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  • ReconRecon

    Recon: Pfizer says COVID vaccine is 90.7% effective in children 5-11; Oncopeptides pulls Pepaxto after failing confirmatory trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Walgreens U.S. stores start administering Moderna, J&J COVID-19 booster ( Reuters ) Americans can mix and match COVID-19 boosters but original vaccine recommended -Fauci ( Reuters ) C.D.C. Recommends Covid Booster Shots for Millions of Americans ( NYTimes ) ( STAT ) Pfizer/BioNTech COVID-19 vaccine shows 90.7% efficacy in trial in children ( Reuters ) Oncopep...
  • Regulatory NewsRegulatory News

    FDA withdraws more than 200 ANDAs over unsubmitted annual reports

    Almost two years after proposing to withdraw nearly 250 abbreviated new drug applications (ANDAs) after their manufacturers repeatedly failed to submit the necessary annual reports, the US Food and Drug Administration (FDA) on Thursday said it will withdraw 216 of those applications.   The withdrawals follow a notice of opportunity for hearing (NOOH) FDA published in January 2020 that listed 249 applications from 89 drugmakers with delinquent annual reports. (RELATED: ...
  • ReconRecon

    Recon: CDC panel meets on Moderna, J&J boosters, 'mix and match'; FDA issues refuse-to-file letter for Stealth's Barth syndrome drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA authorizes Moderna, J&J Covid-19 boosters, allows mix-and-match shots ( Politico ) ( Reuters ) ( FDA ) A C.D.C. panel is meeting for debate on boosters and the ‘mix-and-match’ strategy. ( NYTimes ) A 30-Year Campaign to Control Drug Prices Faces Yet Another Failure ( NYTimes ) Pfizer, in a first, shows booster shot strengthens COVID-19 protection in large ...
  • ReconRecon

    Recon: Novavax falls on reports of production delays; Biogen's Aduhelm sales fall well below expectations

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US ‘They rushed the process’: Vaccine maker Novavax's woes hamper global inoculation campaign ( Politico ) ( Reuters ) Novavax expresses fresh confidence in its vaccine ( Politico ) Biogen banks on government coverage to restart stalled Alzheimer's drug sales ( Reuters ) Biogen’s Aduhelm sales fall dramatically below Wall Street’s expectations ( STAT ) Cigna's p...
  • 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...
  • 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

    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...
  • 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

    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...
  • ReconRecon

    Recon: White House reportedly eyeing Califf as FDA commissioner; EU kicks off review of AstraZeneca COVID antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House zeroes in on Califf to head FDA as deadline nears ( Washington Post ) U.S. FDA advisers weigh case for COVID-19 vaccine booster shots ( Reuters ) ( STAT ) J&J COVID-19 shot gets better boost from Moderna or Pfizer in NIH study ( Reuters ) ( NBC ) Data from Federal Scientists Raise Questions About J.&J. Booster Shots ( NYTimes ) Biden official warn...
  • ReconRecon

    Recon: FDA approves Lilly's Verzenio for early breast cancer; Ebola vaccination campaign begins in Congo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Data suggests mRNA booster dose generates stronger antibody response after J&J shot – Axios ( Reuters ) Relying on J&J's analyses to assess vaccine booster dose data -U.S. FDA staff ( Reuters ) ( NYTimes ) US FDA staff says Moderna did not meet all criteria for COVID-19 boosters ( Reuters ) Vaccine requirements raised COVID-19 vaccination rates by 20 percentag...
  • ReconRecon

    Recon: Merck seeks US authorization for COVID drug; EMA reviewing Regeneron, Roche COVID antibody

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck seeks first U.S. authorization for COVID-19 pill ( Reuters ) Roche says Alzheimer's therapy gets U.S. breakthrough designation ( Reuters ) U.S. CDC advisers to review Moderna, J&J COVID-19 booster shots this month ( Reuters ) Govt to control distribution of GSK/Vir COVID-19 antibody in U.S. – FDA ( Reuters ) Adamas, Flexion sell for $825M combined as de...