Recon: Pfizer says COVID vaccine is 90.7% effective in children 5-11; Oncopeptides pulls Pepaxto after failing confirmatory trial

| 22 October 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Walgreens U.S. stores start administering Moderna, J&J COVID-19 booster (Reuters)
  • Americans can mix and match COVID-19 boosters but original vaccine recommended -Fauci (Reuters)
  • C.D.C. Recommends Covid Booster Shots for Millions of Americans (NYTimes) (STAT)
  • Pfizer/BioNTech COVID-19 vaccine shows 90.7% efficacy in trial in children (Reuters)
  • Oncopeptides stock craters as it pulls cancer drug Pepaxto from the market (Endpoints)
  • The four senators who could make or break Democrats’ drug pricing ambitions (STAT)
  • Bat Research Group Failed to Submit Virus Studies Promptly, NIH Says (NYTimes)
  • U.S. Warns of Efforts by China to Collect Genetic Data (NYTimes)
In Focus: International
  • Norway opts not to give 12-15 year-olds second vaccine doses yet (Reuters)
  • Illumina will launch Grail’s cancer detection test in Africa and Asia — but doesn’t know when (STAT)
  • Novartis has negotiated Zolgensma access for half of the European SMA population, exec says. How'd it get there? (Fierce)
Coronavirus Pandemic
  • Delta 'Plus' Covid variant may be more transmissible (BBC)
  • Covid-19 roundup: White House pushes for IP waiver support to WTO; Rare nerve disorder listed as AstraZeneca side effect in UK (Endpoints)
Pharma & Biotech
  • Sanofi, Regeneron etch out another PhIII victory for Dupixent, easing severe itch and clearing lesions (Endpoints)
  • Following August meltdown, Zymergen hints at salvage plans — cutting jobs and renegotiating loans (Endpoints)
  • A new Treg player emerges with $46M and backing from Takeda (Endpoints)
  • Xilio Therapeutics goes public as biopharma IPOs rumble forward in Q4 (Endpoints)
  • Former MIT scientist David Sabatini fires back at accuser, Whitehead Institute for 'false' harassment allegations (Endpoints)
  • Agenus calls out FDA for playing favorites with Merck, pulls cervical cancer BLA at agency's request (Endpoints) (BioPharmaDive )
  • Dupixent hits all endpoints in prurigo nodularis trial (PharmaTimes)
  • Servier Phase III colorectal cancer trial fails to meet primary endpoint (Fierce)
  • Sweden Tackles Regulatory Barriers To Decentralized Trials (Pink Sheet)
  • Metacrine shares halved as NASH program nixed on mixed bag data and early safety issue (Fierce)
  • Hearing aids: incumbents have a sound basis to withstand disruption (FT)
  • Ocular Therapeutix hammered by a PhII failure in dry eye disease — shares tank (Endpoints)
  • FDA Panel Recommends Against Approval Of Integra Mesh For Breast Reconstruction (MedtechInsight)
  • Luminopia scores FDA De Novo for VR treatment for lazy eye (Mobihealthnews)
Government, Regulatory & Legal
  • Lilly breached a contract by not paying royalties on big-selling diabetes meds, court finds (Fierce)
  • Apotex Backs Teva's En Banc Bid In Skinny Label Fight (Law360)
  • Hill-Rom, Baxter Get FTC Warning Letters For $12.4B Deal (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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