• ReconRecon

    Recon: Moderna lifts guidance on COVID vaccine sales; US backing of patent waiver causes stir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US backs giving poorer countries access to COVID-19 vaccine patents, reversing stance ( Reuters ) ( STAT ) ( NYTimes ) ( Endpoints ) ( Harvard Bill of Health ) ( KEI ) ( Patent Docs ) Drugmakers say Biden misguided over vaccine patent waiver ( Reuters ) ( FT ) Global pharma shares slide as Biden backs COVID-19 vaccine IP waiver ( Reuters ) Explainer: COVID-19 ...
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    Recon: Pfizer plans COVID vaccine BLA submission this month; Gilead sues Russia over remdesivir compulsory license

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month ( CNBC ) The FDA is set to authorize the Pfizer-BioNTech vaccine for those 12-15 years old by early next week. ( NYTimes ) Pfizer Reaps Hundreds of Millions in Profits From Covid Vaccine ( NYTimes ) ( WSJ ) ( Endpoints ) ( Reuters ) White House to shift COVID-19 vaccine to sta...
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    Recon: WV opioid MDL bellwether gets underway; Moderna, Sweden deals give boost to COVAX

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Feds rethink vaccination strategy as slowing demand reveals stark divide ( Politico ) US to launch trade talks on COVID-19 vaccine distribution ( AP ) ( CNBC ) Drug distributors face off against West Virginia in billion-dollar opioid trial ( Reuters ) ( Law360 ) Roivant valued at $7B in blank-check merger, bucking SPAC slowdown ( BioPharmaDive ) ( STAT ) Next...
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    Recon: Executive shakeup at Emergent; Global drug spending to hit $1.6T by 2025, says IQVIA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca on track to submit data for US vaccine approval, says chief ( FT ) ( Reuters ) AstraZeneca Struggles With Data Needed for Covid-19 Vaccine’s Approval ( WSJ ) FDA panel wrestles through multiday cancer drug meeting ( Politico ) Merck, Roche and Bristol Myers nab 4 of 6 positive ODAC votes for ‘dangling’ accelerated approvals ( Endpoints ) An Alzhei...
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    Recon: Global spending on COVID vaccines to exceed $150B through 2025; BMS misses in Q1 as cancer drugs underperform

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna boosting COVID-19 vaccine capacity, targets up to 3 billion shots in 2022 ( Reuters ) BMS Q1 earnings miss expectations as cancer drugs underperform ( Reuters ) ( Press ) ( Endpoints ) US trade negotiator discusses COVID-19 IP waiver with Moderna CEO ( Reuters ) With Amy Abernethy out, Vid Desai takes over as FDA’s acting CIO ( Endpoints ) Gene therap...
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    Recon: US ups Moderna vaccine contract; Pfizer buys Amplyx

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US govt boosts Moderna COVID-19 vaccine contract to $1.25B ( Reuters ) ( Endpoints ) US probing two new blood clot cases after J&J's COVID-19 vaccine ( Reuters ) ( Press ) Pfizer buys Amplyx to expand drug-resistant treatment portfolio ( Reuters ) ( Endpoints ) Top US trade negotiator discussed vaccine ramp-up with Novavax exec ( Reuters ) Novavax shares jump...
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    Recon: HHS moves to expand buprenorphine treatment; Lilly misses on profit as COVID antibody demand wanes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Eli Lilly profit misses as vaccines sap US demand for COVID-19 drugs ( Reuters ) ( STAT ) ( Press ) Top US trade negotiator meets Pfizer, AstraZeneca execs on COVID-19 IP waiver ( Reuters ) As opioid deaths surge, Biden team moves to make buprenorphine treatment mainstream ( NPR ) ( HHS ) Bio­gen re­vers­es course on com­pas­sion­ate use for ALS drug tofersen ...
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    Recon: Sanofi to help manufacture Moderna vaccine; EU sues AZ over vaccine supply issues

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US ends J&J COVID-19 vaccine pause; shots to resume immediately ( Reuters ) ( STAT ) ( FDA ) Sanofi to Help Make Moderna Covid-19 Vaccine for US ( WSJ ) ( Press ) Millions Are Skipping Their Second Doses of Covid Vaccines ( NYTimes ) FDA lifts hold on UniQure gene therapy study after review of cancer case ( BioPharmaDive ) ( Endpoints ) FDA to scrutinize unpr...
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    Recon: US pulls funding for Inovio COVID vaccine study; EU seeks 1.8 billion more doses of Pfizer-BioNTech vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US With Few New Clotting Cases, J&J Pause Could Be Lifted Soon ( NYTimes ) ( WSJ ) ( Reuters ) ( FT ) White House writes off Johnson & Johnson vaccine after string of production failures ( Politico ) US CDC probes new death, hospitalization after J&J vaccine shots – officials ( Reuters ) US stops funding for late-stage study of Inovio's COVID-19 vaccine ( Reuters...
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    Recon: EU preparing legal case against AstraZeneca; WHO, EMA set to inspect Sputnik facility in May

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA finds mess of sterility problems at Emergent ( Focus ) ( NYTimes ) ( STAT ) ( Politico ) Federal Inspectors Fear More Vaccines Were Exposed to Contamination ( NYTimes ) Worried drug pricing reform might be left behind, Democrat pushes Biden to make clear his support ( STAT ) ( The Hill ) A look ahead at the FDA meeting that could decide the future of 6 can...
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    Recon: FDA orders Emergent to halt vaccine production during inspection; Adagio raises $336M to advance COVID antibody treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA orders J&J contractor Emergent to stop vaccine production during inspection ( Politico ) ( Reuters ) ( Endpoints ) ( SEC filing ) Doctors say clot treatment advice key to U.S. resuming J&J COVID vaccines ( Reuters ) J&J scientists refute ‘class effect’ to blame for clots in those who got its COVID-19 vaccine ( Reuters ) J&J, others face California trial ov...
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    Recon: Lilly seeks revocation of bamlanivimab EUA; J&J asked other COVID vaccine makers to join clot probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly asks FDA to not allow lone use of COVID-19 drug bamlanivimab ( Reuters ) ( Endpoints ) ( Press ) J&J Privately Asked Rival Covid-19 Vaccine Makers to Probe Clotting Risks ( WSJ ) ( Reuters ) US advisory committee to meet next week to discuss J&J COVID-19 vaccine ( Reuters ) ( Endpoints ) ( The Hill ) Biden administration investing $1.7B to better track C...