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

• 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)

• 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)

• 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)

• 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)