• Regulatory NewsRegulatory News

    EU committee considers antimicrobial incentives, repurposing oncology drugs

    During a recent joint meeting of the European Union (EU) Directors for Pharmaceutical Policy and the Pharmaceutical Committee, members debated potential ways to combat antibiotic resistance and improve access to oncology medicines through the repurposing of older or generic medications.   The meeting, held via video conference on 08-09 July 2021, was co-organized and co-chaired by the Slovenian Presidency of the Council of the EU and the European Commission, with atten...
  • ReconRecon

    Recon: Novartis' Leqvio nabs NICE nod; HebeCell makes a foray into CAR-NK space

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US When Will the Delta Surge End? ( NYT ) Why can’t America fix its Covid-19 testing problems? ( VOX ) Vaccination Rates Rose In August As COVID Cases Surged Due To The Delta Variant ( NPR ) First vaccination doses up 17 percent since Pfizer approval: analysis ( The Hill ) Companies eye financial penalties for unvaccinated workers ( The Hill ) America has waste...
  • ReconRecon

    Recon: Gruber and Krause to leave CBER; Sanofi refiles with FTC on $3.2B Translate Bio buyout

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Percentage of Americans who say they won't get vaccinated drops to record low in new poll ( The Hill ) US demand for COVID-19 antibody treatments rising fast ( PMLive ) CDC Staff Floats 'Risk-Based Approach' to Potential Booster Doses ( MPT ) CDC panel unanimously endorses full approval of Pfizer’s Covid vaccine for people 16 and older ( CNBC ) Nearly 1 m...
  • Regulatory NewsRegulatory News

    CBO: Proposed Medicare pricing plan could curb drug development

    A new drug development model released by the Congressional Budget Office (CBO) estimates a Medicare drug pricing bill like the one proposed by Democrats in the US House of Representatives could result in between 21 and 59 fewer drugs brought to market over the next three decades.   The Elijah E. Cummings Lower Drug Costs Now Act ( H.R. 3 ), introduced in the 116th Congress during the 2019-2020 legislative session, would require the Secretary of Health and Human Servi...
  • ReconRecon

    Recon: Baxter in late-stage talks for $10B Hillrom buy; Catalent drops $1B for gummy vitamin maker

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID-19 Deaths And Hospitalizations Continue To Rise In The U.S. ( NPR ) HHS Lifts Pause on Lilly's Monoclonal Antibody Combo, Sort Of ( MPT ) U.S. CDC advisers vote in favor of Pfizer COVID-19 vaccine ( Reuters ) Baxter in late-stage talks to buy Hillrom for about $10B: WSJ ( MedTech Dive ) Reimbursement begins slowly for Biogen’s expensive Alzheimer’s ...
  • Regulatory NewsRegulatory News

    EMA goes all in on big data

    The European Medicines Agency (EMA) and the EU’s Heads of Medicines Agencies (HMA) have issued an ambitious workplan for a joint steering group to tackle issues related to big data in healthcare and medicines development.   The steering group’s 2021-2023 work plan, adopted in June and published Friday, “aims to increase the utility of big data in regulation, from data quality through study methods to assessment and decision-making,” according to EMA’s big data webpage...
  • ReconRecon

    Recon: FDA investigates iPhone-pacemaker interference; Humacyte's $245M SPAC deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA warns of pacemaker-iPhone interference ( Healthcare IT News ) Opinion: Expanding the domestic public health supply chain is a matter of national security ( STAT ) BD gets emergency FDA nod for smartphone-enabled COVID-19 antigen test ( MedTech Dive ) Ivermectin Scripts, Poison Center Calls Boom During Delta Surge ( MPT ) U.S. COVID-19 tests again in short...
  • Regulatory NewsRegulatory News

    New MDCG guidance offers QMS roadmap for device repackaging, relabeling

    Notified bodies who certify quality management systems related to device repackaging and relabeling have new guidance from the European Commission’s Medical Devices Coordinating Group (EC’s MDCG).   The guidance covers activities conducted under Article 16(4) of the Medical Device Regulation (MDR) and the In Vitro Device Regulation (IVDR) related to repackaging and relabeling of medical devices. The overall goal of the notified body’s certification activities under t...
  • ReconRecon

    Recon: Pharma's rep down again; Roche ponies up $3B for Shape's RNA editing tech

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Six U.S. states do not join $26B opioid settlements with distributors, J&J ( Reuters ) ‘We Sent a Terrible Message’: Scientists Say Biden Jumped the Gun With Vaccine Booster Plan ( KHN ) Fauci says he hopes U.S. will have ‘some good control’ over Covid by spring 2022 ( CNBC ) American Medical Association calls for public, private sectors to mandate vaccines ( ...
  • ReconRecon

    Recon: FDA vax approval signals looming mandates; Pfizer's $2.3B Trillium takeover

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer's COVID Vaccine Gets Full Approval From The FDA ( NPR ) ( NYT ) ( NBC ) Biden calls on companies to mandate vaccines following FDA full approval ( The Hill ) Pentagon set to make Pfizer vaccine mandatory after FDA approval ( Reuters ) New York City, The Country's Largest School System, Mandates Teacher Vaccinations ( NPR ) The U.S. Is Getting a Cra...
  • ReconRecon

    Recon: NYT says Abbott destroyed COVID tests when sales dwindled; Woodcock out of running for FDA commissioner?

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Maker of Popular Covid Test Told Factory to Destroy Inventory ( NYT ) Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee ( Bloomberg ) Child Covid-19 hospitalizations soar, filling pediatric wings, data show ( NBC ) White House: More than one million vaccine doses administered in past 24 hours ( The Hill ) Three senators announce positive COVID-19...
  • RoundupsRoundups

    Euro Roundup: MHRA contemplates a new regulatory framework for personalized medicines

    MHRA seeks feedback on making personalized medicines at the point of care   The UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking input on whether the production of personalized medicines at the point of care (POC) is sufficiently different from standard manufacturing to require the creation of a new framework.   In contrast to traditional medicine manufacturing, where fewer facilities, working at scale, manufacture products for global distrib...