Recon: Biogen to pay $900M to resolve physician kickback claims; FDA places partial hold on Avidity’s muscle disorder drug

• Completely clean FDA-industry user fee deal attached to a must-pass government spending bill (Endpoints) (Bloomberg) (STAT)
• Biogen finalizes $900M drug kickback settlement, U.S. says (Reuters) (Endpoints) (Fierce) (Law360)
• FDA slaps a partial hold on Avidity's mAb-siRNA therapy, pausing enrollment in muscle weakness disease study (Endpoints) (Fierce) (Reuters)
• Vertex, CRISPR to Submit Exa-Cel to FDA for Sickle Cell and Beta Thalassemia (Biospace) (BiopharmaDive)
• Research Protection Rules Standardized Under FDA Proposals (Bloomberg)
• Overworked and ready for expansion: FDA's cell and gene therapy office preps to add about 100 new positions (Endpoints)
• Even as pandemic recedes, short-staffed trial sites leave cancer patients waiting (Endpoints)
• 'Incorrect' To Assume Interchangeables Are Safer, More Effective Than Biosimilars, Says FDA (Pink Sheet)
• U.S. FDA Flags Quality, Procedural Lapses At Biocon Biologics’ Facilities (BQ Prime)
• FDA Allowed Release Of Moderna COVID Booster While Still Mulling Plant Inspection Findings (Pink Sheet)
• New drug price law could help Part D enrollees who can't fill cancer treatments due to costs, White House says (Endpoints)
• New study sees possible link between aluminum in childhood vaccines and risk of asthma, but caveats abound (STAT)
• New book recounts the FDA’s ‘unholy birth’ (Washington Post)

• EU Seeing Success in Trial Transparency, but Some Member Nations Holding Back (FDAnews)
• Pharma Disappointed By New Extension Of EU Signal Detection Pilot (Pink Sheet)
• Cell, Gene Therapy A No Entry Zone? EU Group Seeks Clarification Over China Regs (Pink Sheet)
• Europe's generic drugmakers may cut output due to surging energy bills (Reuters)
• Amid conspiracy and conflict, WHO’s Tedros plans for the next pandemic (Washington Post)
• Economic Crisis Expected To Shape UK’s Future Drug Pricing Deal (Pink Sheet)
• New Korean Accounting Guidelines Aim For More Flexible Biopharma Practices (Scrip)
• Congo declares end of latest Ebola outbreak in east (Reuters)

• Sanofi and Jennifer Doudna-Founded Scribe Ink $1B CRISPR Cell Therapy Deal (Biospace) (Fierce) (BioPharmaDive)
• In survival mode, Exicure cuts to the bone — pausing all R&D and chopping headcount by 66% (Endpoints)
• Black, Hispanic patients are neglected by ‘one size fits all’ MS trials, Genentech aims to change that (Fierce)
• Ipsen becomes the latest pharma to expand in Ireland, with a $50M investment in its facility in Dublin suburbs (Endpoints)
• ArsenalBio lands $70M cash deal with cancer giant Genentech to develop cell therapy (Endpoints)
• Genentech pays $70M to access Arsenal’s armory of T-cell tools in quest for solid tumor CAR-T (Fierce)
• Burned by EU backtrack, Valneva flags talks with potential partner for next-gen COVID-19 shot (Fierce)
• Emergent wraps up purchase of Chimerix’s potential monkeypox treatment Tembexa (Fierce)
• Emergent closes on buying smallpox drug Tembexa from Chimerix with a $238M payment (Endpoints)
• Wuxi’s expansion tear rolls on with new high-potency oral production facility (Fierce)

• U.S. FDA to review fewer emergency use requests for COVID tests (Reuters) )Bloomberg) (FDA)
• FDA hands Philips its 5^th Class I recall of the year for faulty ventilators (Fierce) (MedTech Insight)
• BD launches research-use monkeypox test, plans EUA filing for clinical use (MedTech Dive)
• Seer Medical scopes out FDA nod for at-home epilepsy monitoring system (Fierce)

• Eli Lilly Becomes Latest Biopharma Sued for Age Discrimination (Biospace) (Law360)