rf-fullcolor.png

 

August 29, 2023
by Jason Scott

Recon: HHS announces first 10 drugs for Medicare price negotiations; Pfizer expects to resume production at Tornado-hit facility in Q4

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
 
In Focus: US
  • Here are the 10 drugs that will be up first for Medicare price negotiation (STAT) (Reuters) (Endpoints)
  • Winners and losers from Medicare’s list of drugs subject to price negotiation (STAT)
  • Explainer: Why the US is negotiating the price of 10 drugs (Reuters)
  • Factbox: Court challenges to Medicare drug price negotiation plan (Reuters)
  • FDA delays enforcement of a pharmaceutical supply chain law to stop counterfeit drugs (STAT)
  • Bristol Myers Squibb's Reblozyl, chasing $4B sales target, wins key FDA label expansion (Fierce Pharma)
  • Roche’s Seven-Minute Tecentriq Jab Wins First Ever Regulatory Approval (Pink Sheet)
  • A 3-Month Delay For A Better Label: US FDA User Fee Goal Extensions Are Usually Good News (Pink Sheet)
  • FDA grants Orphan Drug Designation to Faron’s bexmarilimab in AML (Pharma Times)
In Focus: International
  • NHS sales levy ‘will leave Britain further behind global rivals’ (The Times of London)
  • Japan Sets Luxturna, Other New Prices While Cutting Selected Fast Growers (Pink Sheet)
  • Takeda and ImmunoGen partner to develop and commercialise Elahere in Japan (Pharma Times)
  • Three new UK Approved Bodies to certify medical devices announced by the MHRA (MHRA)
Pharma & Biotech
  • Pfizer could restart production at tornado-hit plant by early Q4 (Reuters)
  • Exclusive: Catalent to explore options after Elliott deal-sources (Reuters)
  • Amgen launches new 'Lower Your LDL Cholesterol Now' campaign backed by the American Heart Association (Fierce Pharma)
  • Arcutis launches branded Zoryve ad for a 'Cream That Can' as it eyes streaming services for new campaign (Fierce Pharma)
  • PacBio, once slated to be acquired by Illumina, is taking on the DNA giant (Endpoints)
  • Celularity signs on to do contract research for Regeneron (Endpoints)
  • Apellis trims staff, shrinks R&D plans to save money in face of looming competition in ophthalmology (Endpoints)
  • Novartis nixes PhII TGFß antibody — and one-time 'wild card' — after benefit-risk assessment (Endpoints)
  • Ginkgo teams up with Google Cloud; Two biotechs raise money through private placements (Endpoints)
  • Lilly’s Cholesterol Pill Shows Early Promise in Phase I Study (BioSpace)
Medtech
  • As competition looms, Insulet sues a rival for allegedly stealing trade secrets on diabetes tech (STAT)
  • ProMED issues ultimatum to striking moderators, as questions about site’s future persist (STAT)
  • Bristol Myers Squibb partners with Cellares for robotic production of pipeline CAR-T drug (Fierce Pharma)
  • OTS Software Guidance Update Underscores Industry Advancements (MedTech Insight)
Government, Regulatory & Legal
  • Pfizer, BioNTech challenge Moderna COVID-19 vaccine patents at US Patent Office (Reuters)
  • Medicare Floats Essential Medicine ‘Buffer Stock’ Incentive For Hospitals (Pink Sheet)
  • Nine Best Practices For Creating And Implementing A Risk Management Plan (MedTech Insight)
  • Hopes dim for Medtronic hypertension treatment after FDA panel rebuff (MedTech Dive)
  • Medtronic identifies patients at increased risk of heart pump failure (MedTech Dive)
  • 3M reaches $6B settlement to resolve combat earplug lawsuits (MedTech Dive)
  • GE HealthCare rolls out software to speed assessment of AFib patients (MedTech Dive)
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.