Recon: $26B Opioids lawsuit deal imminent; Amylyx closes $135M ALS financing deal

ReconRecon | 20 July 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • How an Unproven Alzheimer’s Drug Got Approved (NYT)
  • States and Cities Near Tentative $26 Billion Deal in Opioids Cases (NYT)
  • Drug distributors settle New York opioid claims for up to $1.18B  (Reuters)
  • Pharma CEOs, lobbyists showered Democrat with cash after his attempt to torpedo Pelosi’s drug pricing bill (STAT)
  • Advocates urge Biden to name patent office director that could transform drug pricing (STAT)
  • FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During Pregnancy (FDA)
  • Ardelyx stock craters as FDA slaps biotech with dreaded ‘deficiencies’ tag on kidney drug (Fierce)
  • Rivus’ fat-trimming therapy nabs $35M to harness our own biology against a host of diseases (Fierce)
In Focus: International
  • GHO Capital Partners doubles its last raise, closing on a massive $2B-plus to advance European healthcare (Endpoints)
  • Bial and Medis to enter partnership on CNS treatments (Pharmafile)
  • Panakès moves into biotech investing with new €150M fund (Fierce)
  • Dutch authorities fine drug maker $23 million for ‘excessive’ pricing of a rare disease drug (STAT)
Coronavirus Pandemic
  • WHO officials say we could have Covid under control next year ‘if we’re really lucky’ (CNBC)
  • Two-thirds of Indians have coronavirus antibodies, survey shows (Reuters)
  • ‘Marketplace’ launched to speed up global access to COVID-19 vaccine (EPR)
  • Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19 (Roche)
  • Vaccine mandates more likely once FDA grants full approvals, health experts say (NBC)
  • Factbox: Countries make COVID-19 vaccines mandatory (Reuters)
  • Unvaccinated say vaccines more dangerous than COVID-19: poll (The Hill)
  • US states are sitting on millions of surplus Covid-19 vaccine doses as expiration dates approach (STAT)
  • Federal judge rules that Indiana University can require Covid vaccines for students (CNBC)
  • Why Do Differences in Clinical Trial Design Make It Hard to Compare COVID-19 Vaccines? (Harvard Law Blog)
Pharma & Biotech
  •  Almirall Focus Firmly On Lebrikizumab After Securing Klisyri Approval (Scrip)
  • Frontier Medicines raises $88M for R&D, including potential rival to Amgen cancer drug (MedCity News)
  • Pacific Biosciences to buy smaller DNA sequencing firm for up to $800 million (STAT)
  • White House contemplates an out-of-D.C. address for new biomedical research agency (STAT)
  • Kineta and Samsung Biologics sign agreement for development and manufacture of anti-VISTA antibody immunotherapy (BioPharma Reporter)
  • Cytokinetics stock soars on heart drug data that sets stage for Phase 3 studies (MedCity News)
  • FDA Is No Longer ‘Getting Crap’ From Sponsors In IND Safety Reports, Temple Says (Pink Sheet)
  • Amylyx closes $135 million financing for late-stage development of ALS drug (Pharmaletter)
  • Keytruda TNBC Approval Now More Likely, But Data Is Bad News For pCR Surrogate Endpoint (Pink Sheet)
  • GentiBio and Forge Biologics Form GMP Manufacturing Partnership (Global Genes)
  • Sean Parker-backed cell therapy startup ArsenalBio plucks Merck VP as new CSO (Endpoints)
  • In an unusual crossover, Gilead hires Arcus CMO Grossman, putting him in charge of cancer pact with his former biotech (Fierce)
  •  Medtech funding surges with early-stage deals (MedTech Dive)
  • After raising $260M, Imperative Care looks to build portfolio of stroke-care companies (MedCity News)
  • Can You Imagine a Pacemaker That Does Its Job, Then Pulls a Houdini? (MD+DI)
  • First US Implant of Carmat's Total Artificial Heart Performed at Duke (MD+DI)
Government, Regulatory & Legal
  • US Trustee Flags Sacklers' Release, Atty Fees In Purdue Plan (Law360) (STAT)
  • Bayer’s BlueRock Therapeutics gains FDA fast track for Parkinson’s disease cell therapy (PMLive)
  • FDA-Nixed Language Can Be In Drug Promos, Expert Testifies (Law360)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.


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