Recon: Moderna starts Phase 2 hybrid study aimed at Omicron, FDA steps up use of CRLs for breakthrough drugs

| 10 March 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna Starts Study of Hybrid Vaccine That Targets Omicron (Bloomberg) (Fierce)
  • US FDA’s 2022 Novel Agent Actions Suggest Acceleration In Use Of Complete Response Letters (The Pink Sheet)
  • Selecta back in phase 1 gene therapy saddle after clinical hold lift, plans to reboot ‘expeditiously’ (Fierce)
  • Venatorx hits goal in antibiotic phase 3, clearing path to FDA (Fierce)
  • Intellia’s CRISPR-engineered cell therapy secures FDA orphan drug status after AML trial launch (Fierce)
  • White House warns of ‘severe hit’ to COVID-19 response after funding dropped (The Hill)
  • Medical Research Funding Survives as Democrats Cut Covid Money (Bloomberg)
  • As providers are accused of interfering with access to patient data, pressure builds on government to act (STAT)
In Focus: International
  • UK Should Look To France To Speed Up Access To Innovative Medicines (The Pink Sheet)
  • EU Laws On Medicines Supply To Northern Ireland Move Closer (The Pink Sheet)
  • Hard Decoupling: Foreign Firms Less Optimistic About China But Health Sector Revenues Growing (The Pink Sheet)
  • Shionogi Files Oral COVID Antiviral In Japan, Vaccine Shows Phase III Promise (Scrip)
Coronavirus Pandemic
  • Variant that combines Delta and Omicron identified; dogs sniff out virus with high accuracy (Reuters)
  • Masking helped protect children from the virus last fall, a C.D.C. study suggests (NYT)
  • Covid-19 Cases Falling But Infection Levels Still Remain High (Bloomberg)
Pharma & Biotech
  • Gilead Braces For 114 Job Cuts at Former Immunomedics Facility (BioSpace) (Endpoints)
  • Big Pharma hits pause on trials in Russia, Ukraine as they ramp up humanitarian aid (Endpoints)
  • Roche-partnered Scenic Biotech snags $31M to study 3 rare disease drugs (Fierce)
  • Cybercrime Explodes as Pharma Financial Fraud Challenges Counterfeiting (BioSpace)
  • Morningside rolls up a pair of biotechs to birth clinical-phase inflammatory disease player (Fierce) (BioSpace)
  • Moderna CEO’s Salary Spikes while the Median Employee’s Falls (BioSpace)
  • The offer doesn't stop at Covid. Novartis opens up manufacturing ops to make Carisma’s CAR-M cell therapy (Endpoints)
  • J&J expands deal with little-known Welsh biotech using 3D printing to better encapsulate drugs (Endpoints)
  • How the Biopharma Workforce is Shaping the Future (BioSpace)
  • Aiming to drug genetic modifiers, Roche-partnered biotech bags $31M to fuel a drive toward clinic (Endpoints)
  • Vibalogics adds capacity for virotherapy manufacturing in Germany (BioPharma Reporter)
  • New research casts doubt on a cornerstone of thyroid cancer treatment (STAT)
  • Old Drug Works as Well as Antibiotics Against Urinary Infections (Bloomberg)
  • UK MHRA’s IVD Chief Warns About ‘Wrong’ Deviation From EU Medtech Regulations (MedTech Insight)
  • Omada Health Panel Outlines Transformative Role Of Digital Health In Rural Areas (MedTech Insight)
  • Zimmer Biomet rolls out first AI tool to predict post-op outcomes (Fierce)
Government, Regulatory & Legal
  • After coming out of bankruptcy, Mallinckrodt pays out $260M to settle Acthar Gel lawsuits (Endpoints)
  • Mylan Entities Trimmed From Bausch Trulence Infringement Suit (Bloomberg)
  • Purdue Gets Approval For New $5.5B Ch. 11 Sackler Deal (Law360)
  • Athira Pharma Asks Judge to Toss Investor Suit on CEO’s Research (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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