Recon: US spending bill includes accelerated approval reform; Kite acquires Tmunity, Penn’s CAR-T research network

ReconRecon | 20 December 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pharma wins changes in bill regarding FDA’s accelerated approval (STAT) (Biopharma Dive)
  • FDA Places Clinical Hold on Entrada’s IND for Duchenne Muscular Dystrophy (Biospace) (Fierce) (Endpoints)
  • Congress reaches major health policy deal on Medicare, Medicaid, and pandemic preparedness (STAT)
  • Too Big To Succeed? Cytokinetics Heart Failure Trial Proves Too Much For FDA Committee (Pink Sheet)
  • Covid-19 Drove Record Increase in Medicare Spending on Lab Tests (Bloomberg)
  • Decentralized Trial Technologies An ‘Encumbrance’ For Site Personnel, US Survey Shows (Pink Sheet)
  • US Worries China Covid Outbreak Could Cause Virus Mutations (Bloomberg)
  • Fraud risk increased among Medicare DME suppliers who enrolled under pandemic waivers: GAO (MedTech Dive)
  • Cancer center leaders lay bare CAR-T makers’ struggles – and an unexpected laggard  (Fierce)
  • New compound shows promise in reversing dangerous fentanyl effects (Fierce)
In Focus: International
  • EC approves first allogeneic T cell therapy for rare post-transplant complication (Endpoints)
  • EMA Offers Weekly Updates On Getting Clinical Trial Portal Ready For Mandatory Use (Pink Sheet)
  • Gambia lawmakers say Maiden to blame for child kidney injury deaths (Reuters)
  • Viatris takes cue from Pfizer with expanded Medochemie pact to make medicines in Vietnam (Fierce)
Pharma & Biotech
  • Kite to buy Tmunity Therapeutics, Carl June’s troubled CAR-T startup (STAT) (Fierce)
  • Novartis’ Restructuring Claims 285 jobs in New Jersey (Biospace) (Endpoints)
  • Otonomy shuts up shop, lays off all employees after string of ear drug failures (Fierce)
  • The list of the worst biopharma CEOs of 2022: No ‘winner,’ just accountability (STAT)
  • Boehringer Ingelheim deepens its collaboration with Click Therapeutics in a deal worth $460M (Endpoints)
  • AbbVie adds depression indication to Vraylar's label months after Gonzalez touts $4B+ peak sales potential (Endpoints)
  • In yet another delay for the F-star buyout, CFIUS extends review of 'national security risks' (Endpoints)
  • Medical device makers drop products as EU law sows chaos (Reuters)
  • Minute Insight: Abbott Receives US FDA Clearance For Spinal Cord Stimulator (MedTech Insight) (Fierce)
  • Medtronic starts US robotic surgery trial in push to challenge Intuitive (MedTech Dive)
  • Novo Nordisk expands partnership with Amalgam Rx (MedWatch)
Government, Regulatory & Legal
  • Astellas, Pfizer Sue Sun to Block Copies of Xtandi Drug (Bloomberg)
  • Takeda, Azurity Sue Glenmark to Block Copies of Edarbi Drug (Bloomberg)
  • Pfizer Defeats Suit Challenging Diverse Student Fellowships (Bloomberg)
  • J&J subsidiaries accuse former Auris employees of stealing robotic surgery trade secrets (MedTech Dive)
  • Major NIH Health And Medical Study Returns First Results To 155,000 People (MedTech Insight)
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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