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March 7, 2024
by Jason Scott

Recon: Boehringer slated to cap asthma inhaler costs at $35 a month; Novo surges on early-stage obesity drug data

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

In Focus: US
  • Biden to propose expanding Medicare drug price negotiation in State of the Union (STAT)
  • Drugmakers gear up for joint IRA arguments as PhRMA appeals Texas verdict (Endpoints)
  • Senate panel advances bill to ban some Chinese biotechs, with Sen. Paul taking up industry’s cause (STAT)
  • A deep dive into Applied Therapeutics’ data, and questions on Cassava’s erased data (STAT)
  • Boehringer Ingelheim to cap asthma inhaler out-of-pocket costs at $35 (STAT)
  • FDA sees success in model-informed drug development pilot (Endpoints)
  • Valisure pressures FDA to recall acne treatments after finding carcinogen (Endpoints)
  • How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials (FDA Law Blog)
  • Lilly finds bacteria, other impurities in Mounjaro, Zepbound knockoffs (Reuters)
  • Astra-Sanofi's RSV therapy 'highly effective' against infant hospitalizations, CDC study shows (Reuters)
In Focus: International
  • Novo Nordisk’s obesity pill bests Wegovy in early trial (STAT) (Reuters) (Endpoints)
  • WTO proposal for Covid diagnostics and therapeutics waiver is abandoned (STAT)
  • WHO flags increasing resistance to GSK's HIV med Tivicay in some countries (Fierce Pharma)
  • AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ (Fierce Pharma)
  • Generics Group Urges Action On Licensing Delays As MHRA Unveils Guidance For Established Products (Pink Sheet)
  • Cut In Data Protection Looms Large As EU Vote On Pharma Revision Nears (Pink Sheet) (Pink Sheet)
Pharma & Biotech
  • UCB ups the ante with CDMO Samsung Biologics, signing $353M deal (Fierce Pharma)
  • Merck KGaA exits BTK inhibitor race, will focus on ‘external innovation’ (Endpoints)
  • GSK declares second PhIII win for Blenrep combo in bid to revive drug (Endpoints)
  • Sun Pharma re-enlists popular ‘Pimple Popper’ doctor for acne brand TV campaign (Endpoints)
  • Tarsus’ eye drops interrupt an animated mite 'party’ in first DTC ad for Xdemvy (Endpoints)
  • Early-stage oncology startup Boundless Bio files for IPO (Endpoints)
  • Sumitomo to lay off about 400 employees, reshuffle execs in North America as sales disappoints (Endpoints)
  • Evonik, looking to cut costs, shrinks workforce by 2,000 in structural overhaul (Fierce Pharma)
  • Growing Almac boosts capacity for manufacturing peptides and packaging commercial products (Fierce Pharma)
  • Argonaut's journey continues with $45M in new financing for facility expansion (Fierce Pharma)
Medtech
  • Oracle Health chair says Cerner isn’t competing with Epic (STAT)
  • Health tech investors outline investment priorities in AI (Endpoints)
  • Vicarious presses forward with soft tissue robot despite struggles (MedTech Dive)
  • Dexcom receives FDA clearance for first OTC glucose sensor (MedTech Dive)
  • Smiths Medical recalls nearly 86,000 syringe pumps over software problem (MedTech Dive)
Government, Regulatory & Legal
  • Former medical device CEO who sold dummy, plastic parts convicted of fraud (STAT)
  • Advisory Committees: US FDA Standardizing Decisions On When To Vet Applications (Pink Sheet)
  • FDA finds lead contamination in certain ground cinnamon products, asks manufacturers to voluntarily recall items (The Hill
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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