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August 24, 2023
by Jason Scott

Recon: CVS launches biosimilar subsidiary Cordavis; White House set to identify initial 10 drugs for Medicare negotiations

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Mid-year drug price hikes are back despite Inflation Reduction Act (STAT)
  • White House to name first 10 drugs for Medicare negotiations early (Politico)
  • US FDA taps EPA veteran James Jones to oversee food division after formula crisis (Reuters) (FDA)
  • Mallinckrodt Lenders to Take Control in Bankruptcy That Cuts $1 Billion in Opioid Payments (The Wall Street Journal)
  • Drug makers already bet big on mRNA for cancer. Why is Biden going in, too? (STAT) (Endpoints)
  • A move to cut drug prices has patients with rare diseases worried (CBS News)
  • CVS launches unit to market and co-produce biosimilar medicines (Reuters)
  • Cigna removes pre-authorization requirement for 25% of medical services (Reuters)
  • FDA advisory committee will meet next month to discuss Intarcia's diabetes drug (Endpoints)
  • US FDA’s New Regulatory Affairs Head Should Be ‘Highly Technically Competent’ But ‘Splendid On The Human Side,’ Califf Says (Pink Sheet)
In Focus: International
  • UK pumps £13M into wide-ranging group of manufacturing projects (Fierce Pharma)
  • High demand, low supplies for Novo's weight-loss drug launch in Germany (Reuters)
  • Indian Immunologicals targets dengue vaccine launch by Jan 2026 (Reuters)
  • J&J Cuts R&D at Netherlands Infectious Disease, Vaccine Unit (BioSpace)
  • Amryt’s Filsuvez Wins English Funding For Butterfly Skin Disease, Sanofi’s Dupixent Rejected In New Indication (Pink Sheet)
  • Australian HTA Review: Sponsors Attack Use Of Cheap Comparators, Want More Streamlined Procedures (Pink Sheet)
  • Three Remain Liable On UK Liothyronine Price Abuse – But Fines Slimmed On Appeal (Pink Sheet)
  • UK Aims To Identify Gaps In Current Landscape For Patient Involvement In Trial Design (Pink Sheet)
Pharma & Biotech
  • What past blockbusters can tell us about future of Wegovy and other weight loss medicines (STAT)
  • The Last Lyme Shot Failed. Can a New One Succeed? (Bloomberg)
  • AbbVie drops two early-stage ADCs, including Pfizer-partnered oncology program (Endpoints)
  • KRAS latecomer Roche draws cautious comparisons to Amgen, Mirati in early data (Endpoints)
  • Royalty Pharma pays Ferring $300M for 5% royalty on sales of cancer gene therapy Adstiladrin (Endpoints)
  • SPAC merger falls through between Wilbur Ross' blank check company and Alzheimer's player (Endpoints)
  • In PhIII data, Eli Lilly’s Retevmo meets primary endpoint of improving progression-free survival (Endpoints)
  • Bristol Myers touts early social and environmental progress among achievements in latest ESG report (Endpoints)
  • After high-profile snub, Akebia plots vadadustat resubmission at FDA (Fierce Pharma)
  • Cellares unveils $255M investment round with Bristol Myers among those in the fold (Fierce Pharma)
  • Horizon pips Roche to rare disease reputation crown as Pfizer falls off the leaderboard (Fierce Pharma)
  • Nestle Health Science nabs Meta, Pfizer veteran for chief marketing role (Fierce Pharma)
  • Gilead shows how $100M COMPASS Initiative is changing direction of the HIV epidemic (Fierce Pharma)
  • Geron’s Imetelstat Headed To US FDA Advisory Committee For MDS (Pink Sheet)
  • US FDA’s External Controls Guidance Should Include Hybrid Designs, Experts Say (Pink Sheet)
Medtech
  • FDA panel votes against high blood pressure device from Medtronic, but lends support to ReCor Medical’s (STAT) (Reuters)
  • Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development (FDA Law Blog)
Government, Regulatory & Legal
  • Vivek Ramaswamy’s brashness made waves in the Republican debate. He did the same in biotech (STAT)
  • Ron DeSantis wants to import drugs from Canada. Biden’s FDA just blasted his plan (STAT)
  • Abortion policy in the spotlight, DeSantis’ importation showdown, and new price hike analysis (STAT)
  • US says stolen COVID relief funds seized so far top $1.4 billion (Reuters)
  • GSK asks US patent office to refuse Moderna’s ‘Covid Mvax’ trademark registration as 'too generic' (Endpoints)
FDA Names First Deputy Commissioner for Proposed, Unified Human Foods Program 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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