• Regulatory NewsRegulatory News

    VRBPAC recommends addition of Omicron-component to future boosters

    A panel of experts recommended the inclusion of an Omicron component in future COVID-19 vaccine boosters in the United States. Public health officials suspect another surge in COVID-19 cases this fall and are considering boosters with an updated strain composition in hopes that vaccine targeting a more recent strain of the virus will be more effective.   FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 28 June to discuss whether the a...
  • ReconRecon

    Recon: FDA signals support for updated COVID vaccines; EMA recommends BioMarin’s hemophilia gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel to advise on whether — and how — Covid vaccines should be updated ( STAT ) ( NYTimes ) ( Endpoints ) ( Fierce ) Pfizer/BioNTech say Omicron-based COVID shots improve response vs that variant ( Reuters ) FDA places partial clinical hold on David Hung biotech after certain cancer patients experience eye inflammation ( Endpoints ) Astellas’ gene therapy...
  • 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: 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...
  • Regulatory NewsRegulatory News

    FDA authorizes Pfizer, Moderna vaccines for youngest children

    The US Food and Drug Administration (FDA) on Friday authorized the emergency use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children as young as 6 months of age, asserting that the benefits of the vaccines outweigh the risks.   This action comes two days after the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to support expanding the emergency use authorizations (EUAs). (RELATED: VRPAC recommends Pfizer, Mode...
  • Regulatory NewsRegulatory News

    VRBPAC recommends Pfizer, Moderna COVID vaccines for youngest children

    On Wednesday, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of amending FDA’s emergency use authorization (EUA) for Moderna’s two-dose vaccine to include children 6 months through 5 years of age. The committee voted separately in favor of recommending to amend Pfizer’s EUA for its vaccine and authorize use of a three-dose vaccine for children 6 months through 4 years of age.   In a 21-0 v...
  • 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 )...
  • Regulatory NewsRegulatory News

    FDA authorizes second round of mRNA boosters for older and immunocompromised people

    The US Food and Drug Administration (FDA) on Tuesday signed off on a second round of COVID-19 vaccine booster shots for immunocompromised individuals and people 50 years of age and older.   The agency said the boosters can be administered four months after receiving the first booster dose of any authorized or approved COVID-19 vaccine in both populations.   The populations covered by the latest authorizations differ from those sought by the two vaccine makers. Pfiz...
  • This Week at FDAThis Week at FDA

    This Week at FDA: MDUFA’s turn in Congress, another COVID vaccine adcomm, 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 learn that the House Energy and Commerce committee will finally take up legislation to reauthorize the Medical Device User Fee Amendments (MDUFA) next Wednesday. Plus, we look at upcoming developments on COVID-19 vaccines and a much-anticipated advisory committee meeting o...
  • Regulatory NewsRegulatory News

    FDA panel split on approach to COVID-19 vaccines for younger children

    Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.   Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as th...