• ReconRecon

    Recon: Biotech's 'coolers of cash;' Slipping pharma halo?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cavazzoni Begins Putting Her Mark On FDA Drug Center With New Principal Deputy Position ( Pink Sheet ) ( Biocentury ) The Delta Variant Is The Dominant Coronavirus Strain In The U.S. ( NPR ) ( Reuters ) COVID-19 cases up in nearly half of US states: analysis ( The Hill ) Maryland says 100 percent of COVID-19 deaths last month were among unvaccinated ( The Hill...
  • ReconRecon

    Recon: AZ's $39B bid for Alexion cleared by EC; Leo taps X-Chem for derm drugs

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci: More than 99% of people who died from COVID-19 in June were not vaccinated ( The Hill ) The White House is taking right approach in fighting the Covid-19 delta variant, Gottlieb says ( CNBC ) Biden’s grand plan: ‘Blue Sky’ research to solve the biggest health problems ( MedCity News ) As COVID Vaccinations Slow, Parts Of The U.S. Remain Far Behind 7...
  • Regulatory NewsRegulatory News

    EC issues first COVID therapeutics portfolio

    As part of its strategy for COVID-19 therapeutics, the European Commission (EC) on Tuesday released a portfolio of the initial five therapeutics being considered for authorization for the treatment of COVID-19 patients.   Four of the candidate therapeutics are monoclonal antibodies in consideration under the European Medicines Agency’s rolling review process. The fifth therapeutic being considered, Eli Lilly’s Olumiant (baricitinib), is an orally administered immunosup...
  • Regulatory NewsRegulatory News

    EMA management board report: COVID coping, CTIS updates and more

    The management board of the European Medicines Agency (EMA) gave a generally positive assessment of the agency’s work through the COVID-19 pandemic, according to recently released highlights of the board’s June meeting.   The board has begun the process of conducting a formal reflection on lessons learned from the pandemic, with a more detailed discussion expected when the board reconvenes in October.   EMA’s board also reviewed the agency’s 2020 annual report publ...
  • Regulatory NewsRegulatory News

    Regulatory science pilot floated in BsUFA III negotiations

    In the latest rounds of negotiations for the reauthorization of the Biosimilar User Fee Act (BsUFA III), industry and the US Food and Drug Administration (FDA) fine-tuned labeling and supplements language, sought to find new ways for developers to receive targeted feedback, and set the scope for future guidance documents.   In a series of three May 2021 meetings, the BsUFA III negotiation steering committee convened to work on these topics, and to hammer out an agreeme...
  • ReconRecon

    Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine ( NYT ) ( NPR ) ( Reuters ) Another Sad Coronavirus Pandemic Milestone Is Approaching ( NPR ) U.S. Not On Pace To Meet Biden's Vaccination Goal ( NPR ) Eight states see rise in new COVID-19 infections ( The Hill ) U.S. has administered over 309 million doses of Covid-19 vaccines, CDC says ( CNBC ) How did ...
  • ReconRecon

    Recon: CMS head confirmed; EU seeks breach-of-contract fine from AZ

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden's CMS head confirmed, but FDA pick remains elusive ( Axios/Yahoo ) BARDA Funding Freeze Risks Companies Abandoning COVID Therapeutic Work ( Pink Sheet ) CDC: Half of US adults now vaccinated against COVID-19 ( The Hill ) Pandemic creates 500-site backlog for FDA, despite decade of dwindling US inspections ( Pharma Tech ) The Vaccine Rollout Is Changing ...
  • ReconRecon

    Recon: ASCO 21 updates; Moderna goes for teen EUA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says that its vaccine is effective for 12- to 17-year-olds and that it will seek F.D.A. authorization ( NYT ) ( NPR ) President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals ( Fortune ) Bipartisan Legislation Introduced to Advance Biomedical Research Stalled by Pandemic ( Global Genes ) ...
  • ReconRecon

    Recon: NGM's NASH drug fails; Alzheimer's breakthrough?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Covid cases hit lowest level since June ( CNBC ) ( NPR ) Scott Gottlieb says vaccinations are not the only factor driving U.S. Covid cases down ( CNBC ) Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health (Harvard Law blog ) Covid vaccine passports: Everything we know so far ( CNBC ) White House says no plans to require vacci...
  • Regulatory NewsRegulatory News

    Euro Convergence Day 3: AI's regulatory framework, the future of ATMPs, and more

    As Euro Convergence 2021 draws to a close, the European regulatory affairs community will gather virtually to hear updates on artificial intelligence and cell and gene therapies, and to explore how post-marketing surveillance will change in the upcoming years.   Use of artificial intelligence (AI) is seeping into more and more corners of healthcare, and those working in medical devices need to know how regulators address these technologies. Pat Baird, a senior regulato...
  • Regulatory NewsRegulatory News

    FDA tallies pandemic inspection toll, issues new 'resiliency roadmap'

    A new report from the US Food and Drug Administration details its performance on inspections during the public health emergency of the COVID-19 pandemic and details the agency’s roadmap going forward.   “The numbers reveal the state of our inspectional oversight and how we plan to address postponed inspectional work using a risk-based approach,” wrote acting FDA director Janet Woodcock, MD, in a forward to the Resiliency Roadmap for FDA Inspectional Oversight .   ...
  • ReconRecon

    Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters ) Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms ( STAT ) Rising wholesale drug prices really do matter to half of all commercially insured Americans ( STAT ) Facing fresh pricing threats in D.C., pharma spent a record $92...