Regulatory Focus™ > News Articles > 2021 > 9 > Recon: Pfizer begins Phase 2/3 trial of oral drug for COVID prevention; Biohaven's multiple system a

Recon: Pfizer begins Phase 2/3 trial of oral drug for COVID prevention; Biohaven's multiple system atrophy candidate fails in Phase 3

Posted 27 September 2021 | By Michael Mezher 

Recon: Pfizer begins Phase 2/3 trial of oral drug for COVID prevention; Biohaven's multiple system atrophy candidate fails in Phase 3

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA approves add-on drug for ages 10 & up with rare forms of high cholesterol (FDA)
  • Biohaven's drug candidate for neurological disorder fails study (Reuters)
  • Pfizer begins study of oral drug for prevention of COVID-19 (Reuters)
  • Acceleron Is in Advanced Talks for $11 Billion Sale (Bloomberg) (Endpoints)
  • New ARIA cases dog Biogen's Aduhelm launch in another potential blow to blockbuster hopes — analyst (Endpoints)
  • Google’s provider of at-home Covid-19 tests is now a $3 billion company traded on Nasdaq (CNBC)
  • California AG Announces Appeal Of Purdue Ch. 11 Plan (Law360)
  • States Begin a Complex Booster Shot Rollout for Pfizer Recipients (NYTimes)
  • Biden to receive booster shot today (The Hill)
In Focus: International
  • EMA evaluating data on booster dose of COVID-19 vaccine Spikevax (EMA)
  • S.Korea to vaccinate 12 to 17 year-olds, give boosters to elderly (Reuters)
  • Japan approves GSK's Sotrovimab COVID-19 antibody treatment (Reuters)
  • UK pharmacies in dark about ministers’ plan to maintain drug supplies (The Guardian)
  • EU evaluating data on Moderna's COVID-19 vaccine booster dose (Reuters)
  • Global vaccines project to revamp rules after Britain got more than Botswana (Reuters)
  • Small study shows antibody growth from AstraZeneca, Sputnik Light COVID-19 vaccine mix (Reuters)
  • WHO adds Regeneron drug to recommended Covid-19 treatments, but criticizes its pricing (STAT)
  • Budget cuts hinder efforts to eliminate neglected tropical diseases (FT)
Coronavirus Pandemic
  • COVID-19 pandemic cut life expectancy by most since World War Two –study (Reuters)
  • The coronavirus vaccine that the world forgot could still help save it (Endpoints)
  • WHO looks to revive probe into COVID-19 origins: report (The Hill)
  • Cuba kicks off COVID-19 vaccine exports with shipment to Vietnam (Reuters)
  • Russia, Vietnam reach agreement on Sputnik V supplies -RIA (Reuters)
  • EU Joint Regulatory Assessment Project Bears Fruit In COVID-19 (Pink Sheet)
Pharma & Biotech                                                                                                     
  • In May, 10 moderate Democrats opposed major drug pricing reform. Ahead of a key vote, that list is shrinking (STAT)
  • What is the role of outside advisers to the U.S. FDA and CDC in vaccine decisions? (Reuters)
  • The road to Aduhelm: What one ex-FDA adviser called 'probably the worst drug approval decision in recent US history' for an Alzheimer's treatment (CNN)
  • After pumping the brakes on their Angelman syndrome study, Ultragenyx and GeneTx are back in the race (Endpoints)
  • Pfizer stumbles close to finish line in growth hormone race, extending the lead of rival Ascendis (Fierce)
  • US injectables supplier Hikma acquires Custopharm (Pharmafile)
  • Merck touts a confirmatory Keytruda win for liver cancer as 'dangling' accelerated approval saga marches on (Endpoints)
  • Syndax and Incyte, both reeling from cancer drug setbacks, pen chronic graft-versus-host disease collab (Fierce)
  • USFDA issues six observations after inspection of Biocon's Malaysian arm manufacturing facility (Economic Times)
  • Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency (FDA)
  • Amid pandemic, medtech R&D, merger activity jumped: EY report (MedtechDive)
  • Epic’s sepsis algorithm is going off the rails in the real world. The use of these variables may explain why (STAT)
  • Novo Nordisk to smarten up its disposable insulin pens with digital diabetes devicemaker Biocorp (Fierce)
  • Zebra Medical earns its stripes with FDA nod for AI to catch calcium build-up in arteries (Fierce)
Government, Regulatory & Legal
  • Merck, Pfizer end patent feud over pneumococcal vaccines with royalty-centered settlement (Endpoints)
  • Biogen used charity giving to illegally boost multiple sclerosis drug sales, Humana lawsuit says (Fierce)
  • Novo Nordisk settles insulin pricing suit for $100M (Endpoints)
  • Biogen can't escape copay kickback lawsuits as Humana alleges 'seeding and sweeping' scheme (Endpoints)
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.