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March 28, 2023
by Joanne S. Eglovitch

Recon: Novartis, Bicycle ink deal valued up to $1.7B to develop targeted radiotherapies; WHO revises COVID-19 vaccine recommendations for Omicron

In Focus: US
  • Vaccine Decisions: US FDA And CDC Weigh New Vaccines For Diseases From Dengue To RSV (Pink Sheet)
  • U.S. FDA panel to discuss Perrigo’s daily OTC birth-control bill in May (Reuters)
  • At Tofersen Panel Review, US FDA Shined A Light On Internal Differences Of Opinion (Pink Sheet)
  • Drug Supply Chain is Vulnerable to Threats, Says Senate Committee (FDAnews)
  • FDA Generics Program Resumes In-Person Meetings (FDAnews)
  • Neonatal Drug Development Could Benefit From Rare Disease Experience (Pink Sheet)
  • Senator asks FTC to investigate AmerisourceBergen over abortion pill distribution plans (Endpoints)
  • As US plots biomanufacturing boost, National Resilience nets $410M loan from Defense Department (Fierce) (Endpoints)
  • How the drug industry uses fear of fentanyl to extract more profit from naloxone (STAT)
 
In Focus: International
  • WHO revises COVID-19 vaccine recommendations for Omicron-era (Reuters) (WHO)
  • Amicus nabs EU nod for Pompe disease newcomer Pombiliti, setting up fight with Sanofi (Fierce)
  • WHO Consults On Updates To 24-Year-Old GMP Requirements For Pharma Excipients (Pink Sheet)
  • Ukraine needs more prosthetics clinicians as war toll mounts (Reuters)
  • Sandoz severs ties with European CMO – Dicillin permanently withdrawn from market  (MedWatch)
Pharma & Biotech
  • Novartis to ride with Bicycle in radiopharmaceuticals deal that could cruise to $1.7B (Fierce) (BioSpace) (Endpoints)
  • BMS re-ups ‘highly productive’ legacy neurodegeneration partnership with Evotec for $50M upfront (Fierce) (BioSpace)
  • Eli Lilly to increase investment to $1B into new Irish manufacturing facility — report (Endpoints)
  • Sonoma takes ‘a big bite’ with $120M Regeneron Treg collab, tacking on up to 5 new targets (Fierce) (BioPharma Dive)
  • Ferring shuts down U.S.-based research institute after more than 25 years, cutting nearly 90 employees (Fierce)
  • Boehringer puts $481M on the line to pursue emerging cancer target in Covant team-up (Fierce)
  • With another wave of layoffs and CEO exit, AMT seek out ‘strategic alternatives’ (Fierce)
  • Merck KGaA takes back control of PD-L1 cancer drug as Pfizer alliance ends (Endpoints)
  • Gunning for 2023 approval, GSK details PhIII data for Jemperli in frontline endometrial cancer (Endpoints)
  • Australian engineers create ‘flexible robot’ for 3D printing inside the body (Reuters)
  • BioNTech readies for plunge in Covid sales, will boost mRNA and oncology pipelines (Endpoints)
  • Gamida Cell makes more staff cuts and restructures as it focuses on potential drug launch (Endpoints)
  • AbbVie drops CytomX partnership, leaving PhII program in the air (Endpoints)
 
Medtech
  • Pivotal Opportunity For UK Medtech Must Not Be Wasted (MedTech Insight)
  • Getinge heart pump has CE mark suspended by second notified body, halting sales for 3 months (MedTech Dive)
  • Wesper Next-Generation Device Cleared for Sleep Test Data Collection (FDAnews)
  • Bill would require Medicare to cover breakthrough devices for four years (MedTech Dive)
  • Mammography AI maker iCad lays off another 28% of workers as losses grow, revenues shrink (Fierce)
  • LSI 2023: What Ophthalmology Start-Ups Pitched To Investors At Emerging Medtech Summit (MedTech Insight)
Government, Regulatory and Legal
  • Supreme Court Seems Ready To Uphold Ruling Against Amgen’s Anti-PCSK9 Antibody Patents (Pink Sheet)
  • Esperion sues Daiichi Sankyo, demanding payment of $300M milestone for cardio drug (Endpoints)
  • California Judge Says Zantac Single-Plaintiff Lawsuit May Proceed (FDAnews)
  • Buyers of Abbott’s Recalled Baby Formula Cite Economic Harm (Bloomberg)
 
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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