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Domestic and foreign FDA inspections of biologic and drug manufacturing facilities declined in fiscal 2006, from 4,513 in 2005 to 4,237, according to a recent report from the FDA's Office of Regulatory Affairs.
Glenmark, a wholly owned Swiss subsidiary of India-based Glenmark Pharmaceuticals, has agreed to acquire a majority share of the Czech firm Medicamenta.
The U.S. FDA has granted tentative approval to a generic formulation of the HIV drug efavirenz manufactured by Strides Acrolab under the expedited-review provisions created for the President's Emergency Plan for AIDS Relief (PEPFAR).
As part of a legal settlement, Novartis will assist Bayer Schering
Pharma in obtaining U.S. FDA validation of Bayer's outsourced European Betaseron manufacturing facility, Bayer said this week.
French drugmaker sanofi-aventis and UK-based Oxford BioMedica have entered into an exclusive global license agreement to develop and commercialize TroVax for the treatment and prevention of cancer.
Indonesia will immediately resume supplying the World Health
Organization (WHO) with viruses from its bird flu outbreak, a vital tool in producing vaccines, while the agency will seek to ensure access to commercially developed flu vaccines, WHO has announced.
Despite public commitments by governments and international organizations to tackle the so-called dual epidemic of tuberculosis (TB) and HIV, there is little evidence of progress, according to Médecins Sans Frontières (MSF).
The Public Patent Foundation (PUBPAT) announced it has filed formal requests with the U.S. Patent and Trademark Office challenging four key HIV drug patents held by Gilead Sciences.