Recon: Amgen settles patent suit over Stelara biosimilar; FDA approves Opiant’s opioid overdose nasal spray

• Amgen settles patent lawsuit over biosimilar of J&J's big-selling Stelara (Reuters)
• Weight-loss drug pioneers aim to jump on Wegovy bandwagon (Reuters)
• Congress weighs stiffer fentanyl regulations (Politico)
• FDA budget battles, prisons’ sobering Covid response & BIO’s CEO search is on (STAT)
• House FDA budget bill markup postponed (House Appropriations)
• California’s Fentanyl Problem Is Getting Worse (KFF)
• US FDA approves Opiant's spray for reversing opioid-related overdoses (Reuters) (FDA)
• Judge tosses out some claims in Abbott baby formula litigation (Reuters)
• Novo Nordisk, Pfizer weight-loss pills work as well as shots (Reuters)
• Under pressure from patients, FDA faces tough choices on experimental gene therapy (Boston Globe)

• EU Industry Wants ‘More Fluid’ Accelerated Assessment Procedure At EMA (Pink Sheet)
• Australian Regulator Warns Of Delays To GMP Clearance Processes (Pink Sheet)
• Canada Publishes Real World Evidence Guidance For HTA And Regulatory Decision Making (Pink Sheet)
• India makes tests mandatory for cough syrup export after overseas deaths (Reuters)
• Rich nations must do more to fight pandemics -WHO draft treaty (Reuters)

• India Clinical Trials Scenario: Leaders From Novartis, IQVIA, PwC Signal Winds Of Change (Pink Sheet)
• Expect More Temporary Members Voting In US FDA Advisory Committees (Pink Sheet)
• Americans may not understand survival nuances in cancer brand commercials, FDA research finds (Endpoints)
• One-fifth of late-stage cancer trials changed primary endpoints after trial start, JAMA Network Open study says (Endpoints)
• Blueprint's Ayvakit picks up long-awaited FDA approval in indolent systemic mastocytosis (Fierce)
• Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects (EMA)
• Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 10 - 12 May 2023 (EMA)
• Affimed lays off around 50 staffers as it brings combo NK cell therapy to PhII (Endpoints)
• An early-stage fail highlights ongoing ALS drug development challenges, despite recent Biogen OK (Endpoints)
• PhIII win for smoking cessation treatment puts Achieve Life Sciences on path to FDA, jazzes up deal talks (Endpoints) (STAT)
• Icosavax pushes forward combo RSV-hMPV vaccine and announces direct stock offering (Endpoints)
• CohBar, Morphogenesis link up in reverse merger of two cancer biotechs (Endpoints)
• Roche scraps second mid-stage schizophrenia trial in as many years (Endpoints)

• Orthopedic markets to return to normal this year as post-pandemic boost fades: analysts (MedtechDive)
• Abbott submits dual-chamber leadless pacemaker for FDA review after study success (Fierce)
• ICU Medical faces Class I recall of infusion system replacement batteries (Fierce)
• How And Where Tougher Clinical Evaluation Measures Under EU MDR Cause Challenges (Medtech Insight)
• PulseAI algorithm beats Apple Watch software at detecting atrial arrhythmias (MedtechDive)
• Bioventus seals up $85M sale of wound care business to LifeNet Health (Fierce)

• Sandoz Sues To Invalidate Prostate Cancer Drug Patent (Law360)
• What Will FDA Do If Supreme Court Curtails Chevron Deference? (Pink Sheet)
• What IP Attys Should Know About Enablement After Amgen (Law360)
• Teva Accused Of Asthma Inhaler Antitrust Scheme (Law360)