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Regulatory Focus™ > News Articles > 2021 > 5 > Recon: ASCO 21 updates; Moderna goes for teen EUA

Recon: ASCO 21 updates; Moderna goes for teen EUA

Posted 25 May 2021 | By Kari Oakes 

Recon: ASCO 21 updates; Moderna goes for teen EUA

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization (NYT) (NPR)
  • President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals (Fortune)
  • Bipartisan Legislation Introduced to Advance Biomedical Research Stalled by Pandemic (Global Genes)
  • FBI warns of Conti ransomware attacks targeting U.S. healthcare networks (Healthcare IT News)
  • We aren’t getting a national vaccine ‘passport.’ So let’s use the next best thing: CDC vaccination cards (KFF)
  • Corporations Encourage Employee Vaccination but Stop Short of Mandates (KHN)
  • Better Late Than Never? US FDA’s Oddly Timed COVID Master Protocol Guidance (Pink Sheet)
  • C.D.C. Will Not Investigate Mild Infections in Vaccinated Americans (NYT)
  • CDC identifies only 10,000 COVID-19 infections in fully vaccinated, but likely an undercount (The Hill)
  • New York Covid vaccine rates plummet as states roll out more freebies for shots (CNBC)
  • The lingering threat of fall Covid-19 outbreaks (Vox)
In Focus: International
  • 5 questions ahead of MDR's May 26 go-live date (MedTech Dive)
  • EU infrastructure for COVID certificate ready from June, von der Leyen says (Reuters)
  • EU Commission working on forced vaccine license transfers - Italy's Draghi (Reuters)
  • UK government ‘concerned’ over Elliott Management’s plans for GSK (PMLive)
  • WHO director-general calls for countries to vaccinate at least 10 percent of their populations by September (The Hill)
  • WHO risks paralysis due to funding shortage – Ryan (Reuters)
  • Mexico ramping up COVID-19 trial work tapping Sanofi, China's shots in late-stage tests (Fierce)
  • State Department, CDC warn against travel to Japan ahead of Summer Olympics (NBC)
  • India isn’t the only one. Covid cases are rising at record levels in these places too (CNBC)
  • Poland dangles lottery jackpot to boost COVID vaccination drive (Reuters)
  • Bharat Biotech expects EUA from WHO for Covaxin in July- September (Economic Times)
Coronavirus Pandemic
  • Timeline: How the Wuhan lab-leak theory suddenly became credible (WaPo)
  • U.K. Study Shows Power of Digital Contact Tracing for COVID-19 (NIH Director’s Blog)
  • Op-Ed: The Jury Is Out on COVID Boosters (MPT)
  • Children's Risk Of Serious Illness From COVID-19 Is As Low As It Is For The Flu (NPR)
  • Tocilizumab May Benefit Certain Severe COVID-19 Patients (MPT)
  • Explainer: What is 'black fungus' that is hitting India's COVID-19 patients? (Reuters)
  • How COVID Changed Science (SciAm)
  • Op-Ed: Protect the Patents (MPT)
Pharma & Biotech
  • Biogen's $1B Swiss plant scores regulatory nod as drugmaker awaits pivotal FDA decision on aducanumab (Fierce)
  • Novo Nordisk's Keenly Awaited Semaglutide Trial To ‘Redefine’ Alzheimer’s? (Scrip)
  • 'Rejuvenating' the Alzheimer's brain (Eurekalert)
  • Breakthrough designation for Boehringer’s drug for cognitive impairment associated with schizophrenia (Pharmaletter)
  • Medicare: Cover amyloid PET scans and stop keeping people with dementia in the dark (STAT)
  • Xeris to Acquire Strongbridge (Global Genes)
  • Most Oncology Trials Fail to Report Timely Results (MPT)
  • Pushing the envelope with PCSK9 (Nature)
  • New JV from upstart biotechs Pyxis, Alloy aims for rapid drug development in cancer, autoimmune diseases (Fierce)
  • ADC Therapeutics taps Avid for production of its new blood cancer med Zynlonta (Fierce)
  • Keytruda challenger takes center stage at ASCO 2021 (Pharmaletter)
  • LAG3 beyond BMS at ASCO21: Data Byte (Biocentury)
  • Viral vector crunch as gene therapies, vaccines take off (Pharmaletter)
  • Spurred on by Moderna and Pfizer's success, a Belgian biotech has big ambitions for its self amplifying RNA vaccine play (Endpoints)
  • ‘It’s not a cure’: A gene therapy is opening a new chapter for children, but challenges endure (STAT)
  • Nanoparticle based shot could boost efficacy, accelerate production of seasonal flu vaccines (Biopharma)
  • Will the puzzle pieces ever snap together for CAR-T for solid tumors? (Endpoints)
  • Days after FDA clears C3 drug, Apellis spotlights ex-US PhIII win among patients who haven't taken Soliris (Endpoints)
  • Blackstone draws on four senior advisers’ diverse experiences as deal range continues to expand (Biocentury)
  • Pieris inks respiratory partnership with Genentech, adding another to slate of milestone-heavy deals (Endpoints)
  • Xilio inks Merck deal to run checkpoint inhibitor combo tri (Fierce)
  • EC approves Venclyxto-based combinations for adults with newly diagnosed acute myeloid leukemia (Roche)
  • Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals (PubMed)
  • New research begins on producing HIV treatments in plants (Pharmafile)
  • Racemases: The hunt for drugs to neutralise these critical enzymes (Eurekalert)
  • Hemp Seed Breeders Need Academic Research to Solve Total THC Problem (PR Newswire)
  • FDA clears 2 endoscopes that avoid reprocessing (MedTech Dive)
  • Boston Scientific Recalls Over 30,000 Stent Systems Due to Migration Risk (MD+DI)
  • Medicare created a $30 billion market overnight – now we must get it right (MedCity News)
  • Guardant’s Partnership with Janssen Bears Fruit (MD+DI)
  • Ransomware, other cyber threats mount as medtech industry tries to adapt (MedTech Dive)
  • New Microporous 3D Printing Material Offers A New Kind of Design Freedom (PR Newswire)
  • Call for Abstracts — 2022 Petrie-Flom Center Annual Conference: Diagnosing in the Home (Harvard Law Blog)
  • Why DarioHealth plans to acquire a behavioral health company (MedCity News)
  • ‘Underfunded and undervalued’: Ro’s acquisition of Modern Fertility puts a spotlight on health tech’s gender gap (STAT)
Government & Regulatory
  • DEA Can't Ban Psilocybin Therapy, States Tell 9th Circ. (Law360)
  • Thorny Questions Raised by Lanham Act Claim Better Left to FDA (Drug & Device Law)
  • Hagens Berman Loses Privilege In Thalidomide Sanction Fight (Law360)
  • Eli Lilly Says HHS Trying To Foil Case Over Drug Discounts (Law360)
  • Ariosa, Illumina Resolve DNA Patent Dispute At High Court (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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