Recon: Moderna submits BLA for COVID vaccine; FDA approves Alkermes’ schizophrenia drug

• Supreme Court rebuffs J&J appeal over $2 billion baby powder judgment (Reuters)
• Moderna files for full US approval of COVID-19 vaccine (Reuters) (NYTimes)
• Alkermes schizophrenia drug gets FDA approval (Reuters) (Endpoints)
• BridgeBio keeps FDA approval spree rolling, this time with nod for targeted bile duct cancer med (Fierce)
• US agency says employers can mandate COVID-19 vaccination (Reuters)
• Biden HHS seeks to dismiss PhRMA’s lawsuit to stop Canadian drug imports (Endpoints) (The Hill)
• Biden Administration Signals It’s in No Rush to Allow Canadian Drug Imports (KHN)
• A Glut of Chinese Masks Is Driving US Companies Out of Business (NYTimes)
• New attention on abortion pill dispensing amid challenge to Roe v. Wade (Politico)
• FDA hands a CRL to drugmaker Eton after a delayed inspection — but are Covid-19 travel restrictions really the issue? (Endpoints)

• EU to decide on Astrazeneca's $39 bln Alexion deal by July 5 (Reuters)
• Novartis signs deal that could lead to acquisition of Zurich start-up Cellerys (Reuters) (Fierce)
• EMA logs more clotting cases after AstraZeneca shot, death rate lower (Reuters)
• No change to India's two-dose schedule for AstraZeneca vaccine - govt adviser (Reuters)
• ‘Time has come’ for pandemic treaty as part of bold reforms - WHO’s Tedros (Reuters)
• South Korea's Samsung Biologics to add mRNA vaccine production line (Reuters)
• Sinopharm's Wuhan affiliate boosts COVID-19 shot annual capacity to 1 bln doses (Reuters)
• Russia pauses approval of combined AstraZeneca/Sputnik V vaccine trial, requests data (Reuters)
• Additional manufacturing capacity for BioNTech/Pfizer’s COVID-19 vaccine (EMA)
• WHO grants emergency use authorization for Sinovac coronavirus vaccine (The Hill)

• Covid-19 vaccines burnt as shelf-life complicates global rollout (FT)
• Even after U.S. shift, opponents resist COVID-19 vaccine patent waiver (Reuters)
• Consider global shortages before giving COVID-19 shots to teens, EU body says (Reuters)
• EU says reduction in J&J vaccine deliveries only temporary (Reuters)
• India's Biological E. to make Providence Therapeutics' mRNA COVID-19 vaccine (Reuters)
• India's Dr. Reddy's in talks with government to bring Russia's Sputnik Light COVID-19 vaccine (Reuters)
• India's Serum Institute to raise AstraZeneca COVID-19 vaccine output in June (Reuters)
• Eli Lilly India gets nod for emergency use of antibody drugs combination for COVID-19 (Economic Times)
• South Korea says J&J's COVID-19 shots fully taken up (Reuters)
• Health Canada extends shelf life of some AstraZeneca COVID-19 shots (Reuters)
• Denmark to reconsider exclusion of J&J and AstraZeneca shots (Reuters)
• IFC and development groups to help fund vaccine production in Africa (Reuters)

• Five more biotechs file their SEC paperwork as the IPO Class of 2021 swells to 60 (Endpoints)
• Gene editing biotech Verve indicates a swift swerve onto Wall Street, asking for $100M IPO (Fierce)
• Unapproved Cell/Tissue Product Enforcement Discretion Ends; How Hard Will US FDA Crack Down? (Pink Sheet)
• US FDA’s Remote Evaluations Of Drug Manufacturing Facilities May Become Public (Pink Sheet)
• Companies Take Their Products To GB Market Post-Brexit (Pink Sheet)
• FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug (Pharmafile)
• Sanofi halts venglustat clinical programme in ADPKD (PharmaTimes)
• EC authorises Diurnal’s Efmody for CAH (PharmaTimes)
• Novo Nordisk partners with Heartseed on heart failure cell therapy (PMLive)
• First NHS patient treated with Novartis’ SMA gene therapy Zolgensma (PMLive)
• As plan for new U.S. health agency to speed treatments takes shape, doubts remain (Science)
• FDA’s Oncology Center of Excellence Launches National Black Family Cancer Awareness Week (FDA)
• Sanofi and Merck's first and only six-in-one pediatric combination vaccine now available in the United States (Press)
• Amgen beefs up its late-stage pipeline with a $400M cash deal to go up against heavyweight rivals in a PhIII atopic dermatitis showdown (Endpoints) (Press)
• Mirati wins over a Chinese partner for KRAS hopeful, looking to tail Amgen's breakthrough win (Endpoints)
• Clinical studies for AB Science's all-purpose anti-inflammatory drug grind to a halt as company flags potential risk of heart disease (Endpoints)
• FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma (FDA)
• Recursion CSO heads west for mini-brain upstart; Novartis vet steps up to the plate as CFO for Andrew Hirsch at C4 Therapeutics (Endpoints)
• Exclusive: Helsinn chief Riccardo Braglia spells out a blockbuster plan to take the family pharma public — with an eye on new cancer drug deals, spinout (Endpoints)
• Sanofi slashes another program for key molecule, while keeping hopes in handful of rare diseases (Endpoints)
• Novartis scraps a slate of Beovu trials after 4-week dosing turned up safety issues — dashing hopes of dethroning Eylea (Endpoints)

• Abbott cuts 2021 outlook, blaming rapid decline in COVID-19 testing demand (MedtechDive)              
• ‘We Were A Victim’: How An FDA Remote Regulatory Assessment Took One Device Maker By Surprise (MedtechInsight)
• Brain-computer interface allowing 'locked-in' ALS patients to communicate earns European approval (Fierce)
• Lucida Medical nets CE mark for prostate cancer-detecting AI software (Fierce)
• Advanced Human Imaging's smartphone-based derma AI gets CE mark (MobiHealthNews)
• Acutus Builds On Arrhythmia Mapping Success With New Ablation Devices (MedtechInsight)
• Singapore Consults On Medtech UDI System (MedtechInisght)

• Eli Lilly Gets More Time To Respond To HHS Letter (Law360)
• Key Opioid Trials To Watch As Cases Heat Up Nationwide (Law360)
• 10X Infringes Bio-Rad Patents, Federal Circuit Affirms (Law360)