Regulatory Focus™ > News Articles > 2021 > 1 > Recon: EU secures up to 300M more doses of Pfizer-BioNTech vaccine; Sarepta DMD gene therapy fails t

Recon: EU secures up to 300M more doses of Pfizer-BioNTech vaccine; Sarepta DMD gene therapy fails trial

Posted 08 January 2021 | By Michael Mezher 

Recon: EU secures up to 300M more doses of Pfizer-BioNTech vaccine; Sarepta DMD gene therapy fails trial

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Biden to release more available coronavirus doses- spokesman (Reuters) (STAT)
  • Pfizer/BioNTech vaccine appears effective against mutation in new coronavirus variants -study (Reuters) (FT) (STAT)
  • CDC says priority COVID-19 vaccination groups may overlap (Reuters)
  • HHS working to replace potentially faulty Covid tests used by Congress (Politico)
  • When Biden Takes Office, Undoing Trump's Health Policies Won't Be Easy (NPR)
  • ‘What was left for Haven?’: How Amazon’s health ambitions devoured Haven’s plans (STAT)
  • Sarepta gene therapy for DMD stumbles with failed study outcome (STAT) (Endpoints)
  • 2020 brought a huge boom in healthcare investment. How big? SVB analysts have the record-breaking answer (Endpoints)
  • The Next Phase of Vaccination Will Be Even Harder (The Atlantic)
In Focus: International
  • EU says it has secured nearly half of Pfizer's 2021 global output of COVID-19 shots (Reuters) (EC)
  • EU gives go ahead to extract more shots from each Pfizer vaccine vial (Reuters) (EMA)
  • French medical regulator approves Moderna COVID-19 vaccine (Reuters)
  • European watchdog could decide on AstraZeneca vaccine by end-Jan (Reuters)
  • Britain approves Moderna's COVID-19 vaccine, eyes spring rollout (Reuters) (FT) (BBC) (MHRA)
  • Sanofi says could help produce competitors' COVID-19 shots (Reuters)
  • COVID-19 vaccine developed by German research group fails in early trial (Reuters)
  • WHO panel approves delaying time between coronavirus vaccine doses (The Hill)
Coronavirus Pandemic                                                                                                                                                                  
  • WHO has received 13 valid proposals for vaccine emergency listings since October (Reuters)
  • WHO chief says 'clear problem' poorer nations not getting COVID-19 vaccines yet (Reuters)
  • WHO expects to fix dates for China COVID-19 mission 'as soon as next week' (Reuters)
  • Australia enters agreement to buy 51 million doses of Novavax's COVID-19 vaccine (Reuters)
  • Germany secured 50 million vaccine doses from CureVac, BioNTech on top of EU supplies – document (Reuters)
  • EU countries cannot negotiate separate vaccine deals - EU chief (Reuters)
  • German vaccine purchase agreements don’t affect EU contracts – ministry (Reuters)
  • FDA tracks impact of COVID-19 mutations on test performance (MedtechDive)
  • Unblinding Plans For COVID-19 Vaccine Trials Take Roads Less Travelled (Pink Sheet)
  • S.Africa testing vaccines on variant, hopes for results within 2 weeks (Reuters)
  • Brazil CoronaVac producer files for emergency use (Reuters)
  • Brazil snaps up local output of Chinese vaccine for national immunization (Reuters)
  • Mexico to get 400,000-500,000 Pfizer vaccines a week into March, president says (Reuters)
  • Indonesian clerics declare Sinovac's COVID-19 vaccine halal (Reuters)
  • China study says Wuhan COVID infections 3 times higher than official figure (Reuters)
Pharma & Biotech
  • With success in vaccines, scientists try to turn mRNA against autoimmune diseases (STAT)
  • With biotech funding at ‘all-time high,’ Scorpion scoops up $162 million (STAT)
  • Boehringer Ingelheim quietly culls decades-old hypertension med after October recall (Fierce)
  • 5 questions facing gene therapy in 2021 (BioPharmaDive)
  • Celgene's cell therapy spinout nets $292M from blank-check merger (BioPharmaDive)
  • Why 2020 Saw The Steady Rise Of In Silico Trials (Pink Sheet)
  • UK BIA To Push For Post-Brexit Regulatory Agreement With EU (Pink Sheet)
  • US FDA Hiring Metrics Sought To Determine PDUFA VII Changes (Pink Sheet)
  • Monoclonal Antibodies: Developers Explore New Territories (GEN)
  • Seven Biopharma Trends to Watch in 2021 (GEN)
  • Merck KGaA snaps up German CDMO in boost to mRNA portfolio — including for Covid-19 (Endpoints)
  • NICE to reject Bristol Myers' Opdivo in head and neck cancer after 3 years of restricted coverage (Fierce)
  • Shooting the Messenger: Locana Bio Writes a New Script for RNA Diseases (GEN)
  • MHRA review recommends discussion around epilepsy medication and pregnancy (PharmaTimes)
  • FDA sideswipes Neoleukin with clinical hold on lead immunotherapy candidate, sends shares plummeting (Endpoints)
  • Nasdaq rings in its first biotech IPOs of 2021: a CAR-T specialist from China, a cancer portfolio play, and a SPAC (Endpoints)
  • After early hiccups in manufacturing, Adverum outlines plans for commercial gene therapy plant in North Carolina hub (Endpoints)
  • News briefing: Sanofi ponies up more money to expand protein degradation collab with Nurix; Biogen fires shot at Novartis in new Spinraza trial (Endpoints)
  • Watch out, Pfizer: Affinivax lands $226M in funding to advance Prevnar 13 rival as well as the rest of its pipeline (Endpoints)
  • Mana joins the hectic fight against solid tumors with an ‘off-the-shelf’ candidate angling for an IND this year (Endpoints)
  • Chimerix places its bets on Oncoceutics' dopamine antagonist for rare brain cancer in quest to salvage its image (Endpoints)
  • Alkermes promotes from within to find new CFO and COO in rebound effort; Moderna vet Robert Dolski joins Checkmate as CFO (Endpoints)
  • DiCE gets its 'library' card ready as it speeds development of DNA database-derived molecules with more investor cash (Endpoints)
  • IsoPlexis scores big backer for personalized protein 'barcodes' as Perceptive jumps on board new funding round (Endpoints)
Medtech
  • Virtual FDA-Industry MDUFA Negotiations To Kick Off After Months Of Delay (MedtechInsight)
Government, Regulatory & Legal
  • The Long and Winding Road: DEA Issues Final Marijuana Registration Rule (FDA Law Blog)
  • After Lull In Biosimilar IP Litigation, 2021 Could Bring Influx (Law360)
  • NY To Push Back On Efforts To Split Landmark Opioid Trial (Law360)
  • Life Sciences Cos. Increasingly Turn To Arbitration (Law360)
  • 340B Fight: Lilly ‘Disagrees’ With HHS Advisory Stating Discounts To Contract Pharmacies Are Required (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.

Tags: US, worldwide

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