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Regulatory Focus™ > News Articles > 2022 > 5 > Recon: Moderna completes EUA submission for younger kids and adolescents; Generic firms to cap price

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

Posted 12 May 2022 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
 
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