• TrackersTrackers

    COVID-19 therapeutics tracker

    Almost a year into the pandemic, a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibody bamlanivimab alone and in combination with etesevimab as wel...
  • ReconRecon

    Recon: Canada authorizes J&J COVID vaccine; FDA cautions on fever scanner accuracy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Woodcock Interview on COVID-19 Tests and Vaccines ( NPR ) What to look for in Lilly’s eagerly awaited Alzheimer’s data ( STAT ) Abbott's test to distinguish coronavirus and flu viruses gets US authorization ( Reuters ) FDA approves Roche’s Actemra/RoActemra treatment for rare lung disease ( Pharmafile ) San Diego Zoo apes get an experimental animal vaccine ag...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. More than a dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in ...
  • ReconRecon

    Recon: Amgen buys Five Prime for $1.9B; EU investigating Teva over Copaxone practices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden convenes bipartisan meeting on cancer research ( The Hill ) ( Reuters ) Amgen spends $1.9 billion on Five Prime, eyeing an expansion in Asia ( STAT ) The $14 million CEO: Drug distributor boosts executive’s pay despite historic opioid settlement ( Washington Post ) Pfizer’s Lorbrena scores expanded FDA approval for first-line NSCLC ( PMLive ) ( Endpoints...
  • ReconRecon

    Recon: Merck to conduct new trial of OncoImmune COVID drug; NIH halts convalescent plasma trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says will have enough COVID-19 vaccine for every U.S. adult by May ( Reuters ) ( NYTimes ) Biden calls on states to prioritize vaccinations for teachers ( Reuters ) White House using Defense Production Act to equip Merck plants for J&J vaccine ( Reuters ) ( NPR ) ( Fierce ) White House taps insurers to boost vaccinations among vulnerable communities ( Po...
  • ReconRecon

    Recon: Merck to manufacture J&J COVID vaccine; Merck withdraws Keytruda for third-line SCLC

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck to help make Johnson & Johnson's COVID-19 vaccine: White House official ( Reuters ) ( Politico ) ( WaPo ) J&J COVID-19 vaccine shipping to US, but new deliveries hinge on regulators ( Reuters 1 , 2 ) US downplays possibility of sharing COVID-19 vaccines with Mexico ( Reuters ) Fauci says US must stick to two-shot strategy for Pfizer, Moderna vaccines: p...
  • ReconRecon

    Recon: Merck signs €900M deal for Debiopharm for cancer drug; Perrigo to sell generic business for $1.55B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA authorizes Johnson & Johnson’s single-dose Covid-19 vaccine ( STAT ) ( Reuters ) ( Politico ) ( FDA ) Single-dose Covid vaccine recommended by CDC advisory panel ( Politico ) J&J CEO sees COVID-19 shots in American arms in 1-2 days as shipping starts ( Reuters 1 , 2 ) Johnson & Johnson has planned trials of its vaccine that will include infants ( NYTimes ...
  • ReconRecon

    Recon: FDA approves Sarepta’s third DMD drug; Health Canada authorizes AstraZeneca vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected ( Reuters ) ( STAT ) ( FT ) During COVID-19, FDA’s Vaccine Advisory Committee Has Worked To Boost Public Trust – It Can Still Do More ( Health Affairs ) Sarepta wins new drug approval for patients with Duchenne muscular dystrophy, its third marketed treatment ( STAT ) ( Endp...
  • ReconRecon

    Recon: Merck to buy Pandion Therapeutics for $1.85B; Bahrain authorizes J&J vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democratic opposition could sink Woodcock’s chances to be nominated as permanent FDA commissioner ( BioCentury ) ( Pink Sheet ) ( Endpoints ) Pfizer-BioNTech testing booster of their COVID-19 vaccine in new trial ( Reuters ) ( NBC ) Moderna expects $18.4 billion in COVID-19 vaccine sales in 2021 ( Reuters ) ( FT ) Moderna produces Covid-19 shot targeting varia...
  • Regulatory NewsRegulatory News

    FDA partially rescinds two approvals after orphan exclusivity mix-up

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last week partially rescinded the approval of two supplemental biologics license applications (sBLAs) for recombinant factor IX products after determining that part of the products’ indications were covered by orphan drug exclusivity.   Last year, FDA approved sBLAs for Wyeth Pharmaceuticals’ BeneFIX and Aptevo BioTherapeutics’ Ixinity , granting both products new indicat...
  • ReconRecon

    Recon: Celltrion’s COVID antibody gets EMA rolling review; COVAX delivers first vaccine shipment to Ghana

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA scientists endorse J&J’s Covid vaccine, as new data shed light on efficacy ( STAT ) ( Reuters ) ( NYTimes ) ( Boston Globe ) ( Politico ) CVS Health to administer COVID-19 vaccines in six more states ( Reuters ) Biden to Address Chip Shortages, Supply-Chain Problems With Executive Action ( WSJ ) Novavax Nears Covid-19 Vaccine Game Changer—After Years of Fa...
  • ReconRecon

    Recon: Drugmakers tell Congress vaccine supply to increase in March; Pfizer accused of playing hardball in Latin American vaccine negotiations

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US J&J ready to ship nearly 4 million doses of COVID-19 vaccine in US ( Reuters ) ( Politico ) Pfizer to ship 13M COVID-19 vaccine doses per week to US by mid-March, says executive ( Reuters ) FDA to allow Pfizer-BioNTech vaccine to be stored at standard freezer temps ( Reuters ) ( NYTimes ) Moderna says FDA gave positive feedback on request to increase Covid vac...