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March 7, 2005

Vol. 2 No. 46

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GAMP Forum Issues Guide on Electronic Records and Signatures

The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), has released its "GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures."

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FDA Should Act on Follow-On Biologics, Waxman Says

Although Rep. Henry Waxman (D-Calif.) continues to support the Hatch-Waxman Act, he acknowledged recently that the law is not a complete solution to the problems generic drugmakers face in trying to bring new products to market, particularly generic biologic products.

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Lawmaker Urges SEC to Assess Requirements for Postmarketing Studies

A top Democratic representative is prodding the SEC to take a harder look at how pharmaceutical companies disclose information about postmarketing studies to shareholders.

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Big Pharma Could Get Boost From Promising New Drugs in 2005, S&P Says

Although the pharmaceutical industry has been criticized in recent years for its lack of productivity on the R&D front, there are a number of promising products -- either newly approved or soon-to-be-approved -- that could give big pharma firms a boost in 2005 and beyond, according to a new research report from Standard & Poor's (S&P).

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Corixa and Lorantis Announce Joint Collaboration to Develop Vaccine

Corixa, a developer of immunotherapeutics, and Lorantis, a Cambridge, UK-based immunotherapy company, have announced a joint collaboration in which the companies will continue the development of a therapeutic hepatitis B vaccine, containing Corixa's RC-529 adjuvant and Lorantis' CV-1831, a hepatitis B core antigen that was previously owned by Apovia.

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Allos Nabs $50 Million From Warburg Pincus

Publicly traded drugmaker Allos Therapeutics announced Thursday, March 3, it secured $50 million in private equity from Warburg Pincus to help bring its lead cancer medicine to market.

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Flamel Terminates Biovail License Pact

French biopharmaceutical firm Flamel Technologies SA said it terminated the company's license agreement with Biovail Laboratories Inc. for Genvir, Flamel's oral controlled-release form of acyclovir for the treatment of genital herpes.

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Interleukin Genetics Extends With Alticor

Interleukin Genetics has signed two new research agreements with Access Business Group, a subsidiary of Alticor. The company also reported that it has modified its stock purchase and distribution agreements with other affiliates of Alticor.

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PDI Announces Details of Its 2005 Agreements With AstraZeneca

PDI has announced the details of its 2005 agreements with AstraZeneca.

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Cubist to Purchase 2 Percent Reduction in Cubicin Royalty Rate From Lilly

Cubist Pharmaceuticals entered into definitive agreements to purchase from Eli Lilly and company a 2 percent reduction in the royalties payable to Lilly on net sales of Cubicin (daptomycin for injection).

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Taro to Divest ElixSure and Kerasal OTC Products to Alterna

Taro Pharmaceutical Industries and its subsidiaries reported that the company has entered into multiyear agreements to divest its OTC ElixSure and Kerasal products in North America to Alterna.

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Biovail Says SEC Probe Is Now Formal

Biovail has reported that the Securities and Exchange Commission has launched a formal investigation into the Toronto-based drug maker's accounting practices.

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