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Fdanewsdrugdailybulletin

March 1, 2005

Vol. 2 No. 42

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Cox-2 Drug Class Gets Restrictions From EMEA

The European Medicines Agency (EMEA) has become the first regulatory body to impose sweeping restrictions on Cox-2 inhibitor drugs, announcing recently that it will require labeling changes and physician warnings for the controversial drug class.

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Teva, GlaxoSmithKline Settle Patent Litigation Over Lamictal

Teva Pharmaceutical has settled patent litigation with GlaxoSmithKline (GSK) that will enable it to market a generic version of GSK's Lamictal.

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FDA Official Recommends Firms Consult FDA Prior to eCTD Submissions

Drugmakers should consult with the FDA before drafting their first electronic common technical document (eCTD) submission to ensure the documentation is prepared properly and conforms to agency requirements, advises a Center for Drug Evaluation and Research (CDER) official.

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FDA Releases Guidance on NDA, BLA Safety Reviews

The FDA has announced the availability of final guidance for industry on how to conduct a safety review of a new drug application (NDA) and a biologics license application (BLA).

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Genzyme Expands Asia-Pacific Regional Operation in HK

Genzyme, a biotechnology company, has announced the expansion of its Asia-Pacific regional office in Hong Kong.

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Impax Files Motion to Intervene as Defendant in Suit Related to Generic Allegra-D

Impax Laboratories Inc. has filed a motion in the U.S. District Court for the District of Columbia to intervene as a defendant in a lawsuit by Barr Laboratories, Inc. against the FDA. Earlier this month, Barr Laboratories, a subsidiary of Barr Pharmaceuticals Inc. brought suit against the FDA in an attempt to prevent the agency from granting final approval to Impax's abbreviated new drug application (ANDA) for its fexofenadine HCl and pseudoephedrine HCl extended-release tablets, a generic version of Allegra-D.

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Esoterix Price May Hit $240 Million

One of Austin's brightest bioscience companies, Esoterix Inc., reportedly is for sale and could fetch as much as $240 million.

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Valera Pharmaceuticals Out-Licenses to Rights to Vantas

Valera Pharmaceuticals has entered into an agreement with BioPro Pharmaceutical (USA), based in San Francisco, Calif.

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Bradley Subject of Informal SEC Probe

Drugmaker Bradley Pharmaceuticals Inc. reported Monday that the Securities and Exchange Commission launched an informal probe to determine if the company violated securities laws.

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Icoria Signs Licensing Agreement With Syngenta

Integrated systems biology company Icoria has licensed to Syngenta the exclusive rights to commercially develop 30 Icoria compounds believed to be active fungal inhibitors.

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Evotec Enters Into Medicinal Chemistry Agreement With Mitsubishi

Evotec OAI AG, a leading partner for integrated high-value-added drug discovery and development solutions to the pharmaceutical and biotechnology industries, has announced that it will support Mitsubishi Pharma, Osaka, Japan, in its medicinal chemistry programs.

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