Recon: FDA grants accelerated approval to Biogen ALS treatment; Novartis chief criticizes EU plans for compulsory licensing

• FDA approves new treatment from Biogen for rare form of ALS (STAT) (FDA)
• Biogen trims pipeline programs to cut costs, focus on Alzheimer's drug launch (Reuters)
• GE HealthCare revenues expand as supply chain issues ease (Fierce)
• Labcorp misses profit estimates as drug development unit struggles (Reuters)
• Sens. Bernie Sanders, Bill Cassidy reach deal on PBM, generic reform (STAT) (Endpoints)
• Johnson & Johnson to price shares of consumer spinoff Kenvue at $20 to $23 in IPO (CNBC)
• Maryland pushes first-of-its-kind bill to promote alternatives to animals in biomedical research (STAT)

• Novartis chief criticises EU move to control pharma licensing in emergencies (Financial Times)
• Novartis, helped by cost cuts, raises full-year outlook (Reuters) (Bloomberg)
• WHO says contaminated cough syrup made in India found in Western Pacific (Reuters)
• Two-for-one prescription changes to save Australian patients more than $1.6bn (The Guardian)
• AstraZeneca overtakes Pfizer as crunch week for UK pharma looms (The Guardian)
• MHRA Chair Stephen Lightfoot Standing Down (MHRA)
• Can Africa Get Close to Vaccine Independence? Here’s What It Will Take. (NYTimes)
• Samsung Biologics to expand manufacturing in South Korea; WuXi AppTec expects up to 7% revenue growth this year (Endpoints)
• China to replace PCR test requirement with antigen test for inbound travelers (Reuters)

• Mpox outbreak was wake-up call for smallpox preparation, vaccine maker Bavarian Nordic says (CNBC)
• No Vote, No Mandate? FDA Opioid Meeting Shows Limits Of Non-Voting Panels (Pink Sheet)
• How To Prevent Parenteral Drug Shortages As Sterilizer Capacity Tightens (MedtechInsight)
• Vertex buys in on Stablix's protein stabilization approach in research and licensing deal (Endpoints)
• India's Serum to double investment in Biocon's unit to $300 mln (Reuters)
• India's Ipca Laboratories sinks to 3-yr low after Unichem Lab deal (Reuters)
• From CRL to buyout in five months: Assertio to acquire Spectrum in $248M stock deal (Endpoints)
• FDA hands Arbutus clinical hold on IND for hepatitis PD-L1 (Endpoints)
• Morphic study shows promise — and blockbuster potential — for a pill to treat ulcerative colitis (STAT)
• Pfizer-backed Vedanta Biosciences lands $106M for PhIII in C. diff, PhII in IBD (Endpoints)
• Ideaya goes forward with $150M offering after touting PhII cancer data (Endpoints)
• Florida-based biotech with approved cardiovascular therapy moves to go public via SPAC (Endpoints)
• How clinical trial advertising went from old-school tactics to splashy strategies to compete in a fierce market (Endpoints)
• Novartis says no liver toxicity seen so far its BTK inhibitor (Reuters)
• Biotech firm raises $2.2 mln in first Russian IPO this year (Reuters)
• With little FDA oversight, melatonin supplements vary widely in actual dosage, study finds (STAT)

• Are Notified Bodies AI-Ready? BSI Teams Up With Expert Firm On Conformity Assessments (MedtechInsight)
• Axonics acquires hardware-software combo to improve neuromod placements (Fierce)
• Insulet's 3-day insulin pod for Type 2 diabetes scores FDA clearance (Fierce)
• Danaher cuts annual sales growth forecast on biotech funding woes (Reuters)

• Device maker Medtronic blasts rival's 'threadbare' antitrust lawsuit (Reuters)