Recon: J&J halts Varipulse heart device launch following stroke reports; Seikagaku’s painkiller may require narrower indication and REMS

• J&J pauses US rollout of Varipulse heart device after stroke reports (Reuters)
• Another ‘JPM Week’ nears: Here’s my roadmap for biotech’s annual SF gathering (STAT)
• Medicare Expands Coverage of Eli Lilly’s Weight-Loss Drug (The Wall Street Journal)
• What’s in a Claim? The Federal Circuit Rules on Orange Book Patent Listings (FDA Law Blog)
• Seikagaku’s Pain Drug May Need More Tailored Indication, REMS For Approval (Pink Sheet)
• Digging Through The US FDA Guidance Blizzard (Pink Sheet)

• UK Biotech Startup Takes Aim at Weight-Loss Leaders Novo, Lilly (Bloomberg)
• Terry Smith Sells Diageo Stock on Weight-Loss Drugs Fears (Bloomberg)
• China discovers cluster of new mpox strain (Reuters)
• China says flu cases show signs of easing, respiratory infections still rising (Reuters)
• Shanghai kicks off plan to allow foreign-owned hospitals (Reuters)
• Aiolos team reunites with $411M for new biotech with obesity drugs from China (Endpoints)
• Roche's Chugai partners with Swiss ADC biotech Araris (Endpoints)
• African Regulators Reach Big WHO Milestones (Pink Sheet)
• Revamped Drug Reimbursement Reviews Expected In Canada Soon (Pink Sheet)
• PhRMA, EFPIA Threaten Japan Council Pull-Out Over Venture Fund Plan (Pink Sheet)
• Innovative Drugs At Center Of China’s 2024 Regulatory Efforts (Pink Sheet)
• EU Medical Device Regulations Face Torrent of Criticism In Public Consultation (MedTech Insight)

• German research team’s discoveries open new possibilities for patients with autoimmune diseases (STAT)
• In biopharma, mega-deals surged as VCs were more selective (STAT)
• Sergey Brin Backs Startups From Psychedelics to ‘Energy Islands’ (Bloomberg)
• Leyden Labs gets $70M to test if nasal sprays can help protect against viruses (Endpoints)
• Synaffix adds Boehringer and Mitsubishi Tanabe as ADC licensing partners (Endpoints)
• Numab extends its Series C; AnaCardio raises $19M for its heart failure drug (Endpoints)
• Versant unveils Light Horse with $62M and a partnership with Novartis (Endpoints)
• Gene editing startup Scribe Therapeutics lets go of staff as it preps for the clinic (Endpoints)
• Coave raises €32M Series A despite being two years away from the clinic (Endpoints)

• Is this the digital health M&A wave we’ve been expecting? (Endpoints)
• H1 buys General Catalyst-backed Ribbon Health (Endpoints)
• Boston Scientific to buy remaining Bolt Medical stake for up to $664M (MedTech Dive)
• Beta Bionics, maker of ‘bionic pancreas,’ files for IPO (MedTech Dive)

• Biden administration allows larger incentives for people who reduce meth use (STAT)
• Investors call on UnitedHealth to disclose human and economic costs of policies that limit care (STAT)
• US to build new stockpile of bird flu vaccine for poultry (Reuters)
• Medicare Negotiated Prices Likely ‘Spilling Over’ Into Commercial Market, Payers Say (Pink Sheet)