• Regulatory NewsRegulatory News

    Continuous Manufacturing: Pfizer, Vertex, AstraZeneca and Others Weigh FDA Plans

    The US Food and Drug Administration (FDA) has been encouraging the adoption of continuous manufacturing techniques for years, and several companies recently offered the agency some suggestions to refine its work around the developing technology. Background In contrast to batch manufacturing - where bulk materials are processed through multiple steps and subsequent batches must wait until the current batch is finished – continuous manufacturing allows companies to m...
  • Regulatory NewsRegulatory News

    FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug

    The US Food and Drug Administration (FDA) for the first time in its history allowed a manufacturer to switch from the more antiquated batch manufacturing process to a continuous manufacturing process – a move that FDA is seeking to encourage among more pharmaceutical manufacturers. The manufacturing change, announced last Friday, is for Janssen’s HIV-1 treatment Prezista (darunavir). And although Janssen isn’t the first manufacturer to use continuous manufacturing (Verte...
  • 'Misleading' Patient Perspective Smacked Down by FDA in Untitled Letter

    One pharmaceutical company is learning this week that reproducing a patient's story to "mentor" other potential patients may not sit well with US regulatory authorities, regardless of whether it represents the patient's perspective accurately. Cambridge, Massachusetts-based manufacturer Vertex Pharmaceuticals was sent an Untitled Letter by the US Food and Drug Administration (FDA) warning it about its promotion of Incivek (teleprevir), a Hepatitis C (HCV) drug which FD...
  • Data Reporting Mistake Hits Vertex Pharmaceuticals' Stock

    • 29 May 2012
    Hell hath no fury like a Wall Street analyst scorned. Or at least that's what Cambridge-based Vertex Pharmaceuticals might be thinking to itself today after admitting it had inadvertently overstated the effectiveness of its new combo therapy for cystic fibrosis (CF), causing shares of Vertex ( $VRTX ) to plummet. Vertex has been testing the new therapy, which consists of its already-approved drug Kalydeco (ivacaftor) and a new experimental compound known as VX 809. Unli...
  • EMA Recommends Vertex's Cystic Fibrosis Drug Kalydeco

    The European Medicines Agency (EMA) has recommended Vertex Pharmaceuticals' cystic fibrosis (CF) drug Kalydeco (ivacaftor), moving the drug one step closer to becoming the drug the first in Europe for the treatment of CF in patients with a specific gene mutation. The drug received the Committee for Medicinal Products for Human Use's (CHMP) recommendation on 25 May after being reviewed under a 150-day accelerated approval program. EMA notes Kalydeco is the eighth pro...