• RoundupsRoundups

    Euro Roundup: Generic manufacturers ask EU for inflation help

    Leaders at generic drug manufacturers including Sandoz, Teva and Viatris have written to European Union authorities to request actions that enable them to cope with “rampant cost inflation.”   In a letter published by the trade group Medicines for Europe, generic drug manufacturers make the case that the combination of inflation and “policies that continuously lower prices” is unsustainable. Inflation in Europe is above 7% for the first time in decades and the generic ...
  • 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...
  • Regulatory NewsRegulatory News

    Official encourages ATMP sponsors to consult toolbox guidance to avoid PRIME derailments

    An EU official advised manufacturers of advanced therapy medicinal products (ATMPs) to consult the European Medicines Agency’s (EMA) recently issued “toolbox” guidance to avoid having products rejected from being eligible for accelerated review under the PRIME program for quality-related deficiencies.   Barbara Bonamassa, a reviewer with the Italian Medicines Agency (AIFA), offered an update on some of the EU’s ongoing activities to expedite the development of ATMP the...
  • 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...
  • Regulatory NewsRegulatory News

    House subcommittee moves FDA $3.6B budget forward

    Lawmakers in the House Appropriations agriculture subcommittee have sent their FY 2023 budget package that includes funding for the US Food and Drug Administration (FDA) to the full committee, proposing $3.6 billion in discretionary funding for the agency to address the opioid crisis, further research on amyotrophic lateral sclerosis (ALS), foreign inspections and more.   On 15 June the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies ...
  • Regulatory NewsRegulatory News

    Clinical trial diversity: Sponsors seek clarity on data sources, timing

    Drugmakers and clinician organizations praised the US Food and Drug Administration’s (FDA) recent draft guidance containing recommendations on developing a Race and Ethnicity Diversity Plan to improve enrollment of underrepresented racial and ethnic groups in clinical trials. But in public comments, they also called for greater details on the types of data that should be used to assess adequate enrollment of these populations, how these diversity plans should be applied to...
  • Regulatory NewsRegulatory News

    Former FDA officials call for more transparency for drug approvals

    The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...
  • 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 (...
  • Regulatory NewsRegulatory News

    Senate HELP sends user fee reauthorization bill to floor vote

    The US Senate Health, Energy, Labor and Pensions (HELP) committee advanced a bill that would reauthorize the Food and Drug Administration (FDA) to collect medical product user fees. It differs significantly from a sister bill recently passed in the House, meaning it would need to be reconciled in a conference if it is approved by the full Senate.   In a 13 to 9 vote, the HELP committee approved the Food and Drug Administration Safety and Landmark Advancements (FDASL...
  • Regulatory NewsRegulatory News

    VRBPAC unanimously backs Moderna vaccine for children 6 and up

    The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend Moderna’s COVID-19 vaccine as a two-dose series for emergency use authorization (EUA) in children 6 years and older.   The committee met on Tuesday to discuss Moderna’s COVID-19 vaccine EUA request to include children and adolescents 6 years through 17 years of age. Moderna sought an EUA for a two-dose primary series for adoles...
  • 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 ) ...
  • RoundupsRoundups

    Asia-Pacific Roundup: PMDA outlines changes to project focused on medicine use in pregnancy

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has shared details of changes to a system for promoting the proper use of drugs for pregnant and breastfeeding women. The system went live last month to support the creation of a registry and the digitization of applications.   Officials created the Japan Drug Information Institute in Pregnancy (JDIIP) in 2005 to collect and review the latest evidence on the effects of medicines on mothers and fetuses. Using the...