We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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.
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.
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).
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.
Drugmaker Bradley Pharmaceuticals Inc. reported Monday that the Securities and
Exchange Commission launched an informal probe to determine if the company violated
securities laws.
Integrated systems biology company Icoria has licensed to Syngenta the exclusive
rights to commercially develop 30 Icoria compounds believed to be active fungal
inhibitors.
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.