Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

• Pfizer-BioNTech files for US approval of COVID-19 vaccine (Reuters) (NYTimes) (Politico) (Press)
• Covid-19 Vaccines Are Wasted as Special Syringes Run Short (WSJ)
• How Big Pharma finds sick users on Facebook (TNW) (Ars)
• Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug (Endpoints)
• The US opened pandora’s box on IP waivers for Covid-19 vaccines. What happens now? (STAT)
• Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales (STAT)
• With no upfront payment or milestones on the line, Nkarta and CRISPR join forces on CAR-NK search (Endpoints) (STAT)

• WHO approves emergency use of China’s Sinopharm Covid vaccine (FT)
• EU executive eyes new Pfizer deal for 1.8 bln COVID vaccines "very soon" (Reuters)
• EU split on vaccine waiver idea, unlikely to take clear stance (Reuters)
• US move to loosen vaccine patents will draw drug companies to bargain (Reuters)
• Pharma Has Limited Legal Options If Vaccine Patents Waived (Bloomberg)
• Merkel rejects US move to waive patents on vaccines (FT) (Reuters)
• France's Macron: vaccine patents not the issue, it's getting jabs out (Reuters)
• Canada says it's ready to discuss COVID-19 vaccine IP waiver (Reuters)
• AZ' Tagrisso first to win MHRA approval under Project Orbis (PharmaTimes) (Pink Sheet) (MHRA)
• International regulators and WHO call for wider public access to clinical data (EMA)

• Baltimore Vaccine Plant’s Troubles Ripple Across 3 Continents (NYTimes)
• This Small Canadian Drugmaker Wants to Make J&J Vaccines for Poor Nations. It Needs More Than a Patent Waiver. (KHN)
• EU reviews reports of rare nerve disorder after AstraZeneca's COVID-19 shot (Reuters) (EMA)
• EU regulator begins real-time review of GSK-Vir COVID-19 antibody drug (Reuters) (Press)
• Unused COVID shots piling up in Japan amid slow rollout (Reuters)
• France delaying EU order for COVID-19 vaccine -Germany's Welt (Reuters)
• Confidence in the safety of the J&J vaccine is low following US pause, Kaiser survey shows (CNBC)
• Britain, Germany in role reversal on AstraZeneca vaccine risks (Reuters)
• UK says under-40s should be offered alternative to AstraZeneca vaccine (Reuters)
• Vietnam reports first death in patient who received AstraZeneca COVID-19 vaccine (Reuters)
• Top CDC official resigns from post following reassignment (Politico)
• Covid Testing Has Turned Into a Financial Windfall for Hospitals and Other Providers (KHN)

• CBER Will Staff Up With 100 More Reviewers ‘By Hook Or By Crook,’ Marks Says (Pink Sheet)
• Catalent snaps up Promethera's cell therapy subsidiary, complete with a Belgian plant to help scale plasmid DNA efforts (Endpoints)
• Galapagos chops into their pipeline, dropping core fields and reorganizing R&D as the BD team hunts for something 'transformative' (Endpoints)
• Two drug makers, two commercial launches — with divergent results (STAT)
• A 'flyover' biotech launches in Texas with four Ron DePinho-founded companies under its belt (Endpoints)
• AstraZeneca caps PD-L1/CTLA-4/chemo combo comeback with OS win. Is tremelimumab finally ready for approval? (Endpoints)
• Hours before expected debut, Gyroscope postpones its IPO as 2 other biotechs hold the line on their march to Nasdaq (Endpoints)
• Amid virtual trial craze, Science 37 earns unicorn status and a trip to Nasdaq on the back of SPAC deal (Endpoints)
• Merck kidney and uterus cancer treatments granted priority review by FDA (Pharmafile)
• Another Moderna expansion is announced, this time at its Massachusetts site (Endpoints)
• Lonza keeps adding on as it looks to beef up biologics offering, tacking on nearly $1B in expansions in EU, US (Endpoints)
• Another failed trial for Orphazyme's 'pipeline-in-a-product' leaves shadow on drug's future (Endpoints)
• Goldman Sachs jumps aboard Bain-backed 503(b) compounding pharmacy with a $275M debt loan to supply hospitals (Endpoints)

• FDA’s Shuren: ‘Senior-Level Folks’ Will Take Part In New Inspectional Affairs Council (MedtechInsight)
• Shuren: Routine premarket review of IVDs will lag for the balance of 2021 (BioWorld)
• After QSR Delays, ‘It’s Full-Steam Ahead With That Proposed Regulation,’ FDA’s Shuren Vows (MedtechInsight)
• How The EU Artificial Intelligence Regulation Will Overlap With Medical Device Regulations (MedtechInsight)
• With MDR nearing, EU updates guidance on transition to Eudamed database (MedtechDive)
• J&J Vision extends cataracts land-grab with U.S., Canada approvals for vision-correcting intraocular lenses (Fierce)
• Viome scores FDA breakthrough label for cancer-screening, microbiome-sequencing AI platform (Fierce)
• iRhythm again meets with Medicare rate setter after cardiac monitoring pay cut by nearly $200 (MedtechDive)
• Quidel says COVID-19 testing 'not forecastable' as it targets alternative, at-home markets (MedtechDive)

• Gillibrand touts legislation to lower drug costs: This idea 'is deeply bipartisan' (The Hill)
• Quest Pharmaceuticals Loses In Opioid Liability Coverage Suit (Law360)
• Clinics' Stem Cell Treatments Endanger Patients, DOJ Says (Law360)
• Generic Drug Cos. Invoke FTC Restitution Limits Against AGs (Law360)