• ReconRecon

    Recon: Lilly receives subpoena over COVID drug manufacturing site; FDA grants EUA for GSK-Vir antibody drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Eli Lilly receives DoJ subpoena over COVID-19 drug manufacturing plant ( Reuters ) ( Endpoints ) US FDA gives emergency use approval for GSK-Vir COVID-19 antibody drug ( Reuters ) ( FDA ) US pauses use of Eli Lilly Covid-19 mAb combo in six more states due to variants from Brazil, India ( Endpoints ) FDA adds new 'do not use' note to Intercept's Ocaliva label ...
  • ReconRecon

    Recon: BMS’ Opdivo wins full FDA approval for resected esophageal or GEJ cancer; Japan authorizes Moderna, AZ COVID vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Full OK for Covid Shots Will Take Months, FDA Vaccine Chief Says ( Bloomberg ) FDA Approves First Targeted Therapy for Subset of Non-Small Cell Lung Cancer ( FDA ) FDA recommends not using syringes from Chinese firm after safety issues with vaccine injections ( Reuters ) ( FDA ) BMS’ Opdivo wins FDA approval for resected esophageal or GEJ cancer ( Endpoints ) ...
  • ReconRecon

    Recon: FDA extends fridge storage for Pfizer vaccine; Catch up on news from ASCO

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID-19 vaccine can be stored in refrigerator for a month, U.S. says ( Reuters ) ( FDA ) Fauci expects COVID-19 vaccines for kids in late-2021, sees need for booster shot ( Reuters ) New Bristol Myers immunotherapy combo better than Opdivo alone in melanoma study ( Reuters ) ( STAT ) Emergent may be able to resume J&J COVID-19 shot production 'within d...
  • ReconRecon

    Recon: Emergent execs face grilling on the Hill; Bristol-Myers enters $1.2B AI pact

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Emergent was aware of vaccine manufacturing issues even as it collected $27 million a month from US ( STAT ) ( The Hill ) ( Politico ) ( CNBC ) ( Washington Post ) Troubled Vaccine Maker and Its Founder Gave $2 Million in Political Donations ( NYTimes 1 , 2 ) Bristol-Myers pays up to $1.2bn to enter artificial-intelligence pact ( FT ) ( Endpoints ) Democrats ...
  • ReconRecon

    Recon: FDA rebukes CytoDyn over COVID drug claims; BMS to pay up to $1.4B for Agenus cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA issues major rebuke to CytoDyn over claims on Covid-19 drug ( STAT ) ( Endpoints ) ( FDA ) Biden Pledges to Export Millions of FDA-Authorized Vaccines ( Bloomberg ) ( Reuters ) ( Politico ) Bristol to pay up to $1.38B to develop, sell Agenus's cancer therapy ( Reuters ) ( Endpoints ) ( Press ) Roche COVID test receives U.S. greenlight for asymptomatic peop...
  • ReconRecon

    Recon: FDA releases hundreds of pages of Trump-era emails; Biogen gene therapy misses study goals

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Internal Trump-era emails reveal a plethora of celebs, companies vying for FDA’s attention ( Endpoints ) ( Politico ) ( FDA ) Biogen's experimental eye treatment fails to meet study goal ( Reuters ) ( Endpoints ) Fully vaccinated people can shed their masks in most places - CDC ( Reuters ) ( STAT ) Adolescents Can Get Routine Immunizations With Their COVID Sho...
  • ReconRecon

    Recon: FDA approves Heron’s non-opioid anesthetic; Poll suggests low public trust in US health institutions

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CDC Advisers Endorse Pfizer Vaccine for Children Ages 12 to 15 ( NYTimes ) ( Reuters ) ( STAT ) US CDC finds more clotting cases after J&J vaccine, sees causal link ( Reuters ) ( NBC ) ( NYTimes ) Covid vaccines may not protect people with immune disorders. NIH trial seeks answers. ( NBC ) Poll Finds Public Health Has A Trust Problem ( NPR ) ( RWJF ) Third ti...
  • ReconRecon

    Recon: Emergent execs to testify before house panel; ACIP weighs Pfizer vaccine in adolescents

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID-19 vaccine works for adolescents, CDC panel told ( Reuters ) Pelosi drug price plan threatened by centrist defections ( Politico ) ( STAT ) Illumina CEO insists GRAIL merger will be good for competition, and ultimately, patients ( STAT ) AbbVie Slapped With Suit From Would-Be Humira Rival ( Law360 ) ( Fierce ) Sanofi is accused of ‘widespread des...
  • ReconRecon

    Recon: MiNA enters $1.25B partnership with Eli Lilly; EU launches new lawsuit against AstraZeneca in vaccine spat

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Authorizes Pfizer-BioNTech Vaccine for Children 12 to 15 ( NYTimes ) ( Politico ) ( FDA ) US children ages 12 to 15 could begin COVID-19 vaccinations Thursday ( Reuters ) Novavax delays timelines for COVID-19 vaccine regulatory filings, production ( Reuters ) ( The Hill ) Inovio to start global late-stage COVID-19 vaccine trial this summer ( Reuters ) Flo...
  • ReconRecon

    Recon: Lilly signs deals to boost India supply of antibody drugs; Inovio says COVID vaccine safe, effective in Ph. 2

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Inovio says COVID-19 vaccine candidate safe, effective in mid-stage trial ( Reuters ) AstraZeneca weighs seeking full approval for Covid shot, skipping EUA ( WSJ ) ( Reuters ) Novavax not expected to seek COVID vaccine authorization until June at the earliest ( Washington Post ) Biden administration signals that FDA may allow abortion pill access via mail even...
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    Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ) Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ) How Big Pharma finds sick users on Facebook ( TNW ) ( Ars ) Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ) The US opened pandora’s box on IP...
  • Regulatory NewsRegulatory News

    Pharma groups slam US decision to support COVID-19 vaccine patent waivers

    Pharmaceutical industry groups in the US and the EU lambasted a recent decision by the Biden Administration to support a proposal pending in the World Trade Organization (WTO) that would waive intellectual property patents for coronavirus vaccines, charging that the waiver is a bad idea that would compromise vaccine efficacy and safety. Their views clash with World Health Organization’s (WHO) arguments and other groups that the waiver is necessary to increase access to th...