Recon: FDA approves Chiesi’s rare skin disease gel; Merck snags priority review for pneumococcal jab
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- U.S. government spent more on health care in 2022 than six countries with universal health care combined (STAT)
- Pfizer no longer going to conduct interim analysis for Duchenne gene therapy study by end of year (STAT)
- Merck clinches priority review for pneumococcal vaccine, raising stakes for Pfizer (Endpoints)
- Grail CEO predicts ‘transformative’ 2024 amid Illumina split (MedTech Dive)
- Biden administration asks judge to toss out Humana’s Medicare Advantage audit lawsuit (STAT)
- Here are the worst biopharma CEOs of 2023 (STAT)
- FDA approves Chiesi’s gel for rare skin disease after initial 2022 rejection for Amryt (Endpoints)
- Amy Abernethy to step down as Verily’s chief medical officer in latest departure from company (STAT)
- In the U.S., scientists see barriers to the development of CAR-T therapies. In Spain, a hospital brews its own (STAT)
- WHO classifies JN.1 coronavirus strain as 'variant of interest' (Reuters)
- Firms Get More Time To Choose Between UK Voluntary & Statutory Drug Pricing Schemes (Pink Sheet)
- How The ACCESS Consortium’s New ‘Promise Pathway’ Can Benefit Drugmakers (Pink Sheet)
- EMA Consults On Using Specific Follow-Up Questionnaires To Improve Safety Reports (Pink Sheet)
- Prime Medicine, Mukherjee’s Myeloid Therapeutics clash over genome-editing deal (STAT)
- Aldeyra Therapeutics' skin disease drug succeeds in mid-stage study (Reuters)
- Lilly, Novo’s bet on heart disease starts to take shape, and 2024 could be a pivotal year for their GLP-1s (Endpoints)
- Exclusive: Metabolic health and primary care startup knownwell raises $20M Series A round (Endpoints)
- Lassen Therapeutics reels in $85M Series B for PhII testing in thyroid eye disease (Endpoints)
- Bluebird in fundraising mode: A $150M public offering and a deal to get cash early from gene therapy sales (Endpoints)
- Kronos stops work on leukemia drug; Aldeyra shares rally on eczema data; Atavistik Bio's $40M (Endpoints)
- MarketingRx roundup: Vertex, CRISPR get unintended role in SNL skit; Real Chemistry and cancer society debut AI effort (Endpoints)
- Twilight Of The Opioids? Label Updates, Review Changes May Have Less Impact Than Shrinking Pipeline (Pink Sheet)
- OPDP’s One-Two Combo on Quantitative Efficacy Claims in DTC Ads (FDA Law Blog)
- Apple pauses sales of latest watches in the U.S. after ITC decision (STAT)
- Health care industry fights back against crackdowns on health data tracking (STAT)
- Activist Icahn prepares a second board challenge at Illumina -letter (Reuters)
- Roundup: Medtech M&A slump continues but analysts predict uptick in 2024 (MedTech Dive)
- MTI 100: Macro Challenges Make Demands Of Newly Resilient Medtechs (MedTech Insight)
- Industry Calls For Important Preconditions For Eudamed In Hope Of Early Release (MedTech Insight)
- Starting The Discussion Ball Rolling On The EU’s New Medtech Regulatory Governance Structure (MedTech Insight)
- FDA drafts guidance outlining real-world evidence for medical device submissions (MedTech Dive)
- Inspection Overhaul Is Early Test Of US FDA’s ‘Digital Transformation’ (Pink Sheet)
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