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)
- 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)
- 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)
- 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)
- 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)
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