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

ReconRecon | 03 May 2022 |  By 

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.

A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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