Recon: FDA approves first FMT drug; Pfizer plans $1.26B Dublin expansion

ReconRecon | 01 December 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA approves first fecal microbiome drug, setting stage for others (STAT) (Endpoints) (MedPage Today) (Fierce)
  • FDA pulls U.S. authorization for Eli Lilly’s COVID drug bebtelovimab (Reuters) (Endpoints)
  • Eisai, Biogen Alzheimers drug could be available to some next year (Reuters)
  • Alzheimer’s drug shows promise but needs more study for safety, researchers say (Washington Post) (Endpoints) (Reuters)
  • Eli Lilly’s Alzheimer’s drug clears more amyloid early than Aduhelm in first-ever head-to-head. Will it matter? (Endpoints)
  • US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’ (Pink Sheet)
  • Reckitt expects U.S. infant formula shortage until-spring (Reuters)
  • Persistent Lexicon still working to get an audience with FDA on Type 1 diabetes prospect (Fierce) (Endpoints)
  • CDC launches initiative to test wastewater for polioviruses in some communities (STAT) (STAT)
  • Racial disparities in lung cancer start with research (Fierce)
  • Twitter disarray continues as pharma advertisers extend pauses and look around for options, but keep tweeting (Endpoints)
In Focus: International
  • Pfizer to invest over $1.26 billion in Irish jobs boost (Reuters)
  • EU Wants Legislative Review To Support ‘World Class’ Pharmaceutical Industry (Pink Sheet)
  • Stakeholders Gather To Discuss Pandemic Response And Next Steps (Pink Sheet)
  • Britain is little better prepared for future pandemics - Former UK vaccine chief (Reuters)
  • Canada Consults On Real World Evidence Guidance For HTAs And Regulators (Pink Sheet)
  • Industry Calls For Canadian Pricing Guideline Consultation To Be Suspended (Pink Sheet)
  • Pakistan Proposes Risk-Based Inspections Approach ‘Capable Of Revealing Weaknesses’ (Pink Sheet)
Pharma & Biotech
  • Catalent to cut about 600 jobs in Indiana, Maryland and Texas (Endpoints)
  • Roche shutters most trials of Alzheimer’s drug after failed trials (Reuters) (STAT)
  • SQZ Biotech slashes headcount by 60% as founder/CEO hits exit — while Synlogic lays off 25% (Endpoints)
  • Horizon Therapeutics in takeover talks with Amgen, J&J, Sanofi as potential buyers (Endpoints)
  • Sana, Codexis lay off staff, reshuffle pipeline in bid to focus cell therapy, enzyme engineering work (Endpoints)
  • With early data and a possible advantage, Amgen enters the obesity drug race (STAT)
  • Pfizer, Roivant team up for new inflammatory-focused Vant-and no, they’re not calling it Pfant (Fierce)
  • Pfizer-Valneva’s Lyme vaccine triggers 6-month antibody response, validating phase 3 regimen (Fierce)
  • Fresh off layoffs, X4 scores a phase 3 win for immune deficiency disorder drug (Fierce)
  • J&J unit, happy with AC Immune Alzheimer’s work, moves 1 of 2 shots to next step (Fierce)
  • Sanofi’s sleeping sickness drug cures 95% of people in phase 2/3 trial, boosting plan to stop transmission (Fierce)
  • Argenx purchases $100M+ FDA priority review voucher from bluebird bio (Endpoints)
  • Rallybio, AbCellera form new partnership around antibodies for rare disease (Endpoints)
  • CPI opens the doors to a new $100M+ manufacturing facility in Scotland (Endpoints)
Medtech Government, Regulatory & Legal
  • Protecting its megablockbuster, Janssen challenges Amgen's Stelara biosimilar ahead of planned 2023 launch (Endpoints) (Reuters)
  • Merck sues Johns Hopkins for licensing Keytruda patents in secret and in conflict with research collaboration (Endpoints)
  • Gilead Sciences Prevails in HIV Drug Patent Suit Against CDC (Bloomberg)
  • Bausch’s Patents on Duobrii, Bryhali Psoriasis Drugs Are Upheld (Bloomberg)
  • U.S. urges 15-year sentence for ex-Theranos president Balwani (Reuters)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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