Regulatory Focus™ > News Articles > 2021 > 6 > Recon: Moderna submits BLA for COVID vaccine; FDA approves Alkermes’ schizophrenia drug

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

Posted 01 June 2021 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
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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