• ReconRecon

    Recon: Trump admin eyes term limits on top health jobs; Pfizer temporarily reduces vaccine shipments

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vaccine reserve was already exhausted when Trum administration vowed to release it ( Washington Post ) Trump admin races to enact term limits for top health scientists ( Politico ) Trump wants billions cut from global Covid vaccine distributor ( Politico ) Former FDA commissioner: "Reliable drug supply is absolutely critical" ( Axios ) Biden taps D.C. veteran...
  • ReconRecon

    Recon: Woodcock expected as acting FDA commissioner; J&J vaccine induces immune response in early trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Woodcock to serve as acting FDA commissioner, Sharfstein a contender for top FDA job ( BioCentury ) ( Endpoints ) ( Bloomberg ) Biden’s Covid board in the dark on final vaccine plan ( Politico ) Data fuel debate over whether J&J’s one-dose Covid vaccine will measure up ( STAT ) ( Bloomberg ) ( NEJM ) J&J vaccine on track for March rollout with target to delive...
  • ReconRecon

    Recon: US buys 1.25M more doses of Regeneron COVID antibody drug; Sinovac defends vaccine after latest Brazilian data

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA fights for independence in Trump administration's final days ( Politico ) Johnson & Johnson Expects Vaccine Results Soon but Lags in Production ( NYTimes ) Supreme Court Revives Abortion-Pill Restriction ( NYTimes ) Operation Warp Speed chief resigns at Biden team’s request, will stay through transition, sources say ( CNBC ) US to buy 1.25M additional dos...
  • ReconRecon

    Recon: US overhauls vaccine rollout plans; Novartis, BeiGene partner on tislelizumab

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US HHS 'unleashed' in string of last-minute policies ( Politico ) In a last-minute, intra-agency scuffle, HHS overrules FDA pick for a key position ( STAT ) ( Politico ) Pfizer has produced more than 70 million COVID-19 vaccine doses: CEO ( Reuters ) US shifts to speed vaccinations; won’t hold back 2nd doses ( AP ) ( Reuters ) ( Bloomberg ) Democrats demand plan...
  • ReconRecon

    Recon: BioNTech boosts vaccine output for 2021; Sanofi buys Kymab for up to $1.5B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax bosses cash out for $46 million with COVID-19 vaccine trials still under way ( Reuters ) Lilly says Alzheimer's drug slows clinical decline in mid-stage trial ( Reuters ) ( STAT ) Vertex Pharma taking more aggressive M&A stance, flush with cash from cystic fibrosis drugs ( STAT ) Bluebird Bio to Spin Off Cancer-Drug Unit ( WSJ ) ( STAT ) Biden dresses...
  • ReconRecon

    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 ) Whe...
  • ReconRecon

    Recon: CureVac partners with Bayer on COVID vaccines; Sinovac vaccine found 78% effective in Brazil trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna CEO says vaccine likely to protect for 'couple of years' ( Reuters ) Operation Warp Speed’s Moncef Slaoui will stay on as a consultant for Biden ( STAT ) ( Politico ) Serial biotech entrepreneur John Hood raises $62 million for company aimed at deadly lung disease ( STAT ) Generic drug makers fear a ‘skinny labeling’ court ruling will pose a huge threa...
  • ReconRecon

    Recon: Germany says it won’t delay second COVID vaccine dose; Alexion buys Rhythm PRV for $100M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Studies to see if Moderna COVID-19 vaccine doses can be halved may take two months ( Reuters ) So why is Alexion paying $100M for a PRV as AstraZeneca lines up their $39B buyout? ( Endpoints ) ( Fierce ) Walgreens Boots to Sell Pharmacy Wholesale Operation to AmerisourceBergen ( WSJ ) Trump administration speeds up plan to deliver Covid shots in pharmacies ( P...
  • ReconRecon

    Recon: Mexico authorizes AstraZeneca COVID vaccine; Woodcock returns to new role in Commissioner’s office

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers kick off 2021 with 500 US price hikes ( Reuters ) ( STAT ) Inovio expects to begin late-stage COVID-19 vaccine study in second quarter ( Reuters ) Most US COVID-19 vaccines go idle as New York, Florida move to penalize hospitals ( Reuters ) Haven, ambitious health venture backed by Amazon, to shut down ( STAT ) ( Reuters ) Many Health Plans Now Mus...
  • ReconRecon

    Recon: Catch up on the news you missed over the holidays

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers to hike prices for 2021 as pandemic, political pressure put revenues at risk ( Reuters ) ( BioPharmaDive ) Pfizer and BioNTech to offer COVID vaccine to volunteers who got placebo ( Reuters ) US distributes over 13.07M doses of COVID-19 vaccines; 4.2M administered -CDC ( Reuters ) US may cut some Moderna vaccine doses in half to speed rollout, offic...
  • ReconRecon

    Recon: Brexit trade deal reached; FDA places Altimmune COVID vaccine trial on hold

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Federal judge places restraining order on Trump’s latest drug pricing rule ( STAT ) ( Reuters ) FDA puts early-stage trial of Altimmune's COVID-19 vaccine on hold ( Reuters ) Nearly 9.5m doses of COVID-19 vaccines distributed, 1 million administered ( Reuters ) ( CNBC ) Coronavirus aid at risk as US lawmakers block Trump's changes ( Reuters ) In Focus: Inter...
  • ReconRecon

    Recon: US buys another 100M doses of Pfizer-BioNTech vaccine; AstraZeneca submits vaccine data to MHRA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, US strike 100 million COVID-19 vaccine deal with 70 million due by June ( Reuters ) ( Press ) US vaccine rollout's next challenge: Verifying who is 'essential' ( Reuters ) Supernus drug meets main goal of study in adults with ADHD ( Reuters ) ( Endpoints ) FDA slaps a hold on Voyager's lead gene therapy over 'MRI abnormalities' ( Endpoints ) Justice D...