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

• 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)