Recon: Pfizer, Flagship to invest $100M in drug discovery effort; Medtronic recalls nearly 350,000 ICDs due to low shock risk

• J&J sues US govt to halt Medicare drug price negotiation plans (Reuters)
• Pfizer, Flagship Pioneering to invest $100 mln in drug discovery (Reuters) (Endpoints)
• Medtronic recalls nearly 350,000 defibrillators for risk of reduced shock (MedtechDive)
• Biden’s HIPAA expansion for abortion draws criticism, lawsuit threats (Politico)
• Medicare has a new plan to address drug shortages — but it could backfire (STAT)
• Key House panel plots a new health care package — complicating the chamber’s agenda (STAT)
• CMS proposes broader coverage of PET scans for Alzheimer's patients (Reuters)
• After yearlong delay, FDA completes inspection for Novartis, BeiGene's anti-PD-1 drug from China (Endpoints)
• Bipartisan group of senators seeks to eliminate interchangeability designation for biosimilars (Endpoints)

• Novartis buyback offers partial cure for M&A risk (Reuters)
• Novartis raises 2023 forecast, maps out Sandoz spin-off (Reuters)
• Novartis is scolded by U.K. trade group for the third time this year over Entresto marketing (STAT)
• MHRA launches public consultation on reclassification of opioid-containing cough medicine (MHRA)
• EMA to drug developers on AI: Carry out thorough risk assessments (Endpoints)
• European Commission Spells Out New MDR/IVDR Extensions For Authorities Beyond EU (MedtechInsight)
• Medical gear maker Getinge's core profit halves on quality and supply issues (Reuters)

• Sanofi expands research deal with gene editing startup Scribe (BioPharmaDive)
• Cell And Gene Therapy Companies Fear More Market Delays From EU’s Single Review Plans (Scrip)
• Softbank-backed Neumora's depression drug cuts symptoms in mid-stage trial (Reuters)
• GSK Pulls EU Filing For Jesduvroq In CKD Anemia After Label Narrowed (Pink Sheet)
• Drug developer 9 Meters Biopharma files for bankruptcy protection (Reuters)
• AstraZeneca bails on failed Pieris asthma asset, forcing the biotech to restructure, lay off 70% of staff (Fierce)
• Argenx launches $750M offering after PhII data drop (Endpoints)
• GSK yanks 2 batches of its asthma blockbuster Nucala in Taiwan over glass particle fears (Fierce)
• Mirum snaps up 2 liver disease drugs from Travere for up to $445M (Fierce)
• Novartis axes secretive obesity program after high-risk, high-reward bet fails (Fierce)
• After Long Regulatory Run, Sanofi’s Dupixent Set To Transform India AD Market (Scrip)

• As digital health tech proliferates, a new institute aims to cut through hype (STAT)
• Beckman Coulter, Fujirebio partner on gold rush for Alzheimer’s blood tests (Fierce)
• Masimo plans cost cuts as Q2 revenue falls short of expectations (MedtechDive) (Fierce)
• Big Health buys Limbix to add adolescent depression app to digital therapeutic portfolio (MedtechDive)
• ViewRay files for Chapter 11 bankruptcy (MedtechDive)
• Downturn In Demand For EU Medtech Regulatory Talent Starting To Turn Around (MedtechInsight)
• MediView XR receives 510(k) clearance for AR surgical navigation platform (MobiHealthNews)

• Winchester Man and Former Medical Device Sales Rep Arrested for Defrauding Boston Hospital and Lying to Federal Authorities (FDA)
• FTC Seeks Pause Of $28B Amgen Deal Amid Challenge (Law360)
• US judge rejects $45 mln award to CareDx in Natera false ads case (Reuters)
• PMA Preemption Guts Ohio Case Down to Narrow Failure to Warn Claim (Drug & Device Law)
• Gilead, Teva Document Disclosures Helped Sway Jury In Rare Pay-For-Delay Trial (Pink Sheet)
• FTC Moves To Block IQVIA Deal Over Health Ad Concerns (Law360)