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Jan. 24, 2005

Vol. 2 No. 16

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COMBINATION PRODUCTS REPORT FOCUS OF RAPS SUMMIT

The Combination Products Coalition (CPC) intends to submit a draft report to the FDA with recommendations on how FDA intercenter agreements can be modified to better define roles and responsibilities for handling approvals, modifications and preapproval inspections for combination products.

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FDA CITES PFIZER FOR FALSE, MISLEADING ADS

The controversy surrounding Pfizer's Cox-2 inhibitors, Celebrex and Bextra, took a new turn when the company was cited by the FDA for making false and misleading statements in advertisements for the painkillers.

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HHS TASK FORCE CALLS FOR IMPROVED COOPERATION

To help speed the availability of innovative medical products, HHS should create a forum that will enable investigators and developers to discuss their products with key research, regulatory and reimbursement agencies, according to an HHS task force report.

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SOLVAY PHARMACEUTICALS COMPLETES ACQUISITION OF NEOPHARMA IN SWEDEN

Solvay Pharmaceuticals has announced the successful completion of the acquisition of Neopharma AB, a company based in Uppsala, Sweden, as shareholders representing 100 percent of the company's capital accepted the friendly takeover bid launched by Solvay last December.

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BOLDER BIOTECHNOLOGY AWARDED NIH GRANT TO DEVELOP NOVEL ARTHRITIS TREATMENT

Bolder BioTechnology has been awarded a $100,000 Phase I Small Business Innovation Research (SBIR) grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of NIH.

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SCHERING TO BUY NEOGENESIS

Seeking to improve its drug discovery technology and establish a beachhead in the fertile Cambridge biotechnology cluster, drug giant Schering-Plough of Kenilworth, N.J., said it would buy NeoGenesis Pharmaceuticals of Cambridge for an undisclosed sum.

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COLLAGENEX MOVING TO PROTECT PATENT

CollaGenex Pharmaceuticals has said it intends to seek "prompt injunctive relief" to protect its patent and intellectual property rights following a decision by the U.S. District Court for the District of Columbia.

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CARDINAL HEALTH, EISAI SIGN MULTIYEAR DISTRIBUTION SERVICE AGREEMENT

Cardinal Health, the leading provider of products and services supporting the healthcare industry, has reached agreement with Eisai to provide distribution services for Eisai's life-enhancing therapies.

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CIPHER PHARMACEUTICALS SELLS PHARMA MEDICA RESEARCH TO MANAGERS FOR $19 MILLION

Cipher Pharmaceuticals will sell its Pharma Medica Research division to the current management team of Pharma Medica for $19.1 million, the company said.

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WOCKHARDT TO MANUFACTURE ARICEPT FOR EISAI PHARMACEUTICALS

The Mumbai-based Eisai Pharmaceuticals India has identified Wockhardt as the company's partner for the manufacture of its Alzheimer's drug Aricept (donepezil hydrochloride tablets) in India.

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AKESIS PHARMACEUTICALS ANNOUNCES COMPLETION OF ACQUISITION

Akesis Pharmaceuticals (formerly known as Liberty Mint) has completed the acquisition of Akesis Pharmaceuticals (Delaware) and named key employees and directors of the post merger company.

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NOVARTIS SUCKED INTO SFO INQUIRY

The Serious Fraud Office is investigating a division of Novartis, one of the world's largest pharmaceutical firms, for alleged criminal marketing practices as part of its investigation into alleged price-fixing by drugs companies.

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