Recon: FDA rejects AbbVie Parkinson’s treatment over manufacturing concerns; AstraZeneca’s Imfinzi fails in Phase 3 lung cancer trial

• Senators push Medicare for a PET scan pay bump (STAT)
• One firm, two conflicting takes on Alnylam’s HELIOS-B (STAT)
• Experts split on whether Eli Lilly’s Zepbound will hamper CPAP sales (STAT)
• Turning a ‘no’ vote into progress: How to advance MDMA-assisted psychotherapy for PTSD (STAT)
• FDA again rejects AbbVie's continuous infusion therapy for Parkinson's (Endpoints) (Reuters)
• J&J's Tremfya fails giant cell arteritis study, where Roche and AbbVie have succeeded (Endpoints)
• US Supreme Court rejects challenge to $2.7 bln Blue Cross settlement (Reuters)
• US Patent Office Plan To Expand Settlement Disclosure Requirements Welcomed By FTC (Pink Sheet)

• U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer (STAT)
• AstraZeneca's Imfinzi fails in late-stage trial to treat certain lung cancers (Reuters)
• Merck KGaA shares plunge after cancer drug hopeful fails (Reuters)
• UK's NHS says hackers have published data stolen in ransomware attack (Reuters)
• EU Cross-Border Access Laws Present ‘Unique Challenges’ For ATMPs (Pink Sheet)
• More Cracks Appear In EU Pharma Reform As Ministers Debate RDP Proposals (Pink Sheet)

• A biotech’s binary bet ends badly (STAT)
• Teva launches generic version of Novo Nordisk's diabetes drug Victoza (Reuters)
• New cancer biotech emerges from Stanford research, with help of Nobel laureate Carolyn Bertozzi (Endpoints)
• Wave Life Sciences touts Huntington's disease win in Phase 1b/2a trial (Endpoints)
• Zealand Pharma aims to raise $900M; Boehringer discontinues three Phase 2 trials (Endpoints)
• Ginkgo to cut at least 35% of staff in multi-year restructuring plan (Endpoints)
• Teva launches generic version of Novo Nordisk's diabetes drug Victoza (Reuters)

• Grail, aiming to market a blood test for cancer, faces host of challenges as it debuts on Nasdaq (STAT)
• The eye in the sky: Intraoperative neurophysiological monitoring and associated malpractice risks (Reuters)
• Embecta touts its insulin patch pump at ADA (MedTech Dive)
• Senseonics tips 365-day CGM to double 2025 sales (MedTech Dive)
• Insulet seeks label expansion of Omnipod 5 for Type 2 diabetes (MedTech Dive)
• Orthofix’s president of global orthopedics resigns (MedTech Dive)

• Ateev Mehrotra, the researcher the telehealth lobby loves to hate, isn’t backing down (STAT)
• Tackling administrative harm can yield better decisions for better care (STAT)
• Exclusive: Cityblock Health investors buy employee shares in tender offer (Endpoints)
• US swimming stars testify on anti-doping measures ahead of Olympics (Reuters)
• US law firm Motley Rice appeals $396 mln opioid fee award (Reuters)
• US Supreme Court gives pharma companies a chance to thwart terrorism-funding lawsuit (Reuters)
• US Medicare Agency Reconsidering Proposed Accelerated Approval Payment Demo (Pink Sheet)
• HPM Director Dara Katcher Levy to Present Webinar on AMCP Format for Formulary Submissions v5.0 (FDA Law Blog)