLOGIES FOR CONDITIONALLY IMMORTALIZED CELLS FOR USE IN DRUG DISCOVERY

Cambrex has announced that its subsidiary Cambrex Bio Science Wokingham has signed an agreement for the purchase of conditionally immortalized cell lines, related intellectual property and equipment of Xcellsyz, Newcastle Upon Tyne, UK. Cambrex Bio Science Walkersville, also a subsidiary of Cambrex, has entered into license agreements for Geron's proprietary telomerase technology and complementary conditional immortalization technology from the Ludwig Institute for Cancer Research (LICR).

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MITSUI, MEDICAL SYSTEM NETWORK TO ESTABLISH JOINT VENTURE FOR DISTRIBUTION OF ETHICAL DRUGS

Mitsui has announced that it will establish a joint venture with Medical System Network Feb. 14.

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FIELDGLASS RAISES $11 MILLION IN NEW FINANCING ROUND

Fieldglass announced today an $11 million round of funding, led by new investor Grotech Capital Group, a diversified private equity firm.

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CHEMICAL DIVERSITY, UNIVERSITY OF MARYLAND GREENEBAUM CANCER CENTER COLLABORATE ON ONCOLOGY

ChemDiv (Chemical Diversity), a leading provider of discovery chemistry services, with headquarters located in San Diego, Calif., has entered into a collaborative agreement with the University of Maryland Greenebaum Cancer Center (UMGCC) in Baltimore, Md.

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