• Regulatory NewsRegulatory News

    FDA "rapidly" finalizing EUA for J&J vaccine, following adcomm thumbs up

    In a unanimous vote, an advisory committee to the US Food and Drug Administration (FDA) has recommended authorization of the COVID-19 vaccine developed by Janssen, a division of Johnson & Johnson.   The 22-0 vote endorsing a favorable benefit-risk profile for the vaccine represents the third positive decision on a COVID-19 vaccine – but the first unanimous one – from FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC). In a statement that came...
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    MHRA awards first ‘innovation passport’ under new pathway

    Merck’s investigational drug belzutifan on Friday became the first drug to be awarded an “innovation passport” under the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) innovative licensing and access pathway (ILAP).   Belzutifan is being developed to treat adults with von Hippel-Lindau disease, a rare cancer-causing genetic disorder, and has been granted orphan designation in the EU and both orphan designation and breakthrough therapy designation b...
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    CHMP’s February recommendations: Evrysdi, Jemperli, and a generic for prostate cancer

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA’s CHMP) recommended six new medicines for approval when it met in February, including two biosimilars and one generic medicine.   The committee recommended marketing authorization for Roche’s Evrysdi (risdiplam) for the treatment of certain types of spinal muscular atrophy (SMA). It is the first oral treatment for this condition and was reviewed under the EMA’s accelerated assessment pr...
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    EU MDR survey: Time investment, costs, and personnel resources

    In 2020, a survey was conducted among medical device manufacturers to assess the true costs of the EU Medical Device Regulation for companies. The results show that the regulation requires considerable resources on the part of manufacturers in terms of time, costs, and personnel. Almost half the respondents said they believed the regulation would cost more than 5% of their annual turnover. However, most still relied on manual processes for their clinical data capture activ...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Almost a year into the pandemic, a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibody bamlanivimab alone and in combination with etesevimab as wel...
  • ReconRecon

    Recon: FDA approves Sarepta’s third DMD drug; Health Canada authorizes AstraZeneca vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA advisory panel to review Johnson & Johnson COVID-19 vaccine with thumbs up expected ( Reuters ) ( STAT ) ( FT ) During COVID-19, FDA’s Vaccine Advisory Committee Has Worked To Boost Public Trust – It Can Still Do More ( Health Affairs ) Sarepta wins new drug approval for patients with Duchenne muscular dystrophy, its third marketed treatment ( STAT ) ( Endp...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. A dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in early deve...
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    EMA releases guidance for COVID variant vaccine development

    The European Medicines Agency (EMA) has published a reflection paper laying out what data are needed to support approval of vaccines that protect against variants of SARS-CoV-2, the virus that causes COVID-19.   “[I]t is an urgent public health priority to define an expedited regulatory process for the adaptation of vaccines to protect against current or future variants,” wrote the agency in announcing the new guidance. The document comes less than 2 weeks after a vari...
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    FDA eases storage, transportation conditions for Pfizer-BioNTech vaccine

    The US Food and Drug Administration (FDA) on Thursday updated the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 vaccine to allow the vaccine to be transported and stored at temperatures found in conventional pharmaceutical freezers for up to two weeks.   The announcement comes one week after Pfizer and BioNTech disclosed they had submitted data demonstrating their vaccine’s stability at higher temperatures based on manufacturing data from the p...
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    England and Canada diverge from US on cancer drug decisions

    Regulatory and health technology assessment agencies in Canada and England are diverging from the US when it comes to oncology drugs. But they often rely on the same surrogate endpoints to make their decisions, according to two new analyses published in JAMA Internal Medicine .   The first study , led by Avi Cherla, MSc, of the London School of Economics and Political Science, revealed that among 68 cancer indications with accelerated approval in the US that also rec...
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    Tools for updating the IVDR template for demonstrating scientific validity

    In vitro diagnostic (IVD) testing has risen to meet the new EU regulations in the face of the significant pressures to achieve and perform adequately during the prevailing global adversity. That means existing templates must be structured to meet the new requirements of the In Vitro Diagnostic Regulation (IVDR) and demonstrate compliance with the general safety and performance requirements in Annex I of Regulation (EU) 2017/746. 1   The World Health Organization’s Glo...
  • ReconRecon

    Recon: Merck to buy Pandion Therapeutics for $1.85B; Bahrain authorizes J&J vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democratic opposition could sink Woodcock’s chances to be nominated as permanent FDA commissioner ( BioCentury ) ( Pink Sheet ) ( Endpoints ) Pfizer-BioNTech testing booster of their COVID-19 vaccine in new trial ( Reuters ) ( NBC ) Moderna expects $18.4 billion in COVID-19 vaccine sales in 2021 ( Reuters ) ( FT ) Moderna produces Covid-19 shot targeting varia...