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

• 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)

• 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)

• Diabetes problem makes Africa more vulernable to COVID-19 death, says WHO (Reuters)
• Colorado governor allowing all adults to get vaccine boosters (The Hill)

• 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)

• 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)

• 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)