Recon: J&J delays rollout of vaccine in Europe on news of US pause; India fast tracks emergency approvals of foreign COVID vaccines

ReconRecon | 13 April 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US pauses J&J COVID-19 vaccine over rare blood clots (Reuters) (Focus) (Politico) (NYTimes) (FDA)
  • White House: Johnson & Johnson pause won't have 'significant impact' on vaccination plans (The Hill)
  • Reaction after US recommends pause for J&J COVID-19 vaccine (Reuters)
  • AstraZeneca shot is good if safety issues can be overcome, US official Fauci says (Reuters)
  • FDA lifts curbs on dispensing abortion pills during pandemic (Politico)
  • Novavax says supply shortages delaying full-speed production of its COVID-19 vaccine (Reuters)
  • More therapeutics but no surge in vaccine for Michigan, Biden administration says (Reuters)
  • Federal agency says pharma should pay higher Medicaid rebates if certain trials aren’t finished on time (STAT)
In Focus: International
  • J&J says delaying rollout of COVID-19 vaccine in Europe (FT) (Reuters)
  • India fast-tracks emergency approvals for foreign-produced COVID-19 vaccines (Reuters)
  • India, big vaccine exporter, now seeks imports as COVID cases soar (Reuters 1, 2, 3)
  • India approves Russia's Sputnik V COVID-19 vaccine (Reuters 1, 2)
  • Cipla doubles remdesivir production to meet 'unprecedented' demand (Reuters)
  • China's mRNA COVID-19 vaccine may start late-stage trial in May: state media (Reuters)
  • Europe tries to lower drug prices with small doses of transparency (STAT)
Coronavirus Pandemic
  • Gilead to stop late-stage study of COVID-19 treatment (Reuters)
  • Africa must expand vaccine production, leaders say (Reuters)
  • Spain to vaccinate 70-79 year olds with J&J's one-dose COVID-19 shot (Reuters)
  • WHO, agencies urge countries to suspend sale of live wild mammals at markets (Reuters)
  • Second vaccine dose can be delayed, research says - Italy's AIFA head to paper (Reuters)
  • England to start using Moderna jab on Tuesday (Reuters)
  • Mexico seeks to have own coronavirus vaccine by year-end (FT)
Pharma & Biotech
  • PhRMA’s new message to Washington: Don’t take us for granted (STAT)
  • Huntington’s community grieves not just one therapeutic setback, but two (STAT)
  • Nvidia forges trio of AI-based drug discovery partnerships with AstraZeneca, Schrödinger, University of Florida (Fierce)
  • Jazz Pharmaceuticals pushes to expand label on Xywav; FDA eyes October for decision on Seagen's latest ADC (Endpoints)
    The hunt for a hep B cure heats up, as Antios Therapeutics preps for an IPO (Endpoints)
  • Synthetic Opioids:
  • Considerations for the Class-Wide Scheduling of Fentanyl-Related Substances (GAO)
  • Amarin CEO John Thero passes baton to Europe commercial chief as M&A hopes continue to deflate (Endpoints)
  • Investors throw $189M at Flagship startup's mission to 'decode' interactions between T cells and antigens (Endpoints)
  • Toad venom to treat depression? RA Capital wagers $125M on latest psychedelic biotech (Endpoints)
  • Neil Kumar's BridgeBio finds 7 new academic partners to join the fight against genetic disease (Endpoints)
  • Arcellx raises mega-round to put controllable CAR-T into the clinic (Endpoints)
  • Jaguar, Sean Nolan's latest biotech, raises $139M as they follow Taysha's footsteps (Endpoints)
  • Bain doubles down on Tony Coles’ quest to get a late-stage Parkinson’s drug through to market (Endpoints)
  • Recursion lays out $300M+ goal in IPO terms; Evotec and Bristol Myers team up to spin out German research (Endpoints)
  • Tim Lu’s gene-circuit star Senti signs up for a $645M discovery alliance with Roche sub Spark (Endpoints)
  • OrbiMed-backed Theseus debuts with $100M round in heroic quest for 'pan-variant' kinase inhibitors (Endpoints)
  • Bob Nelsen's Resilience snags Florida CDMO working with the Defense Department on Covid-19 antibody (Endpoints)
  • Eli Lilly, riding pharma's rising digital wave, drafts Apple exec to replace Shah as CDO (Fierce)
  • Accelerated Approval, Real World Evidence Pilot From ICER, Aetion Picks HAE As First Therapeutic Area (Pink Sheet)
  • Tentative Biosimilar Approvals A Consideration for the US FDA (Pink Sheet)
  • iRhythm shares tank after Medicare rates surprise (MedtechDive)
  • MDR date of application next month – and the book (medicaldeviceslegal)
  • FDA clears wireless patient monitoring devices from Masimo, MyHomeDoc (Fierce)
  • Italian test maker DiaSorin puts down $1.8B for Luminex in diagnostics tie-up (Fierce)
  • Doubts cast on CPAP efficacy evidence in HHS agency review (MedtechDive)
Government, Regulatory & Legal
  • Amgen Urges Justices To Leave Enbrel Patent Ruling Alone (Law360)
  • Biden Taps Lowenstein Sandler Atty, Ex-NJ AG To Run DEA (Law360)
  • Pharma Not Immune From Coming Antitrust Wave In China (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.


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