Recon: FDA urges federal judge to reject Texas lawsuit challenging abortion pill; EU, Israeli regulators find no stroke signal with Pfizer COVID shot

ReconRecon | 19 January 2023 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA argues public harm if court reverses abortion pill approval (The Hill) (Endpoints) (Bloomberg) (Fierce)
  • Merck discovers 'root cause' of nitrosamine levels in blockbuster diabetes drugs (Endpoints) (Fierce)
  • Diversity in Clinical Trials as FDA Gets a Boost From New Law (Bloomberg)
  • FDA’s Novel Approvals Again Led By Oncology And Neurology, But Dermatology Also Shone In 2022 (Pink Sheet)
  • HHS needs better oversight of research that alters pathogens, government watchdog says (STAT) (Bloomberg)
  • Updated: FDA slaps Optum Infusion with a warning letter over 'insanitary' production conditions (Endpoints)
  • Lab-leak fears are putting virologists under scrutiny (Washington Post)
In Focus: International
  • EU drug regulator has not seen signal of possible Pfizer shot stroke link (Reuters)
  • Israel says has not found a link between Pfizer COVID shot and stroke (Reuters) (USNews)
  • EMA Confirms CTIS Ready For Mandatory Use By 31 January Deadline (Pink Sheet)
  • Will the European Union give vouchers to pharma to develop badly needed antibiotics? (STAT)
  • China's Shrinking Population Poses New Challenge For Pharma (Pink Sheet)
  • Pharmalittle: India regulator finds 5% of drug samples are substandard; EMA claims new clinical trial registry is fixed (STAT)
  • WHO Plans New Body To Boost Novel TB Vaccine Efforts (Pink Sheet)
  • Covid Immunity Lasts at Least a Year After Infection Plus Shots (Bloomberg)
Pharma & Biotech
  • J&J packs up HIV vaccine after failing phase 3 trial (Fierce) (Reuters) (STAT) (Endpoints)
  • India’s Sun Pharma acquires U.S.-based Concert for $576 mln (Reuters)
  • Moderna RSV Vaccine Prevents Most Cases in Final-Stage Trial (Bloomberg)
  • Sanofi seeks to launch blood disorder drug this year, CNBC reports (Reuters)
  • Merck KGaA Is Looking for Deals with €20 Billion War Chest (Bloomberg)
  • Amgen extends autoimmune pact with small Michigan biotech (Endpoints)
  • ReNeuron lays off 40% of staff after funding failure, buying time to execute exosome pivot (Fierce)
  • How 2 biotechs survived 2022’s rocky market -- and why their CEOs see success on the horizon (Fierce)
  • JPM23: Ipsen CEO happy to take on Big Pharma in rare diseases but says gene therapy is rife with risk (Fierce)
  • Bluebird extends cash runway to late 2024 with $113M raise through stock sale (Fierce) (Biospace)
  • Mineralys polishes $100M IPO plans ahead of phase 3 in hypertension (Fierce)
  • Horizon claims mid-stage victory in rare disease, lines up PhIII for new owners at Amgen (Endpoints)
  • Phase 2 attrition jumps amid widespread scale-back in overall clinical trial activity: study (Fierce)
  • Gilead fosters growth with plans for new research center in California hometown (Fierce)
  • Pfizer bolsters North Carolina manufacturing footprint with Abzena plant purchase (Fierce)
  • By summer solstice, we'll know the fate of Intercept's NASH drug (Endpoints)
Medtech
  • US FDA’s Long Wait For Diagnostics Reform Legislation Continues (Pink Sheet)
  • Commission Removes Warning Signs Relating To Four EU MDR Notified Bodies (MedTech Insight)
  • Abbott’s FDA approval for TAVI device tees up challenge to Edwards, Medtronic: analysts (MedTech Dive)
  • Medtech hazards: Problems with Philips’ recall put safety of home-use devices at top of danger list (MedTech Dive)
  • JPM23: Big data, staffing shortages and M7A slowdowns, oh my! The trends at the top of medtech execs’ minds (Fierce)
  • Bayer to buy AI imaging platform Blackford Analysis to bolster radiology growth strategy (MedTech Dive) (Fierce)
  • PAVmed and its Lucid Diagnostics, Veris health subsidiaries lay off 205 of staff (Fierce)
Government, Regulatory & Legal
  • J&J, Mentor Denied Early Exit From Breast Implant-Cancer Suit (Bloomberg)
  • Walgreens, West Virginia Reach $83m Opioid Settlement (Bloomberg)
 
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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