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  • Regulatory NewsRegulatory News

    Pfizer Wins Indian Patent on Prevnar 13 Vaccine

    India's patent office has granted Pfizer a patent on its pneumococcal conjugate vaccine (PCV), known as Prevnar 13, after Doctors Without Borders (MSF) challenged the patent’s claims. The decision follows a campaign from MSF that began in March 2016 to allow for more affordable versions of the vaccine to come to market in India. In October 2016, MSF rejected a Pfizer offer to donate a significant number of PCV doses. "By giving the pneumonia vaccine away for fre...
  • FDA Issues New Draft Guidance on Bacterial Pneumonia Treatments

    A new draft guidance document issued by the US Food and Drug Administration (FDA) is intended to provide clearer expectations for developers of therapies to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). The guidance, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment , replaces an earlier 2010 guidance by the same name in the hopes of providing additional and updated ...
  • Regulators Refine Recommended Approach to Developing Drugs to Treat Pneumonia

    A new draft guidance document issued by US regulators looks to expedite and facilitate the clinical development of drug therapies intended to treat community-acquired bacterial pneumonia (CABP). FDA had last issued a guidance on CABP in 2009, but said feedback prompted it to make significant changes to "attain a greater degree of balance between the practicability of conducting CABP clinical trials and the trial procedures needed for a scientifically sound and interpreta...
  • FDA Close to Approving J&J Drug Via Animal Rule Pathway

    Advisers from the US Food and Drug Administration (FDA) are backing a Levaquin, a drug candidate manufactured by Johnson & Johnson, despite the drug not undergoing human clinical trials, reports Fierce Pharma . The backing would involve the extremely rare use of an approval pathway known as the 'Animal Rule' pathway, which was created after a series of anthrax-based terror attacks in 2001 prompted FDA and other governmental officials to seek an approval pathway for ...