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April 10, 2023
by Joanne S. Eglovitch

Recon: US judges issue competing rulings on abortion pill, stoking confusion; Pear Therapeutics files for bankruptcy, lays off 170 staffers

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Texas judge suspends FDA approval of abortion bill; second judge protects access (Washington Post) (NYT) (Reuters) (STAT
  • Texas abortion pill ruling threatens FDA (Washington Post) (NYT) (Reuters) (Endpoints) (Axios)
  • White House plans support for drugstores, pharma in abortion pill battle (Reuters) (Bloomberg)
  • What’s Next For FDA In Face Of Opposing Mifepristone Injunctions (Pink Sheet)
  • Pfizer, hundreds of US drugmakers call for reversal of Texas abortion pill ruling (Reuters)
  • US FDA advisers to weigh full approval for Eisai-Biogen’s Alzheimer’s drug (Reuters)
  • FDA puts Molecular Templates’ multiple myeloma trial on partial hold-500 days after adverse event (Fierce)
  • FDA Real-Time Surveillance Not Practical For All Drugs, CDER’s Safety Surveillance Chief Says (Pink Sheet)
  • Samsung and Sandoz question FDA's 'research roadmap' for biosimilars development (Endpoints)
  • Contract manufacturer Phlow raises $36M to build out services (Endpoints)
  • White House Report Outlines ‘Bold Goals’ To Advance The Bioeconomy (MedTech Insight)
  • NIH’s Genome Chief Says Genomics Is Evolving and Docs need More Education on It (MedPage Today)
  • Research with exotic viruses risks a deadly outbreak, scientists warn (Washington Post)
In Focus: International
  • China Pushes Back at WHO Criticism Over Delayed Wuhan Data (Bloomberg) (Reuters)
  • GSK must pay AstraZeneca royalties on Zejula, UK court rules (Endpoints)
  • Brazil Publishes New Guidelines On Registering Medicines (Pink Sheet)
  • With Brukinsa launch, BeiGene seeks to avoid protracted pricing squabbles in Europe: exec (Fierce)
  • Chinese Gene And Cell Therapy, mRNA Developers Raise More Funds In March (Scrip)
Pharma & Biotech
  • Biotech leaders ‘cannot stay quiet’ as judge block abortion bill approval (Fierce)
  • In Another Round of Cuts, Biogen Lays Off Unspecified Number of Employees (BioSpace)
  • Biotech layoffs gather pace as industry downturn persists (BioPharma Dive)
  • Merck and Eisai's Keytruda/Lenvima combo fails PhIII trials for melanoma, colorectal cancer (Endpoints)
  • AbbVie, J&J Pull Two Accelerated Approvals for Imbruvica (BioSpace) (FDAnews) (Scrip)
  • Evotec shuts down IT systems in wake of cyberattack (Endpoints) (Fierce)
  • Clovis sells off remaining assets- including cancer drug Rubraca-for $70M-plus (Fierce)
  • After 2022’s M&A spree, Amgen CEO Bradway collects $21.4M payday (Fierce)
  • Vertex to Announce First Quarter 2023 Financial Results on May 1 (BioSpace)
  • Genentech probe of Marc Tessler-Lavigne paper finds no fraud evidence, but image ‘anomalies’ stay unresolved (Fierce) (STAT)
Medtech
  • Digital therapeutics maker Pear files for bankruptcy, lays off 170 staffers — including CEO (Endpoints) (MedTech Insight) (BioSpace)
  • EPA proposes stricter ethylene oxide pollutant rules for chemical makers (MedTech Dive)
  • FDA dubs Abbott’s FreeStyle Libre battery issues a Class I recall, spanning 4.2M devices (Fierce)
  • US FDA identifies recall of Philips’ respiratory devices as most serious (Reuters) (Fierce) (STAT)
  • Ultima Genomics combines ‘$100 genome’ tech with Genome Insight’s AI-powered analysis (Fierce)
  • Why won’t Illumina sell Grail? (MedtechDive)
Government, Regulatory and Legal
  • J&J Talc Suits’ Outside Funders Unveiled Via Little-Used NJ Rule (Bloomberg)
  • Amgen, Teva Get New Shot At Appeal of Sensipar Antitrust Ruling (Bloomberg)
  • Challenge to Minnesota’s Free Insulin Law Will Move Forward, Federal Court Rules (FDAnews)
  • Regeneron Pharma Sees Charge of About $56m on Sonoma Bio Pact (Bloomberg)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
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