• This Week at FDAThis Week at FDA

    This Week at FDA: User fee timeline, bivalent boosters, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the agency’s decision to recommend the inclusion of an Omicron BA.4/5 component in future booster doses in the first shift in strain composition away from monovalent vaccines targeting the prototype virus.   Alongside the recommendation, FD...
  • Regulatory NewsRegulatory News

    FDA calls for inclusion of Omicron BA.4/5 in future boosters

    Heeding the advice of its expert advisory committee, the US Food and Drug Administration (FDA) on Thursday recommended the inclusion of an Omicron BA.4/5 spike protein component in modified COVID-19 vaccine boosters for the upcoming fall and winter seasons.   The recommendation follows a 19-2 vote in favor of adding an Omicron-specific component to future boosters by FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) earlier this week. (RELATED:...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Spring regulatory agenda, upcoming guidances, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we get a glimpse at FDA’s Spring regulatory agenda and get tips on several upcoming guidances. Plus, we learn about a new 510(k) pilot program for CBER-regulated medical devices.   Next week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will ...
  • Regulatory NewsRegulatory News

    FDA explains when it will rescind breakthrough designations

    The US Food and Drug Administration (FDA) on Thursday released draft guidance explaining its thought process for rescinding breakthrough therapy designation (BTD) during its evaluation of a drug.   While FDA has long asserted its authority to rescind or withdraw BTDs, the new guidance will add clarity for sponsors as to when the agency might revoke the designation. Since designation was created under the Food and Drug Administration Safety and Innovation Act in 2012,...
  • ReconRecon

    Recon: EMA recommends Valneva COVID vaccine; Novartis wins FDA approval for Tafinlar + Mekinist combo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen, citing insurance challenges, shutters one of its Aduhelm studies ( BioPharmaDive ) U.S. FDA labels Baxter's respiratory device recall as most serious ( Reuters ) Novartis wins U.S. approval for targeted cancer drug combination ( Reuters ) Despite fanfare, the FDA’s step toward lowering nicotine levels in cigarettes is a very early one ( STAT ) U.S. FD...
  • ReconRecon

    Recon: Moderna touts bivalent booster’s response against Omicron subvariants; EU to raise investment in Latin American drug manufacturing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna booster candidate shows strong response against Omicron subvariants ( Reuters ) Moderna CEO: COVID variant vaccine to be ready for shipping in August ( Reuters ) Omicron-specific COVID vaccines on the horizon, Pfizer chief says ( Reuters ) More vulnerable people receiving fewer COVID pills - U.S. study ( Reuters ) FDA to Order Juul E-Cigarettes Off U....
  • ReconRecon

    Recon: Novartis loses patent appeal for MS drug Gilenya; European Commission investigates Vifor for anticompetitive practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 'Put up or shut up': Biden, Dems have one last chance to resurrect drug pricing reforms ahead of elections ( Endpoints ) Medicare could have saved billions on drugs if it paid what Mark Cuban charges at his new pharmacy ( STAT ) ( Endpoints ) Merck touts new data for breakthrough pneumococcal vaccine as it heads to PhIII trials ( Endpoints ) U.S. Supreme Court...
  • ReconRecon

    Recon: Pfizer to buy 8.1% stake in Valneva, Merck explores Seagen buyout

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID vaccine rollout for US children close after CDC panel vote ( Reuters ) Lawmakers ask GAO to probe pharmacy benefit managers over their role in drug pricing ( STAT ) Comparing the Pfizer and Moderna Covid vaccines for young children ( STAT ) Merck Explores Purchase of Biotech Seagen ( WSJ ) FDA advisors mostly agree that Acadia’s Nuplazid isn't effective...
  • ReconRecon

    Recon: Moderna to study COVID vaccine in babies 3 to 6 months of age; Walgreens enters clinical trial business

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Commissioner Admonishes Health Care Stakeholders To Know Agency Better, Help More ( MedtechInsight ) Moderna to Study Its Covid-19 Vaccine in Babies as Young as 3 Months ( WSJ ) FDA Panel Recommends Pfizer and Moderna Vaccines for Youngest Children ( NYTimes ) ( STAT ) Abbott Baby Formula Plant Again Stops Production, This Time Because of Flooding ( NYT...
  • ReconRecon

    Recon: EMA starts rolling review of Pfizer-BioNTech variant vaccine; Pfizer halts Paxlovid study enrollment for lower-risk population

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Advisers Review Pfizer, Moderna Covid-19 Vaccines in Young Children ( WSJ ) ( STAT ) ( Reuters ) US pivots to ‘harm reduction’ after 107,000 overdose deaths last year ( FT ) Briefing docs for Acadia's Alzheimer's-related psychosis resubmission reveal an undecided FDA ( Endpoints ) Bristol Myers asks Supreme Court to revive $1.2 bln cancer-drug patent win (...
  • ReconRecon

    Recon: FDA approves Lilly’s alopecia drug; EU states pressure Pfizer to cut unneeded COVID vaccine supplies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA advisers weigh Moderna COVID vaccine heart risk for young men ( Reuters ) FDA Advisers Considering Moderna’s Covid-19 Vaccine for Ages 6 to 17 ( WSJ ) Alnylam wins FDA approval of rare disease drug in step toward profitability ( BioPharmaDive ) Amylyx's ALS drug would be more cost effective if priced around $170,000, pricing watchdog says ( Reuters ) ...
  • ReconRecon

    Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...