• ReconRecon

    Recon: Kerfuffle over WHO's Wuhan mission; BMS inks $1.3 B cancer deal

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New, Daily Coronavirus Cases Drop Below 100K For First Time In Months ( NPR ) U.S. Continues To Accelerate Vaccination Strategy ( NPR ) Seven coronavirus variants potentially similar to UK type have been detected in US: study ( The Hill ) ( NYT ) Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic ( NPR ) Pentago...
  • Regulatory NewsRegulatory News

    FDA warns Florida drugmaker for GMP violations

    The US Food and Drug Administration (FDA) last month warned Hialeah, FL-based drugmaker Allay Pharmaceuticals over good manufacturing practice (GMP) issues identified during a rare on-site inspection during the COVID-19 pandemic.   The warning letter cites the company for four issues observed during an inspection in May 2020 involving subpotent products and active pharmaceutical ingredient (API) testing lapses.   FDA says the company “failed to establish written pr...
  • Regulatory NewsRegulatory News

    CureVac's COVID vaccine enters EMA's rolling review

    The European Medicines Agency (EMA) has begun a rolling review of another vaccine against COVID-19, the agency announced Friday.   EMA’s human medicines committee (CHMP) will review available data on CureVac’s messenger RNA (mRNA) vaccine CVnCoV. The vaccine is currently being tested in a Phase 2b/3 clinical trial of about 36,000 participants in Germany, as well as in a German Phase 3 trial involving healthcare workers.  (RELATED: COVID-19 vaccine tracker , Regul...
  • Regulatory NewsRegulatory News

    European Commission explains management of legacy devices in Eudamed

    The European Commission this week posted a new document explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database.   After being delayed in 2019, Eudamed, a critical component of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched with the first of its six modules operational in December 2020. The remaining five modules are expected to roll out by the database’s May 2022 date of a...
  • ReconRecon

    Recon: FDA approves Regeneron antibody for rare cholesterol disorder; EMA says kidney problems not related to remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Agrees Moderna Can Increase Vaccine Supply in Each Vial ( NYTimes ) As Millions Get Shots, FDA Struggles to Get Safety Monitoring System Running ( NYTimes ) Biden administration finalizes purchase of 200M additional vaccine doses ( Politico ) ( NPR ) ( NYTimes ) Biden says there will not be enough COVID vaccines by end of summer to vaccinate all Americans ...
  • Feature ArticlesFeature Articles

    Navigating the maze of electronic submissions at EMA

    The European Medicines Agency (EMA) facilitates a range of different submissions and application processes using several submission systems for electronic procedures, which have clear advantages over paper-based submissions. At present, first-time applicants cannot proceed with a regulatory submission unless they have set up several accounts and assigned roles and registered their companies and their assets. However, there is no “one-stop-shop” place on the EMA website for...
  • FDA’s OPQ reports on drug quality efforts in 2020

    The office tasked with overseeing pharmaceutical quality within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) released its annual report for 2020 on Thursday, highlighting its effort in a year marked by the COVID-19 pandemic.   In its previous annual report, the Office of Pharmaceutical Quality (OPQ) touted its participation in nearly one third of the preapproval inspections FDA carried out in 2019. For 2020, OPQ instead foc...
  • Regulatory NewsRegulatory News

    White paper addresses immuno-oncology's growing pains

    Characterizing cytokine release syndrome (CRS) will be key to ensuring broader uptake of advanced cell and gene therapies in the field of immuno-oncology, agreed authors of a newly issued white paper addressing CRS.   Speaking at a webinar hosted by the Friends of Cancer Research, Peter Marks, MD, head of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER), also noted that better characterization of manufacturing process must...
  • ReconRecon

    Recon: Novo’s semaglutide shows promise for weight loss in Phase III trial; EU nears deal with Novavax

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck in talks with governments, other drugmakers to produce COVID-19 shots ( Reuters ) How Merck, a Vaccine Titan, Lost the Covid Race ( NYTimes ) Can’t Find an N95 Mask? This Company Has 30 Million That It Can’t Sell. ( NYTimes ) OWS: Accelerated COVID-19 Vaccine Development Status and Efforts to Address Manufacturing Challenges ( GAO ) Biden admin asks SCO...
  • RoundupsRoundups

    Euro Roundup: NICE seeks feedback on how it develops health technology guidance

    The UK National Institute for Health and Care Excellence (NICE) is seeking feedback on its proposals to create a simplified, single process for all technology evaluations and gain the flexibility to assess new and emerging health technologies. Feedback is being accepted until 15 April.   “To continue to support the needs and aspirations of all parts of the healthcare and life sciences ecosystem, NICE must ensure that its processes of health technology evaluation mainta...
  • Regulatory NewsRegulatory News

    Fresenius Kabi pays $50 million to settle criminal charges

    An Indian drug manufacturer has agreed to pay $50 million in fines and forfeitures, the US Department of Justice announced Tuesday. Fresenius Kabi Oncology Limited (FKOL) plead guilty to concealing and destroying records; the charges came in the wake of a 2013 US Food and Drug Administration (FDA) inspection of its plant in Kalyani, India.   “By hiding and deleting manufacturing records, FKOL sought to obstruct the FDA’s regulatory authority and prevent the FDA from do...
  • RoundupsRoundups

    FDA Approvals Roundup: Breyanzi, Ukoniq, Libtayo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Breyanzi okayed for relapsed/refractory large B-cell lymphoma Juno’s Breyanzi (lisocabtagene maraleucel) has been approved for previously treated adults with relapsed or refractory large B-cell lymphoma ( LBCL ), including diffuse large B-cell lymphoma not otherwise specified, high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular ...