Regulatory Focus™ > News Articles > 2021 > 11 > Recon: EMA recommends Regeneron, Celltrion antibodies; Ellume test recall expanded to 2M units

Recon: EMA recommends Regeneron, Celltrion antibodies; Ellume test recall expanded to 2M units

Posted 11 November 2021 | By Michael Mezher 

Recon: EMA recommends Regeneron, Celltrion antibodies; Ellume test recall expanded to 2M units

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Moderna COVID-19 vaccine patent dispute headed to court, U.S. NIH head says (Reuters)
  • Moderna says Covid vaccine has fewer breakthrough cases than Pfizer’s, but higher myocarditis rates in young men (CNBC)
  • The Core Legal Strategy Against Opioid Companies May Be Faltering (NYTimes)
  • Home virus tests recalled over false positives reach 2 million kits. (NYTimes)
  • ‘Quite puzzling’ results in Alzheimer’s study cloud future of tau-targeting antibody treatment (STAT)
  • Mutation Linked to Remdesivir Resistance Found in Covid Patient (Bloomberg)
In Focus: International
  • EU regulator endorses COVID-19 drugs from Regeneron-Roche, Celltrion (Reuters) (EMA)
  • Moderna offers COVID-19 shot at $7 to African Union - Africa CDC head (Reuters)
  • Merck says making progress on meeting surge in lab gear demand (Reuters)
  • Moderna applies for COVID-19 booster shot approval from Japan's health ministry -NHK (Reuters)
  • Hundreds of patients in gene study given rare disease diagnosis (BBC) (STAT)
Coronavirus Pandemic
  • Diabetes problem makes Africa more vulernable to COVID-19 death, says WHO (Reuters)
  • Colorado governor allowing all adults to get vaccine boosters (The Hill)
Pharma & Biotech
  • The importance of persistence in cancer drug development (Nature)
  • Novartis-backed Gamida’s approval plans for cell therapy hits a snag with FDA asking for manufacturing data (Fierce)
  • Baxter CDMO arm to drop $100M to expand fill-finish plant in Germany (Fierce)
  • FibroGen cuts jobs as it weighs anemia drug's future in US (BioPharmaDive)
  • CPhI: As Covid-19 restrictions ease, an inspection backlog could have a big effect on new drugs, generics (Endpoints)
  • Too much iron? Pharmacosmos is betting $225M on a new potential solution for that (Endpoints)
  • Acrivon bags a megaround to advance an old Eli Lilly program, 5 months after launch. Is an IPO far behind? (Endpoints)
  • Vaxxinity, hoping to turn bodies into their own drug factories, makes a subdued Wall Street debut (Fierce)
  • NICE recommends mogamulizumab for treatment of ultra-rare blood cancers (Pharmafile)
  • Organon keeps pedal to the metal, buying up Forendo in 3rd deal since spinning out of Merck (Fierce)
  • List Bio to join Indiana biotech community with $125M CMO investment, 210 new hires (Endpoints)
  • Labelling error leads to retail-level recall of cold and flu medicine (MHRA)
  • Life-saving adrenaline auto-injectors could become available in public places (MHRA)
  • Problems With UK Pharmacovigilance Master Files Top MHRA’s 2021 Inspection Findings (Pink Sheet)
  • UK Industry Warns Against Post-Brexit Regulatory Divergence (Pink Sheet)
Medtech
  • FDA clears heart mapping system that hunts down arrhythmias using only a 12-lead ECG (Fierce)
  • Researchers Find Serious Cybersecurity Vulnerabilities In Siemens Operating System Software: Report (MedtechInsight) (MedtechDive)
  • After another successful quarter, diabetes tech players look ahead to key product launches (MedtechDive)
  • Reclassification of medical devices that are substances introduced into the human body via a body orifice or applied to the skin (TGA)
  • Medical devices reforms: Enhancements to post-market monitoring (TGA)
Government, Regulatory & Legal
  • Elizabeth Holmes case draws closer to end as government says it will rest next week (CNBC)
  • Johnson & Johnson scores 60-day stay in high-profile talc litigation: report (Fierce)
  • Eon, Sandoz Escape Claims Over Generic Heart Drug (Law360)
  • Novartis Beats HHS' Discount-Dodging Claims (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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