• AstraZeneca Sues FDA to Halt Generic Seroquel

    Pharmaceutical manufacturer AstraZeneca filed a lawsuit on 13 March seeking an injunction against the US Food and Drug Administration (FDA) to bar it from allowing generic versions of its blockbuster antipsychotic drug Seroquel to be marketed in the US. FDA denied two Citizen Petitions from AstraZeneca on 9 March that requested FDA delay market entry for any generic products not containing the exact warnings contained on the reference listed drug (RLD). FDA said in its...
  • In Landmark Ruling, Indian Generics Manufacturer Obtains Compulsory License

    In a landmark ruling, the Indian Patent Office (IPO) has granted generics manufacturer Natco a compulsory license to manufacture Bayer's oncology drug Nexavar, reports Pharmalot . The 9 March ruling has the could revolutionize the pharmaceutical industry in India by potentially allowing any number of generic manufacturers to challenge patented medicines so long as they pay royalties to the original manufacturer and seek to lower the price of the drug in order to make it...
  • India's Pharmaceutical Industry Prepare for Pivotal Court Hearing on Drug Patents

    The Indian Supreme Court is set to hear a pivotal challenge to its patent system by Swiss pharmaceutical manufacturer Novartis, which is seeking to force the Indian government to recognize its patent on cancer drug Gleevec, reports the New York Times . Novartis contends that India improperly denied its patent for Gleevec-and, by proxy, those of many other drugs manufactured by western pharmaceutical companies-and filed suit six years ago to challenge the patent's status...
  • ULTRA Bill Introduced in the House Legislation Seeks to Permit Broader Use of Scientific Data to Support Surrogate Endpoints for 'Ultra Orphan' Drug Approvals

    • 03 January 2012
    Two congressmen have introduced legislation that would amend the Food, Drug and Cosmetic Act to provide an easier, accelerated approval pathway for drugs for "Ultra Orphan" diseases, which affect fewer than 6,000 people.  In comparison, "Orphan Diseases" affect fewer than 200,000 individuals. The bill, Unlocking Lifesaving Treatments for Rare-Diseases Act (ULTRA) (H.R. 3737), would allow for surrogate endpoints that is "reasonably likely, based on epidemiologic,...