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Fdanewsdrugdailybulletin

Feb. 10, 2005

Vol. 2 No. 29

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Drugmakers Hope to Avoid Premarket Drug Safety Reforms, FDA Official Says

As lawmakers and the FDA mull over proposals to address recent drug safety concerns, pharmaceutical firms are hoping that any potential fix will not focus on the premarket side of the equation, according to a top FDA official.

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Medco Analysis Finds Pediatric Antidepressant Use Declining

Recent FDA warnings about the use of antidepressants in children appear to be having a significant effect on the number of pediatric prescriptions for the drugs, according to an analysis by one of the nation's largest pharmaceutical benefit managers.

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Oncologic Drugs Committee to Discuss Iressa

AstraZeneca's cancer treatment Iressa will be a main topic of discussion at next month's meeting of the FDA's Oncologic Drugs Advisory Committee, which will examine a recent clinical trial that raised questions about the drug's effectiveness.

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FDA to Mull the Use of Color on Product Labeling and Packaging

The FDA has issued a public call for information on the use of color on pharmaceutical labeling and packaging to determine if the practice is one that warrants further action from the agency.

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Invitrogen Signs Deal to Acquire Dynal Biotech

Invitrogen has signed a definitive agreement to acquire privately held molecular separation and purification technology pioneer Dynal Biotech from majority owner Nordic Capital and a co-investor for approximately NOK 2.5 billion.

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Albany Molecular Renews Eli Lilly Partnership

Albany Molecular Research has renewed its drug discovery research agreement with Eli Lilly.

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Maxim Cuts Jobs As Part of Realignment

Maxim Pharmaceuticals has implemented a plan realigning its resources and corporate objectives, resulting in 12 layoffs.

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Two Men Face Charges in Lipitor Conspiracy

Two men have been charged in a multimillion dollar scheme to sell counterfeit and illegally imported Lipitor. Three others have already been convicted in the plot.

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JDS and Synthon to Co-Promote Bipolar Drug

New York's JDS Pharmaceuticals and the North Carolina-based arm of Synthon Pharmaceuticals have entered into a co-promotion agreement for Lithobid, a leading brand of twice-daily lithium carbonate for the treatment of bipolar disorder.

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Wockhardt Forms JVs in Mexico, South Africa for Biopharmaceuticals

Wockhardt has set up two business joint ventures in Mexico and South Africa to enter the biopharmaceutical markets in these countries.

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Sinovac Completes Acquisition of Additional 20.56 Percent of Beijing Subsidiary

Sinovac Biotech Ltd. has announced that as of Feb. 4 it has completed the acquisition of an additional 20.56 percent of its Beijing-based operating subsidiary, Sinovac Biotech Co. Ltd. (Sinovac (Beijing)) for approximately US$3,310,000.

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Rx Processing Buys Lab Pass Associates

Rx Processing has acquired Lab Pass Associates LLC. The deal is valued at approximately $120,000.

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EpiTan In-Licenses OraDisc A From Access Pharmaceuticals

EpiTan has in-licensed the Australian and New Zealand rights to OraDisc A from Access Pharmaceuticals (Dallas, Texas) as part of its strategy to establish a specialty pharmaceutical business focused on ethical dermatology.

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