Recon: Moderna completes EUA submission for younger kids and adolescents; Generic firms to cap price of Paxlovid copies at $25 in low-income countries

• Biden marks 1 million Americans dead from COVID (Reuters)
• Moderna completes FDA submission for use of COVID shot in adolescents, kids (Reuters)
• Moderna Vaccine Provokes Strong Immune Response in Children 6 to 11 (NYTimes)
• Lawmakers wade into a contentious battle over orphan drug monopolies (STAT)
• Is Paxlovid, the Covid pill, reaching those who most need it? The government won’t say (Endpoints)
• FDA’s Overview of Catalyst Pharms., Inc. v. Becerra (FDA)
• F.D.A. Authorizes Underwear to Protect Against S.T.I.s During Oral Sex (NYTimes)

• U.S. will share COVID-19 vaccine technology, Biden tells global summit (Reuters)
• COVID-19 deaths cross 2 million mark in the European region – WHO (Reuters)
• Generic drugmakers to sell Pfizer's Paxlovid for $25 or less in low-income countries (Reuters)
• Roche says cancer setback to be cushioned by other drug development (Reuters)
• We will learn from plight of Aspen's COVID vaccine plant – WHO (Reuters)
• North Korea reports its first Covid outbreak. (NYTimes)

• How Far Do You Go When the Alternative Is Death? (NYTimes)
• A Caribou CAR-T treatment, backed by Nobel-winning science, shows blood-cancer remissions in first data reveal (STAT)
• In radical claim, study suggests inflammation wards off chronic pain instead of causing it (STAT)
• Police reports detailing Seagen CEO’s arrest raise questions about biotech’s response (STAT)
• Brigham and Women's gets FDA warning letter after PET operation violations (Endpoints)
• From Our Perspective: FDA’s Role in Helping a Critical Medical Isotope Meet Sufficient Supply in the US for First Time (FDA)
• As controversy swirls around Canadian drug imports, FDA debars doctor for purchasing cancer meds across the border (Endpoints)
• A week after disclosing layoffs, BridgeBio nets a $90M upfront cancer R&D pact with Bristol Myers (Endpoints) (BioPharmaDive)
• Hundreds of patient data breaches are left unpunished (BMJ)
• Taiho, chasing larger rivals, buys back rights to Cullinan cancer drug (BioPharmaDive)
• Ready to go to FDA, can Hengrui's China-made PD-1 liver cancer immunotherapy change the tides? (Fierce)
• Rinvoq passes PhIII maintenance study for Crohn's disease, potentially setting the stage for label expansion (Endpoints)
• Bristol Myers builds the case for psoriasis hopeful as it waits in regulatory limbo (Endpoints)
• Ahead of second FDA chance, CorMedix winds down European business (Endpoints)
• Cullinan Oncology goes full circle, scoring $275M for sharing the load on EGFR inhibitor with original developer (Endpoints)
• Sana's Terry Fry leads new $200M cell and gene therapy institute at University of Colorado (Endpoints)

• The FDA eased rules for mental health apps during the pandemic. Now companies are bracing for it to tighten the reins (STAT)
• Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market (MedtechDive)
• House subcommittee debates device remanufacturing definition, sends user-fees bill to next stage (MedtechDive)
• Device/Drug Borderline: Gray Areas Remain Despite New EU Guidance (MedtechInsight)
• Work Presses On To Harmonize Global Expectations On Using Modeling & Simulation (MedtechInsight)

• CSL's $11.7B Vifor buy, 2021's biggest biopharma M&A deal, hits antitrust delay (Fierce)
• Not so fast on Johnson & Johnson's Texas Two-Step strategy as appeals court says it'll take another look (Fierce)