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August 15, 2023
by Jason Scott

Recon: Pharma incensed by EU’s compulsory licensing proposal; FDA removes partial hold on Arcellx’s blood cancer drug

In Focus: US
  • DOJ blasts industry attempt to delay Medicare drug price negotiations (The Hill)
  • 'Making it as simple as possible' Amazon Pharmacy offers insulin discounts amid price hikes (USA Today) (Reuters)
  • As COVID-19 vaccine makers gear up to launch updated shots in the private market, can the new vaccines keep up with the virus? (Fierce Pharma)
  • Persistence pays for Delcath as cancer treatment Hepzato Kit finally scores FDA nod (Fierce Pharma)
  • FDA lifts partial hold on Arcellx’s Gilead-partnered blood cancer cell therapy as biotech aims for 2026 launch (Endpoints)
  • Gilead ties up with Tentarix for cancer, inflammatory disease therapies (Reuters)
  • Sandoz says its biosimilar matches Eylea in another threat to Regeneron's blockbuster (Fierce Pharma)
  • Revance touts first therapeutic indication for Botox rival Daxxify in cervical dystonia (Endpoints)
In Focus: International
  • Pharma incensed by EU's compulsory licensing proposal (Pharmaphorum)
  • Rule mandating doctors to prescribe generics may hit patient safety: IMA (Economic Times)
  • UK's ITV invests in pain relief brand Flarin (Reuters)
Pharma & Biotech
  • Catalent, facing pressure from Elliott, had other activists in stock (Reuters)
  • Galecto scraps lung disease treatment after trial failure, shares tank (Reuters)
  • How Biogen outbid a rival 'large-cap' pharma to claim Reata for $7.3B (Fierce Pharma)
  • As former biotech leader Vivek Ramaswamy jumps in the presidential polls, what does he say for the life sciences brand? (Fierce Pharma)
  • Obesity, diabetes drugs push Novo Nordisk and Eli Lilly to front of pharma's growth pack in Q2 (Fierce Pharma)
  • Exclusive: CSO George Yancopoulos talks Regeneron’s next chapter of genetics, weight loss drugs, and Alzheimer's (Endpoints)
  • Following injection side effects, Design Therapeutics to reformulate Friedreich's ataxia drug, delay trial timeline (Endpoints)
  • Takeda spinout HilleVax delays PhIIb norovirus topline data until mid-2024 over processing logistics (Endpoints)
  • YouTube cracks down on misinformation on cancer treatment (STAT)
  • From drug shortages to high prices, U.S. system’s shortcomings have deep roots (STAT)
  • BMS, looking to build a market for a heart drug, turns to a Viz.ai algorithm to detect disease (STAT)
  • Harmony Makes Rare Disease Play with Potential $200M Zynerba Buyout (BioSpace)
Medtech
  • Insulet claims EOFlow copied patch-pump design in patents (MedTech Dive)
  • Medtronic’s bid to dismiss heart device kickback claims fails, clearing case to advance (MedTech Dive)
  • Cue Health wins $28M BARDA contract to develop rapid respiratory infection test (MedTech Dive)
Government, Regulatory & Legal
  • Opioid Settlement Money Is Being Spent on Police Cars and Overtime (The New York Times)
  • Enforcement Trends: CDER Presentation Confirms Fewer Warning Letters Are Issued by FDA for OAI Inspections (FDA Law Blog)
  • SEC wants to know if key supplier of research monkeys bribed foreign officials (STAT)
  • The best way for the NIH to reduce drug prices is to address drug spending (STAT)
 
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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