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

ReconRecon | 27 September 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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 5th 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)
Government, Regulatory & Legal
  • Eli Lilly Becomes Latest Biopharma Sued for Age Discrimination (Biospace) (Law360)
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.

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