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    FDA reports rare complications with Pfizer COVID vaccine, updates J&J safety info

    A summary of results of near real-time monitoring of the safety of COVID-19 vaccines in  older individuals was reported Tuesday by the US Food and Drug Administration (FDA). The agency identified four potential health concerns associated with receiving one of the authorized vaccines.   Examining the database of Medicare health care claims for people aged 65 years and older who received the mRNA vaccine marketed by Pfizer/BioNTech, FDA identified four adverse events o...
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    EMA's PRAC weighs in on more vaccine side effects

    The European Medicines Agency (EMA) has weighed in on several rare adverse events for COVID-19 vaccines and one gene therapy for treating thalassemia in their latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting.   At its July meeting, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found mRNA-based COVID-19 vaccines, like Pfizer’s Comirnaty and the Moderna vaccine marketed in the EU as Spikevax, carry a small risk of myocarditis and pericarditis....
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    Recon: Biden and Democrats face dilemma on vaccine mandates; EU to discuss joint recognition of vaccine certificates with Russia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. FDA narrows patient group for Biogen's Alzheimer's drug ( Reuters ) Alzheimer antibody rush begins, as efficacy concerns remain ( Nature ) AstraZeneca-Amgen drug gets FDA speedy review as asthma treatment ( Reuters ) Death rates are declining for many common cancers in the U.S., report finds ( STAT ) HHS head: 'Absolutely the government's business' to kn...
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    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...
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    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...
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    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...
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    Shuren: Time to rethink FDA's device regulatory framework

    Rethinking the medical device regulatory framework has been on the mind of Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA), especially in light of lessons the agency learned during the COVID-19 pandemic.   When he became director at CDRH in 2009, Shuren said, the medical device industry was in a different place. “Innovators were bringing their technologies overseas, first due to incr...
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    Include cancer patients in COVID-19 vaccine trials, say ASCO and Friends of Cancer Research

    People with cancer should be included in COVID-19 vaccine clinical trials, according to a new joint position statement from the American Society of Clinical Oncology (ASCO) and the Friends of Cancer Research (FCR).   “We’ve learned that patients with cancer are especially vulnerable to severe illness, hospitalization, or death due to COVID-19,” said ASCO President Everett E. Vokes in a joint press release announcing the position statement. “It is critically important...
  • 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...
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    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 ...
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    FDA panel split on approach to COVID-19 vaccines for younger children

    Members of the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) disagreed as to whether the agency should grant emergency use authorizations (EUAs) for COVID-19 vaccines for children at a 10 June meeting.   Some said that EUAs were necessary to get the pediatric population vaccinated quickly to achieve herd immunity as the country emerges from the pandemic and that these vaccines should be available soon as th...