• ReconRecon

    Recon: WHO aims to buy Merck COVID drug for $10 per pill; CDC study finds Pfizer vaccine highly effective against hospitalization in 12-18 year olds

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA proposes over-the-counter hearing aids for Americans ( Reuters ) ( FDA ) Pfizer-BioNTech’s vaccine is highly effective against hospitalization for those 12 to 18, a study shows. ( NYTimes ) J&J keeps vaccine sales outlook unchanged after third-quarter miss ( Reuters ) FDA to Allow ‘Mix and Match’ Approach for Covid Booster Shots ( NYTimes ) ( Reuters ) At...
  • Regulatory NewsRegulatory News

    EC updates Clinical Trial Regulation Q&As ahead of January go-live

    The European Commission has issued an updated question-and-answer guidance clarifying certain aspects of the Clinical Trials Regulation (CTR), which is set to go into effect this January.   The revision clarifies that active pharmaceutical ingredients (APIs) used in investigational medical products do not have to comply with good manufacturing practices (GMPs) in the clinical trial application, describes the content of the protocol synopsis, and adds a new question o...
  • Regulatory NewsRegulatory News

    Cyltezo approved as interchangeable biosimilar with Humira

    An anti-inflammatory biosimilar from Boehringer-Ingelheim has received interchangeability designation from the US Food and Drug Administration (FDA).        Cyltezo (adalimumab-adbm) is now both biosimilar to and interchangeable with Abbvie’s Humira (adalimumab), announced FDA, which had granted biosimilar status to Cyltezo in 2017. Cyltezo is approved for all indications for which Humira can be used, including several inflammatory arthritides, Crohn’s disease and ulce...
  • ReconRecon

    Recon: FDA approves Oyster Point's dry eye nasal spray; EMA reviewing Pfizer vaccine in young children

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA considering lowering recommended age for Pfizer/BioNTech COVID-19 boosters ( Reuters ) FDA delays decision on Moderna's COVID-19 vaccine for adolescents ( WSJ ) ( Reuters ) FDA declines to approve Revance's frown-line treatment ( Reuters ) ( Endpoints ) Oyster Point's drug becomes first FDA-approved nasal spray to treat dry eyes ( Reuters ) ( Endpoints ) ...
  • Regulatory NewsRegulatory News

    FDA officials tout progress and achievements in advanced manufacturing

    The US Food and Drug Administration’s (FDA’S) efforts to encourage the industry’s adoption of advanced manufacturing is bearing fruit, according to a new update from the agency, noting robust interest from industry in participating in the agency’s Emerging Technologies Program (ETP).   In addition, “significant funding” from Congress has helped fund more research in advanced manufacturing, wrote Michael Kopcha, director of the Office of Pharmaceutical Quality in the FD...
  • Regulatory NewsRegulatory News

    FDA adcomm unanimous on J&J boosters for all

    The vaccines advisory committee of the US Food and Drug Administration (FDA) voted unanimously Friday to recommend a full-strength booster dose of the COVID-19 vaccine made by Janssen, the vaccines arm of Johnson & Johnson, for all recipients of the single-dose primary vaccination.   The Vaccines and Related Biologic Products advisory committee (VRBPAC) recommended that FDA issue an emergency use authorization (EUA) for a booster to be given at least 2 months after the...
  • Regulatory NewsRegulatory News

    CHMP recommends 6 medicines for authorization, Incyte pulls application for Zynyz

    The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) this week recommended six new medicines for marketing authorization in the EU.   The recommendations include positive opinions for four medicines and one generic, as well as conditional authorization for Janssen's Rybrevant (amivantamab) for the treatment of non-small cell lung cancer with activating epidermal growth factor receptor exon 20 insertion mutations.   The recomme...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. Almost two dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccine candidates that are still in development to address the lack of vaccines and access in many countries around the world; the second chart lists vaccines that are au...
  • ReconRecon

    Recon: Bayer, CureVac end vaccine production partnership; FDA calls advisory committee to discuss Merck's COVID drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers to vote on J&J vaccine booster ( Reuters ) FDA advisers back Moderna COVID booster shots for older and high-risk people ( Reuters ) ( NYTimes ) Abbott Labs unit recalling two COVID-19 lab test kits – FDA ( Reuters ) As suits mount, J&J spins out talc liabilities into Chapter 11 using 'Texas two-step' maneuver ( Endpoints ) ( FT ) FDA to Hold...
  • Regulatory NewsRegulatory News

    FDA nixes GUDID submission requirements for class I consumer healthcare devices

    Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance issued on Wednesday.   Under the agency's unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaini...
  • Regulatory NewsRegulatory News

    Unanimous thumbs up from FDA committee for Moderna booster

    An advisory committee to the US Food and Drug Administration (FDA) voted unanimously to recommend a half-strength booster dose of the mRNA COVID-19 developed by Moderna and the National Institutes of Health for those 65 years and older, and for certain younger populations at high risk of severe COVID-19.   Moderna has requested an emergency use authorization (EUA) for the 50 mcg booster dose for individuals who have already completed the two-dose series of the Moderna ...
  • Regulatory NewsRegulatory News

    IVDR: Commission proposes to delay implementation amid 'grave' notified body shortage

    Amid concerns of a market collapse and a "grave shortage" of notified body capacity, the European Commission on Thursday proposed to delay the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR).   The medical device industry has long pushed for the EU to delay IVDR, warning that the new regulation is more disruptive to the market for diagnostics than its counterpart Medical Devices Regulation (MDR), which itself was delay...