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  • ReconRecon

    Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Daily U.S. Covid cases remain above 70,000 amid Johnson & Johnson vaccine pause ( CNBC ) Fauci, Jim Jordan spar over pandemic restrictions ( The Hill ) What’s behind the wait on a J&J vaccine verdict ( Politico ) ( NYT ) ( WSJ ) The J&J Vaccine Pause Is Science Working Like It’s Supposed To ( Slate ) Why the Johnson & Johnson pause may not matter for Amer...
  • Regulatory NewsRegulatory News

    "Very rare" thrombotic events with AZ vaccine, concludes EMA's PRAC

    AstraZeneca’s COVID-19 vaccine may have a “very rare” but serious side effect of unusual blood clotting with a low blood platelet account, concluded the safety committee of the European Medicines Agency (EMA). The benefits of receiving the vaccine still outweigh risks, said the committee, hewing to the line EMA has held to throughout the investigation into reports of clotting events with the AstraZeneca vaccine.   The conclusion reached by EMA’s Pharmacovigilance Ris...
  • ReconRecon

    Recon: EMA says 'possible' AZ-blood clot link; Invitae's $1.2B gene testing investment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. begins study on allergic reaction risk in Moderna, Pfizer vaccines ( NIH ) ( Reuters ) CDC says variant from the UK is now the most common strain circulating in the U.S. ( CNBC ) U.S. delivering about 3 million COVID-19 vaccines per day, up 8%: CDC director ( Reuters ) U.S. surpasses 150 million vaccine shots under Biden, on track to hit President’s new 2...
  • Regulatory NewsRegulatory News

    How to reduce bias, improve fairness in medical devices

    Lessons learned in the artificial intelligence community about addressing bias could also be applied to medical devices, according to a recent perspective in the journal Science .   “Initiatives to promote fairness are rapidly growing in a range of technical disciplines, but this growth is not rapid enough for medical engineering. Although computer science companies terminate lucrative but biased facial recognition systems, biased medical devices continue to be sold a...
  • FDA, EMA team up on pediatric oncology drug development template

    In a move that dovetails with other cooperative efforts in regulation of pediatric oncology drugs, regulators in the US and Europe have come together to provide a common template for drugmakers to use when planning clinical trials for pediatric cancer drugs.   A new Common Commentary template gives a framework for seeking scientific advice from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on new Pediatric Investigation Plans ...
  • Regulatory NewsRegulatory News

    AstraZeneca vaccine deemed safe by EMA, again

    In a Wednesday status update on the European Medicines Agency's (EMA's) ongoing investigation into rare reports of blood clotting problems in people who have received the AstraZeneca COVID-19 vaccine, EMA head Emer Cooke offered reassuring words about the vaccine’s benefit-risk profile.   “Two weeks ago, on the 18th of March, we gave an interim update of the assessment and we concluded at the time that the benefits of the AstraZeneca vaccine in preventing COVID-19 -- w...
  • Regulatory NewsRegulatory News

    CHMP recommends five new drugs, gives advice on Celltrion COVID antibody

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday issued positive opinions for five new medicines and six extensions of therapeutic indications following its meeting earlier this week.   The newly recommended medicines include Verastem’s Copiktra (duvelisib) to treat relapsed or refractory chronic lymphocytic leukemia and refractory follicular lymphoma and Janssen-Cilag’s multiple sclerosis treatment Ponvory (ponesimo...
  • Regulatory NewsRegulatory News

    EC advances amendment to speed adapted COVID vaccines

    The European Commission on Wednesday advanced a delegated regulation that would give the European Medicines Agency (EMA) the authority to more quickly authorize COVID-19 vaccines that have been adapted to address variants of the virus.   “We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus,” said European Commission President Ursu...
  • Regulatory NewsRegulatory News

    COVID innovation lessons could be applied elsewhere

    The global urgency of the COVID-19 pandemic spurred the development of new models of vaccine and drug development. Could these innovations help with researching non-pandemic vaccines or drugs, and potentially serve as a template in other areas of medicine?   Two papers recently published in Health Affairs suggest that, yes, these innovations could be applied elsewhere if deemed successful—but it’s also important to note the shortcomings of these new models as well. ...
  • Regulatory NewsRegulatory News

    No ivermectin for COVID, says EMA

    The antihelmintic drug ivermectin should not be used for COVID-19 treatment outside of the clinical trial environment, according to a statement issued Monday by the European Medicines Agency (EMA).   The European regulator’s statement parallels the position of the US Food and Drug Administration (FDA), which issued a 5 March update for consumers in response to “multiple reports of patients who have required medical support and been hospitalized after self-medicatin...
  • ReconRecon

    Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies ( Pink Sheet ) Experts Warn U.S. Could See New Coronavirus Hot Spots ( NPR ) Biden says 65% of people 65 or older have received at least one COVID vaccine shot ( Reuters ) Drugmakers brace for a pricing fight as Xavier Becerra is confirmed as the next HHS secretary ( Endpoints ) New HH...
  • Regulatory NewsRegulatory News

    EMA judges AstraZeneca vaccine safe after blood clot investigation

    After an all-day meeting that ran beyond its scheduled end, the safety committee of the European Medicines Agency (EMA) concluded Thursday that the benefits of receiving the AstraZeneca COVID-19 vaccine outweigh any potential risks of side effects, including thromboembolic events.   Overall, the rate of clotting events was not higher in vaccine recipients than in the general population. However, PRAC, EMA’s safety committee, is paying attention to a small subset of eve...