Regulatory Focus™ > News Articles > 2021 > 10 > Recon: Merck seeks US authorization for COVID drug; EMA reviewing Regeneron, Roche COVID antibody

Recon: Merck seeks US authorization for COVID drug; EMA reviewing Regeneron, Roche COVID antibody

Posted 11 October 2021 | By Michael Mezher 

Recon: Merck seeks US authorization for COVID drug; EMA reviewing Regeneron, Roche COVID antibody

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Merck seeks first U.S. authorization for COVID-19 pill (Reuters)
  • Roche says Alzheimer's therapy gets U.S. breakthrough designation (Reuters)
  • U.S. CDC advisers to review Moderna, J&J COVID-19 booster shots this month (Reuters)
  • Govt to control distribution of GSK/Vir COVID-19 antibody in U.S. – FDA (Reuters)
  • Adamas, Flexion sell for $825M combined as dealmaking pace picks up (BioPharmaDive) (Endpoints)
  • Democrats weigh changes to drug pricing measure to win over moderates (The Hill)
  • CDC sets panel meetings for J&J, Moderna boosters, child vaccines (The Hill)
  • After three decades and a surprise rejection, first treatment for babies born without a thymus secures FDA approval (Endpoints) (FDA)
  • As Biden's vaccinate-or-test mandate approaches, questions arise over enforcement (NBC)
  • Inside the Courtroom With Theranos’s Elizabeth Holmes (NYTimes)
In Focus: International
  • New Ebola case confirmed in eastern Congo (Reuters)
  • Japan's Chugai files to expand use of COVID-19 antibody drug (Reuters)
  • EU assesses Regeneron/Roche COVID-19 antibody cocktail for authorisation (Reuters) (EMA)
  • AstraZeneca antibody cocktail study shows success treating COVID-19 (Reuters) (FT)
  • African Medicines Agency To Be Established In 2022 (Pink Sheet)
  • A global fight looms over Kratom, a possible opioid alternative (Politico)
Coronavirus Pandemic
  • Moderna, Racing for Profits, Keeps Covid Vaccine Out of Reach of Poor (NYTimes)
  • U.S. will accept WHO-approved COVID-19 vaccines for international visitors (Reuters)
  • Lumen lands another DoD contract to treat Covid-related GI issues (Endpoints)
Pharma & Biotech
  • Supernus bolsters Parkinson's portfolio with $400 mln deal for Adamas Pharma (Reuters)
  • The Drug-Dosing Conundrum in Oncology — When Less Is More (NEJM)
  • Researchers find a higher than expected risk of myocarditis in young men after full vaccination. (NYTimes)
  • Mouse experiments with a decades-old drug suggest a new approach to Alzheimer’s treatment (STAT)
  • Searching for the next 'big hairy goal,' BlueRock CEO Emile Nuwaysir jumps to in vivo cell therapy startup Ensoma (Endpoints)
  • In quick turnaround, FDA lifts full clinical hold on Protagonist's blood cancer program (Endpoints)
  • Post-split GSK to exit marquee world HQ, blueprinting smaller corporate digs (Endpoints)
  • Sandoz completes acquisition of GSK’s cephalosporin business (PMLive)
  • Ipsen poaches Novartis vet Mari Scheiffele to serve as president of its international specialty care team (Fierce)
  • Some Dana-Farber Cancer Institute trustees stood to profit from their philanthropic role (STAT) (Endpoints)
  • NICE approves treatment for rheumatoid arthritis (Pharmafile)
  • Idorsia's Fabry disease program flops a PhIII study, leaving its future unclear (Endpoints)
  • 5 health tech startups working to address chronic pain without opioids (STAT)
  • What Does ‘Digital’ Mean For FDA’s Device Center? (MedtechInsight)
  • 4 takeaways from a bumper year of M&A medtech activity (so far) (MedtechDive)
  • Medtronic's surgical robot Hugo gains CE mark, setting up Intuitive faceoff (MedtechDive)
  • Two New Modules Added To Eudamed For Use On Voluntary Basis (MedtechInsight)
  • Mount Sinai unveils first-of-its-kind department to develop AI tools for healthcare (Fierce)
  • Veracyte kicks off limited release of its nasal swab lung cancer test, as it gears up for full commercial launch (Fierce)
Government, Regulatory & Legal
  • AbbVie's Botox patent lawsuit is 'very unlikely to derail' Revance's rival launch: analysts (Fierce)
  • New Trial Sought In CR Bard Hernia Mesh Bellwether (Law360)
  • Canadian Creditors Seek Direct Appeal Of Purdue Ch. 11 Plan (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.


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.