Recon: Biogen CEO to step down as drugmaker curbs spending on Alzheimer’s drug; FDA restructures device center, adding two health tech offices
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- 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)
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