Regulatory Focus™ > News Articles > 2021 > 5 > Recon: Pfizer plans COVID vaccine BLA submission this month; Gilead sues Russia over remdesivir comp

Recon: Pfizer plans COVID vaccine BLA submission this month; Gilead sues Russia over remdesivir compulsory license

Posted 04 May 2021 | By Michael Mezher 

Recon: Pfizer plans COVID vaccine BLA submission this month; Gilead sues Russia over remdesivir compulsory license

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month (CNBC)
  • The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. (NYTimes)
  • Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine (NYTimes) (WSJ) (Endpoints) (Reuters)
  • White House to shift COVID-19 vaccine to states with more need (Reuters)
  • House Democrats ramp up pressure on drug prices (Politico)
  • Democrats Disagree About How to Spend Potential Prescription Drug Windfall (KHN)
  • US trade chief Tai says recovery depends on addressing global vaccine inequity (Reuters)
  • A Psychedelic Drug Passes a Big Test for PTSD Treatment (NYTimes) (Endpoints)
  • Novartis Ends Bid to Block Imports of Regeneron’s Eye Syringes (Bloomberg) (Endpoints)
  • Big three drug distributors blame doctors, regulators in trial over opioid epidemic (Reuters)
  • FDA approves expanded use for Chiesi’s sickle cell drug Ferriprox (PMLive)
In Focus: International
  • CureVac says mass vaccine rollout thrown into doubt by US restrictions (Reuters)
  • EU regulator begins real-time review of first Chinese COVID-19 vaccine (Reuters) (EMA)
  • BioNTech nearing request for approval of longer-lasting version of COVID vaccine (Reuters)
  • Denmark drops J&J Covid vaccine over blood clot concerns (FT)
  • Brazil looks to new Pfizer contract to speed up vaccinations (Reuters)
  • Gilead sues Russia over a compulsory license issued to a company making remdesivir (STAT)
  • White House struggle to define its vaccine diplomacy leaves Ukraine hanging (Politico)
  • Pressure Mounts to Lift Patent Protections on Coronavirus Vaccines (NYTimes)
  • European Commission fines a Merck KGaA unit for providing misleading info prior to a merger (STAT)
Coronavirus Pandemic
  • WHO is closely monitoring 10 Covid variants as virus mutates around the world (CNBC)          
  • Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19: Notice (Health Canada)
  • Lilly accelerating baricitinib's availability in India following receipt of permission for restricted emergency use as a COVID-19 therapy via donations and licensing agreements (Press)
  • Lilly plans donation of COVID-19 therapies to Direct Relief for use in low- and lower-middle-income countries (Press)
Pharma & Biotech
  • World’s Pharmaceutical Inspectorates Prepare For Post-Pandemic Remote Site Assessments (Pink Sheet)
  • FDA Avoided Half Of ANDA Pre-Approval Inspections During COVID By Using Alternative Tools (Pink Sheet)
  • US FDA Facility Records Review Evolved Into More Formal Process As Pandemic Continued (Pink Sheet)
  • Janssen seeks EU approval for first CAR-T therapy cilta-cel (PharmaTimes)
  • ENABLE: an engine for European antibacterial drug discovery and development (Nature)
  • Merck lays out vision for women's health spinout Organon, with some special plans for its $9B windfall (Endpoints)
  • Pfizer hits the brakes on their pivotal trial for a BCMA/CD3 bispecific on safety concerns while FDA roadblock is holding up Duchenne MD PhIII (Endpoints)
  • Lilly's Covid-19 partner AbCellera is taking a new antibody into the clinic in the hopes it can tackle all variants (Endpoints)
  • Acella, facing 43 'serious' side effect reports, pulls dozens of lots of sub-potent thyroid drug (Fierce)
  • AZ/Amgen Fail In EU Fast-Track Bid For Tezepelumab (Pink Sheet)
  • NICE finds more SMA patients eligible for £75,000 a vial drug (Pharmafile)
  • ViiV Healthcare initiates rolling submission of new drug application with US FDA for long-acting cabotegravir for prevention of HIV (Press)
  • Josh Bilenker and Jeff Engelman bundle a motherlode of cash for their stealthy startup, attracting a who's who of biotech investors (Endpoints)
  • Can a topical treatment beat blockbuster eye injectables? A Swiss biotech has the cash now to find out (Endpoints)
  • Labcorp to pick up Myriad's Vectra rheumatoid arthritis diagnostic blood test (Fierce)
  • Orthopaedic companies project 'return to normalcy' as electives recover in Q1 (MedtechDive)
  • Personalized electric stimulation for epilepsy, depression? Morningside bets $17.5M on an idea dating back to Roman Empire (Endpoints)
  • Battelle Closes Sites, Asks FDA To Pull Mask Decontamination EUA (MedtechInsight)
  • FDA Announces June Meeting On Orthopedic Device Regulation (MedtechInsight)
  • Consultation open for Swiss ordinance governing IVD products (Emergo)
Government, Regulatory & Legal
  • As CAR-Ts Proliferate, CMS Seeks To Reserve Medicare Add-On Payments For ‘New’ Therapies (Pink Sheet)
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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