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February 13, 2024
by Jason Scott

Recon: Pharma lawsuit challenging Medicare drug price negotiations dismissed; BioAge raises $170M for obesity combo

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

In Focus: US
  • Biogen sees flat 2024 sales, pick up in Alzheimer's drug demand (Reuters)
  • A California court is setting a dangerous precedent over drug development (or lack thereof) liability (STAT)
  • Judge tosses PhRMA lawsuit over Medicare power to negotiate drug prices (STAT) (Reuters)
  • ‘Sleeper Issue:’ How Part B Drugs May Be Impacted By Medicare Part D Redesign (Pink Sheet)
  • US FDA Oncology Diagnostics Pilot Is ‘Interim Step’ To Fill VALID Void, But ‘Stuck In Neutral’ (Pink Sheet)
  • Biogen sees flat 2024 sales, pick up in Alzheimer's drug demand (Reuters)
In Focus: International
  • LianBio to shutter, ending Shanghai-based startup’s transatlantic ambitions (Endpoints)
  • Mexico Launches ‘Regulatory Certainty Strategy’ For Biosimilars (Pink Sheet)
  • WHO Tightens Up Guidance On Reserving Most Critical Antimicrobials For Humans Only (Pink Sheet)
  • Swissmedic Asks Sponsors For At Least Four Months’ Notice Ahead Of New Drug Filings (Pink Sheet)
  • Implementing The MDR And IVDR: Checkered History Signposts Need For Revised Approach (MedTech Insight)
  • Progress Made With HTA Regulation Implementation Plan (MedTech Insight)
Pharma & Biotech
  • Stem cell study offers clue to South Asians’ increased risk of cardiovascular disease (STAT)
  • Eli Lilly partner BioAge raises $170 mln for obesity treatment (Reuters) (STAT)
  • Ebola vaccine cuts fatality even in people who were infected before the jab, new study shows (STAT)
  • Was Pfizer’s ‘Here’s to Science’ commercial during the Super Bowl a winning play or a fumble? (STAT)
  • Pfizer’s Super Bowl Commercial Departs From Drug Ad Format (Pink Sheet)
  • KalVista pill reduces swelling symptoms caused by genetic disease, achieving goal of late-stage study (STAT)
  • Updated: Exscientia CEO brought down by allegations of inappropriate employee relationships, in blow to AI pioneer (Endpoints)
  • Organon shelves contraceptive with 'natural' estrogen (Endpoints)
  • Amgen doubles down on ‘bad’ cholesterol awareness with new campaign, free testing (Endpoints)
  • Roivant discontinues blood cancer program as it fails to revive old Eisai drug, to dissolve Hemavant (Endpoints)
  • BMS, VantAI team up; CRISPR Therapeutics to raise $280M; Ono Pharma's deal with Shattuck Labs (Endpoints)
  • EyeBio targets registrational trial after early success of Wnt agonist in retinal diseases (Endpoints)
  • Lingering Leqembi Question: When Should Treatment Stop? (Pink Sheet)
Medtech
  • FDA Says PCCPs Are Possibility For Sterilization Changes (MedTech Insight)
  • FDA AdCom Will Scrutinize Placebo Benefit Of Abbott’s TriClip G4 TTVR (MedTech Insight)
  • eXeX Claims ‘World First’: Apple’s Mixed-Reality Headset Deployed As Logistics Tool In OR (MedTech Insight)
Government, Regulatory & Legal
  • No one’s pleased with the government’s pitch for 2025 Medicare Advantage rates (STAT)
  • Has Oscar finally figured out its health insurance business? (Endpoints)
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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