Recon: EU regulators investigating Ozempic, Saxenda after reports of possible suicide risk; BeiGene invests in solid tumor ADCs in $1.3B licensing deal

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• Iovance, familiar with the long way around, gets FDA OK to pursue accelerated review for lung aner therapy (Fierce)
• FDA Puts Clinical Hold on Hemogenyx’s CAR-T AML Therapy (BioSpace)
• FDA Allows More Cancer Drug Imports from China Amid Shortage (Bloomberg)
• After Leqembi Approval, US FDA In No Rush To Declare Amyloid A Validated Surrogate Endpoint (Pink Sheet)
• US FDA Novel Approvals Total 35 In First Half 2023, Riding Resurgent Biologics Wave (Pink Sheet)
• Using A Natural History Study As An External Control In Rare Diseases: Ipsen Offers An Example (Pink Sheet)
• NIH’s $50 Billion Procurement Had ‘Self-Score’ Evaluation Flaws (Bloomberg)
• Biden’s NIH nominee is languishing in Congress — alarming public health advocates (STAT)
• CDC to reduce funding for states’ child vaccination programs (Endpoints)
• Cigna to add three Humira biosimilars to drug reimbursement list (Reuters)
• The new weight loss drugs are revolutionizing our understanding of desire. Food cravings could be just the beginning (STAT)

• EU investigates Ozempic, weight-loss drug Saxenda after suicidal thoughts reported (Reuters) (Endpoints) (Fierce)
• Europe faces long wait for weight-loss drugs as governments eye costs (Reuters)
• No More Pandemic-Related Regulatory Flexibilities For Companies In EU (Pink Sheet)
• EU Addresses Concerns Over Switching Multinational Studies To Clinical Trials Regulation (Pink Sheet)
• UK health regulator approves GSK's vaccine for common respiratory virus RSV (Reuters)
• UK MHRA To Focus On Risk-Proportionate Regulation & Greater Patient Involvement (Pink Sheet)
• Canada To Introduce US/EU-Style Pediatric Development Plan Rules (Pink Sheet)
• Novavax to receive $350M from Canada for cancelled COVID vaccine orders (Fierce)

• BeiGene links future to DualityBio, inking backloaded $1.3B deal for solid tumor ADC (Fierce) (BioSpace) (Endpoints)
• J&J capitalizes on Nanobiotix cash crunch to capture late-phase cancer candidate for $30M upfront  (Fierce)  (BioSpace) (Endpoints)
• Merck, Moderna unveil phase 3 trial details for closely watched mRNA cancer vaccine (Fierce) (Endpoints)
• Samsung Biologics, after expanding Pfizer collab, inks Novartis production deal worth $391M  (Fierce)
• WuXi Biologics seeks spinout, HK listing of bioconjugates-focused joint venture (Endpoints)
• Fulcrum inks discovery deal with Camp4 Therapeutics (Endpoints)
• GSK dives even deeper into oligo strategy with Elsie Biotechnology pair-up (Fierce)
• Sumitomo will lay off 62 New York workers after consolidating seven subsidiaries (Endpoints)
• Pfizer adds shifts, invests resources to cope with surge in demand for syphilis treatment (Endpoints)
• Nymox faces rebellion led by former executives over stalled del, Nasdaq delisting (Fierce)
• Lilly’s Prevail revises $2.6B biobuckss deal with Precision to take on more preclinical work (Fierce)
• CRISPR helps solve 100-year mystery of why cancer cells have extra chromosomes (Fierce)

• Countdown Starts On Great Britain’s Move To Accept Medtech Registered Overseas (MedTech Insight)
• Article 97 Derogation No Longer Such An Option Given EU Medical Device Amending Regulation (MedTech Insight)
• Companies Must Establish A ‘Realistic Value Proposition’ For AI Products, NICE Says (MedTech Insight)
• FDA Alerts Industry On GUDID Compliance (MedTech Insight)
• Outset Medical faces FDA warning letter over hemodialysis labeling, accessories (Fierce)
• Galvanize Therapeutics lays off employees as new study of pulsed electric field tech ramps up (Fierce)
• First Notified Body In Cyprus Named Under Medical Device Regulation (MedTech Insight)
• Chatbots Are Not Ready To Be Medical Devices, Experts Argue (MedTech Insight)

• Novartis Falls as Judge Rules Entresto Patent Claim Invalid (Bloomberg) (Fierce)
• US appeals court revives Axonics challenges to Medtronic device patents (Reuters) (Bloomberg)
• Diabetes Drugmakers Say Judgment Proper in Heart Failure Suits (Bloomberg)
• Novo Nordisk files second round of lawsuits against compounding pharmacies hawking illegal semaglutide (Endpoints)