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

• 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)

• 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)

• 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)

• 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)

• Virtual FDA-Industry MDUFA Negotiations To Kick Off After Months Of Delay (MedtechInsight)

• 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)