Recon: Amgen settles patent suit over Stelara biosimilar; FDA approves Opiant’s opioid overdose nasal spray
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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