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

• 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)

• 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)

• 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)

• 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)

• As CAR-Ts Proliferate, CMS Seeks To Reserve Medicare Add-On Payments For ‘New’ Therapies (Pink Sheet)