Recon: FDA approves first FMT drug; Pfizer plans $1.26B Dublin expansion
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)
- 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)
- 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)
- EU Regulation Is Driving Medical Device Manufacturers from EU Market (Quality Digest) (MedTech Insight) (MedTech Dive)
- More Than 50% Of EU Clinicians Report Recent Medical Device Shortages (MedTech Insight)
- Temporary Stent To Treat Prostate Enlargement Gets FDA Greenlight (MedTech Insight)
- CMR Signs Deal With J&J To Bring Robots To Europe And South America (MedTech Insight)
- Boston Scientific snatches up gastro-focused Apollo Endosurgery for $615M (Fierce) (MedTech Insight)
- Titan Medical eyeing possible sale, merger amid threat of Nasdaq delisting (Fierce)
- 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)
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