FDAnews Drug Daily Bulletin
April 4, 2005 | Vol. 2 No. 66
Acting FDA Commissioner Lester Crawford is keeping the pressure on firms' direct-to-consumer (DTC) advertising practices, as some pharmaceutical companies already are moving to ensure their ads are more informative and balanced.
The FDA's premarketing and postmarketing safety programs from drugs and biologics will be at the top of the agenda when the agency's Science Board convenes this month.
Investigators, sponsors and institutional review boards (IRBs) looking to reduce the time it takes to conduct multicenter clinical research should consider implementing a centralized IRB review process, suggests a new FDA draft guidance that describes how to initiate the review strategy.
Teva Pharmaceutical has received tentative approval from the FDA to launch generic versions of two blockbuster drugs -- Eli Lilly's antidepressant Zyprexa and Pfizer's blood pressure medication Norvasc.
Halozyme Therapeutics, a development stage biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation announced that they have expanded their relationship by signing a development and supply agreement for Enhanze SC, Halozyme's recombinant human hyaluronidase enzyme (rHuPH20).
Invitrogen Corporation announced that it has completed its acquisition of Dynal Biotech. Invitrogen acquired Dynal from majority owner Nordic Capital and a co-investor in a cash transaction totaling approximately 2.5 billion NOK, or approximately $391 million, based on foreign currency forward contracts executed previously by Invitrogen.
Impax Laboratories Inc. said it did not file its annual 10-K financial report with the Securities and Exchange Commission by March 31, the end of a 15-day extension granted by the SEC.
Vertex Pharmaceuticals Inc. plans to raise up to $200 million in the coming months to help fuel research and development, clinical trials and potential acquisitions.
Progenics Pharmaceuticals, Inc. announced the pricing of an underwritten public offering of 2 million shares of its common stock pursuant to an effective shelf registration statement.
Bayer said Friday that it has completed the previously announced $590 million sale of its plasma products business to Talecris Biotherapeutics Inc.
New research from Health Direction, the healthcare business intelligence specialists, has today revealed that over half (52 percent) of (UK) NHS professionals surveyed believe that integration and communication between different areas of the NHS is the most important factor affecting their ability to carry out their role.
PPD Inc. has relocated its Phase I clinic and Phase I-III central lab in Austin, Texas, to a larger facility.
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