• Regulatory NewsRegulatory News

    EMA's challenges through 2023: Global collaboration, supply shortages, antimicrobial resistance

    The European Medicines Agency (EMA) recently released its final programming document for 2021 to 2023, setting goals to address medicine availability and shortages, analysis and access to healthcare data, supply chain issues, and antimicrobial resistance.   Emer Cooke, EMA Executive Director, stated in the document’s foreword that much of the agency’s planning over the next few years will be accomplished by implementing the EMA Network Strategy and Regulatory Science S...
  • ReconRecon

    Recon: CureVac pulls back its COVID mRNA vax; Medtronic's new robotics bid

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency ( FDA ) FDA still without a permanent leader as clock ticks down on acting head ( CNN ) IPO floodgates open up after summer lull as five more biotechs file for Nasdaq ( Endpoints ) FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are...
  • Regulatory NewsRegulatory News

    FDA to convene VRBPAC on vaccines for younger children plus Moderna, J&J boosters

    Amid the nationwide rollout of booster shots of the Pfizer-BioNTech COVID-19 vaccine, the US Food and Drug Administration (FDA) on Friday announced it will convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to discuss potential booster doses for the other two US-authorized COVID-19 vaccines developed by Moderna and Johnson & Johnson (J&J) later this month.   The committee will also meet on 26 October to discuss Pfizer's anticipated request...
  • Regulatory NewsRegulatory News

    Should the US government share the Moderna COVID vaccine recipe?

    As much of the developing world struggles to gain access to COVID-19 vaccine doses, some legal experts say the key lies in having the US government share the step-by-step instructions for manufacturing and testing the Moderna mRNA vaccine with other manufacturers.   In a recent Health Affairs blog , Christopher J. Morten, Zain Rizvi, and Ameet Sarpatwari made the case that the US government, through its contract with Moderna, has both access to the details of how the ...
  • Regulatory NewsRegulatory News

    Comirnaty booster gets adcomm thumbs up, for limited population

      An advisory committee to the US Food and Drug Administration (FDA) voted 16-2 on Friday against approval of a third booster dose added on to the 2-dose regimen for Pfizer’s COVID-19 vaccine Comirnaty. However, the committee voted unanimously in favor of an emergency use authorization (EUA) for booster doses for those aged 65 years and up, as well as health care workers and other individuals at high risk for COVID-19 because of occupational exposure.   The ball is n...
  • Regulatory NewsRegulatory News

    In advance of adcomm, Pfizer makes its case for Comirnaty booster

    In briefing documents made available on Wednesday in advance of a US Food and Drug Administration (FDA) meeting, Pfizer made the case that a third dose of its COVID-19 vaccine would address an unmet public health need in the face of high and persistent levels of Delta variant breakthrough infections among the vaccinated.   Pfizer’s application for a supplemental biologics license application (sBLA) for Comirnaty, the messenger RNA (mRNA) COVID-19 vaccine it co-develope...
  • Regulatory NewsRegulatory News

    Convergence: Plenary probes how FDA, EMA will move forward

    During the opening plenary session for RAPS Convergence 2021, leading regulators from the US and EU moved beyond the now-obligatory discussion of lessons learned from the pandemic to a substantive review of how the agencies are really faring a year and a half into the public health emergency of the COVID-19 pandemic.   Speaking to an audience of regulatory experts in attendance at the virtual conference, Janet Woodcock, acting commissioner of the US Food and Drug Admin...
  • Regulatory NewsRegulatory News

    US to continue international inspection cooperation, says Marks

    Some of the US Food and Drug Administration’s (FDA’s) pandemic-related changes are likely here to stay, a top FDA official told Focus .   In the leadup to RAPS Convergence 2021, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), spoke with Focus about how CBER’s pandemic pivot accelerated a trend toward global cooperation, and how the changes stand to benefit patients and industry going forward.   Business as usual came to a halt...
  • Regulatory NewsRegulatory News

    FDA convenes adcomm for Pfizer COVID booster

    The US Food and Drug Administration (FDA) announced late Wednesday afternoon that it plans to hold an advisory committee meeting on 17 September to discuss a third booster shot of the Pfizer-BioNTech COVID-19 vaccine for individuals aged 16 years and up.   "The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental Biologics License Application for its COVID-19 vaccine and will discuss it with the agency's advisory committee to inform our decision-making...
  • 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...
  • Regulatory NewsRegulatory News

    Clinical trial site remote monitoring may suffice: Updated FDA guidance

      Remote monitoring to oversee clinical trials has been one of the flexibilities the US Food and Drug Agency (FDA) has, in some cases, permitted during the COVID-19 pandemic. Now that some pandemic-related restrictions are lifted, though, does remotely obtained site information “count,” or do these sites need to be re-monitored in person?   To respond to this knowledge gap, a new question and accompanying answer (Q and A) have been appended to the final guidance docu...
  • 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...