Recon: FDA staff say safety issues for Biogen’s ALS drug don’t preclude approval; BioNTech partners with OncoC4 to develop immunotherapy drug

• California Picks Generic Drug Company Civica to Produce Low-Cost Insulin (KHN)
• ‘A safe place to fail’: ARPA-H chief on building a culture of risk-taking in science (STAT)
• Moderna CEO made $398 million in 2022, but still pledges to give most to charity (STAT)
• FDA staff says safety issues with Biogen's ALS drug to not prevent approval (Reuters)
• Wyoming governor signs law outlawing use of abortion pills (Reuters)
• Karuna's schizophrenia drug meets goal, safety doubts drag shares (Reuters) (Fierce) (STAT)
• US FDA classifies recall of heart devices by Getinge as most serious (Reuters)
• Novo Nordisk's diabetes drug Ozempic back in supply in US after months of shortage (Reuters)
• Sarepta slides as FDA about-turn on panel clouds gene therapy approval path (Reuters) (STAT)
• The high price of Ozempic is pushing many to unregulated, copycat drugs for weight loss (NBC)

• BioNTech signs deal to co-develop OncoC4's cancer drug (Reuters) (BioPharmaDive)
• EMA Management Board: highlights of March 2023 meeting (EMA)
• The ICH S12 Guideline reaches Step 4 of the ICH Process (ICH)
• MDR Amending Regulation Officially Published And Already In Force (MedtechInsight) (MedicalDevicesLegal)
• EU MDR Notified Bodies Reach 38 After Another Designation (MedtechInsight)
• ‘Skinny jab’ drug firm facing fresh inquiries after ‘serious breaches’ of industry code (The Guardian)
• WHO Accuses China of Hiding Data That May Link Covid’s Origins to Animals (NYTimes) (Reuters)
• Medicines regulator seeks to shake off UK ‘isolationist’ label with new alliance (FT)
• Takeda autoimmune therapy shows effectiveness in key trial (STAT)
• Vaccine makers prep bird flu shot for humans 'just in case'; rich nations lock in supplies (Reuters)

• Big Pharma lobbies for slice of US chip industry tax breaks (FT)
• Gilead scoops up Nurix’s IRAK4 degrader for up to $445M, plucking first fruit grown from 2019 collab (Fierce)
• Acer Therapeutics to pause trial of hot flashes drug (Reuters)
• A Diverse Culture From The Beginning At Early-Stage Biotechs (LifeSciVC)
• Zymeworks, Daiichi end $293M bispecific collab after 6 unfruitful years (Fierce)
• Samsung Biologics to kick off $1.5B+ plant construction in South Korea (Endpoints)
• Athenex's cash dries up as it faces clinical hold on cancer therapy in wake of patient death (Fierce)
• Rare Disease Body Wants EU Legislative Overhaul To Address Orphan Definitions & Incentives (Pink Sheet)
• Daiichi and Zymeworks end antibody pact after seven years (Endpoints)
• 'No finding of research misconduct': MIT ends 3.5-year review of biotech founder, professor Sasisekharan (Endpoints)

• Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail (MedtechDive) (CNBC)
• Pear market: Digital therapeutics maker eyeing a sale in last-ditch money-saving move after layoffs, stock sale (Fierce)
• BD, Visby Medical snag updated FDA nods for women's health PCR tests (Fierce)
• ‘Business as usual?’ Investors weigh in on future of medtech startup financing after SVB collapse (MedtechDive)
• FDA sets end date for raft of COVID-related shortages that began early in pandemic (MedtechDive)
• Olympus accused of ‘troubling disregard for patient safety’ by FDA after flurry of warning letters (MedtechDive)

• Elizabeth Holmes owes over $25 million to Theranos, lawsuit says (CNBC)
• J&J finalizes $25M settlement, laying Remicade antitrust allegations to rest (Endpoints)