Recon: Biogen CEO to step down as drugmaker curbs spending on Alzheimer’s drug; FDA restructures device center, adding two health tech offices

• Another Pfizer gene therapy is free of FDA hold, but delay continues (Fierce)
• A year after CRL, Acadia is going back to bat for Nuplazid at the FDA (Endpoints)
• As expected, FDA spikes down Axsome migraine med, but issues are ‘addressable’ (Fierce)
• Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill (The Pink Sheet)
• Bipartisan letter to Merrick Garland warns of opioid overdose drug shortages (Endpoints)
• Is the FDA taking advice from its expert panels? A new analysis points to inconsistencies in the process (STAT)
• Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs (The Pink Sheet)
• Moderna’s COVID-19 Second Booster Authorization Largely Thanks To Pfizer/BioNTech Data (The Pink Sheet)
• Califf On Getting Someone Younger Than 70 To Take FDA Commissioner Job (The Pink Sheet)
• Paxlovid’s failure as a preventative measure raises questions, but doctors still back it as a therapeutic (STAT)

• Medicines Access In Ukraine Severely Hit By Ongoing Conflict (The Pink Sheet)
• EU Ready to Spend $2.6 Billion on Hub for Health-Care Data (Bloomberg)
• At least 228 probable cases of child hepatitis so far: WHO (Reuters)
• Pfizer keeps COVID sales forecast unchanged as pandemic curbs ease (Reuters)
• WHO to hold urgent meeting on Ukraine invasion's health impact (Reuters)
• UN committee urges wealthy nations to honor human rights and widen access to Covid vaccines (STAT)

• Bayer wins U.S. priority review of drug against metastatic prostate cancer (Reuters) (Financial Post)
• Biogen to replace CEO as it ‘substantially’ curbs spending on its Alzheimer’s drug (STAT) (Reuters) (Biospace)
• Pfizer Leans Heavily on COVID-19 Vaccine, Treatments in Q1 (Biospace)
• Biotech’s biggest investor is prepping a whopping $4.75B wager on the future of the industry (Endpoints)
• Genesis and Lilly Ink AI Collab Worth Up to $670M  (Biospace)
• Tackling toxicity, Tubulis lands $63M to advance ADC pipeline spearheaded by Adcetris rival (Fierce)
• Bad news from FDA prompts Spero to lay off 75% of staff, drop UTI drug (Fierce) (Biospace) (Endpoints)
• 5AM, Avidity, Fidelity lead $100M infusion into next-gen, targeted complement approach (Endpoints)
• What Scientists Know About the Unusual Hepatitis Cases in Children (New York Times)
• Wait, what? Oracle tech founder Larry Ellison invests into ex-stealth genomics diagnostics biotech (Endpoints)
• Pliant Therapeutics Receives FDA Fast Track Designation for PLN-74809 for the Treatment of Idiopathic Pulmonary Fibrosis (Biospace)

• FDA Expands OPEQ ‘Super Office’; Splits In Vitro Diagnostics, Radiological Health Office In Two (MedTech Insight) (Inside Health Policy)
• CDRH proposes requirement for Philips to submit recall plan for sleep-apnea, ventilator devices (MedTech Dive)
• New IVDR Notified Body Named After A Nine-Month Gap (MedTech Insight)
• FDA Clears J&J’s Ethicon Monarch Robotic System For Urology Procedures (MedTech Insight)
• Wearable, AI-powered whole breast ultrasound system cleared by the FDA (Fierce)
• FDA plays tooth fairy, awards clearance to VideaHealth’s cavity spotting AI (Fierce)
• Nanox nets FDA clearance for osteoporosis and spine fracture AI (Fierce)

• Fifth individual charged in conspiracy to steal GlaxoSmithKline trade secrets, faces up to 10-year sentence (Endpoints) (Biospace)
• Teva, Lupin Settle Patent Suit on Austedo Movement Disorder Drug (Bloomberg)
• Opioid distributors reach $518 million settlement with Washington state (Reuters)
• Teva Pharm sees nationwide U.S. opioid settlement in 2022 (Reuters)