• 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...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on studying CNS metastases in cancer trials

    A final guidance document from the US Food and Drug Association (FDA) provides recommendations for drug developers on how best to evaluate the safety and efficacy of cancer drugs in patients with central nervous system (CNS) metastases. The document finalizes a draft guidance issued in August 2020.   "There are few effective treatments for patients with central nervous system (CNS) metastases – a type of cancer that has spread from the original tumor to the CNS and is ...
  • 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 gives procedural guidance on variant COVID vaccines

    A new document from the European Medicines Agency (EMA) will give vaccine developers procedural guidance when the time comes for them to update COVID-19 vaccines to include protection against variant strains of SARS-CoV-2.   The procedural guidance was adopted by EMA’s human medicines committee on 24 June, and is meant to apply to vaccines against other human coronaviruses as well. Marketing authorization holders may submit a variation to change the composition of a CO...
  • 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

    FDA 'may require' post-marketing studies to analyze long-term effects of breast cancer drugs

    The US Food and Drug Administration (FDA) "may require” or seek agreement from sponsors to conduct post-marketing studies to analyze long term effects of breast cancer drugs in both pre- and post-menopausal women in a final guidance issued on 17 June. The guidance also provides other considerations for sponsors as they plan for the inclusion of premenopausal women in clinical trials of drugs for breast cancer treatment.   According to the agency’s announcement of the f...
  • EC proposes crisis-related devices role for EMA

    The European Council (EC) has proposed that the European Medicines Agency (EMA) take a stronger role in crisis management and preparedness, increasing its administrative oversight of medicinal products and also medical devices during emergencies such as the recent COVID-19 pandemic.   The proposal, first drafted in November 2020, is part of a triad of documents “aiming to strengthen the EU's health security framework and to reinforce the crisis preparedness and respons...
  • Feature ArticlesFeature Articles

    The transition to ICH M10 and its impact on global submissions

    With the expanding globalization of drug development, regulations put forth under the International Council for Harmonisation’s (ICH’s) M10 guidance support the transition to a more harmonized industry. The draft guidance marks another step of integrating international expectations, in this case, as it applies to bioanalytical evaluations. This article examines the key elements of the M10 standard and recommends strategies for successful new drug or clinical trial applicat...
  • Regulatory NewsRegulatory News

    Brexit, COVID-19 headline EMA’s 2020 annual report

    The European Medicines Agency (EMA) started 2020 by wrapping up challenges associated with the UK’s decision to leave the EU, only to run headlong into additional challenges brought on by the COVID-19 pandemic. In the annual report that also marked the agency’s 25 th anniversary, EMA outlined a year that looked different than most.   “As the scientific body in charge of the regulation of medicines, EMA had an essential part to play in ensuring treatments and vaccines ...
  • 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 ...
  • Regulatory NewsRegulatory News

    IVDR: MDCG charts rollout in new implementation plan

    The European Commission’s Medical Device Coordination Group (MDCG) this week released its joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR) set to take effect next May.   With the date of application of the Medical Devices Regulation (MDR) now in the rear view, MDCG’s attention is turned to challenges on the horizon related to IVDR. MDCG previously released a joint implementation plan for MDR in March 2020, bef...