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  • Regulatory NewsRegulatory News

    Euro Convergence: Early consultation critical in overcoming gene therapy hurdles

    When it comes to advancing gene therapy products in the United States and Europe, the key is early consultation with regulators and identification of potential problems, experts said at the Euro Convergence 2020 virtual meeting. “It is better to do it earlier and establish a collaborative and educational approach to discussions,” advised Mridula Shukla, director of global regulatory affairs at Arcutis Biotherapeutics in Palo Alto, Calif.   Patrick Celis, PhD, head of ...
  • Regulatory NewsRegulatory News

    EMA outlines regulatory transparency measures amid COVID pandemic

    Reflecting the extraordinary circumstances of the pandemic, the European Medicines Agency (EMA) announced that the agency is speeding announcements regarding the progress of clinical trials of vaccines and therapeutics for COVID-19. The agency is also making public certain information about the progress of clinical trials that would not ordinarily be published.   To clarify how it is addressing transparency for COVID-19-related medicines, EMA published a table listin...
  • Regulatory NewsRegulatory News

    FDA revises REMS MAPP for new comparable ETASU provisions

    The US Food and Drug Administration (FDA) this week revised its manual of policies and procedures (MAPP) to reflect recent statutory changes that make it easier for drugmakers to develop separate risk evaluation and mitigation strategies (REMS) with comparable elements to assure safe use (ETASU).   The Further Consolidated Appropriations Act, 2020 , which was enacted late last year, included two provisions aimed at increasing generic and biosimilar competition.   ...
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    RAPS' virtual Euro Convergence 'provides needed forum' for European regulatory pros

    RAPS’ weeklong 2020 Euro Convergence wrapped up today, fittingly concluding with a session devoted to the impact of the COVID-19 pandemic on the future of regulatory. The profound effects of the pandemic have reached across myriad aspects of healthcare and regulation, forcing regulators and regulated industry to adapt and collaborate in new ways, streamline processes and work on accelerated timeframes.   Euro Convergence programming also had to adapt to suit this yea...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the  United Kingdom  and  Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in the United States ,  Japan  and Australia.   Convalescent plasma may be used in the US to treat hospitalized patients under an emergency use authorization (EUA) or an investigational new drug application (IND). “Adequate and well-controlled random...
  • ReconRecon

    Recon: Regeneron to stop enrolling sickest patients in COVID antibody trials; AZ sells rights to two drugs for $400M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Regeneron to stop enrolling very sick COVID-19 patients in antibody trials ( Reuters ) ( Endpoints ) Inside Operation Warp Speed’s $18 Billion Sprint for a Vaccine ( Bloomberg ) Biden’s policies could spell trouble for biotech — but industry CEOs are backing him anyway ( STAT ) AbbVie Reports Third-Quarter 2020 Financial Results ( Press ) Medtronic to Pay Ove...
  • Regulatory NewsRegulatory News

    PDUFA VII: FDA and industry set priorities in first round of negotiations

    After kicking off the Prescription Drug User Fee Act (PDUFA) reauthorization process in July, the US Food and Drug Administration (FDA) has released the first set of meeting summaries in its ongoing negotiations with industry that will shape its prescription drug review program from FY2023-2027.   The meeting summaries, while brief, provide insights into what FDA and industry hope to get out of the multi-billion-dollar agreement, with representatives from government ...
  • Regulatory NewsRegulatory News

    Lack of product-specific guidance slows ANDAs: FDA study

    Researchers at the US Food and Drug Administration (FDA) found that, for drugs that are new chemical entities, generic submissions were more likely when the reference brand-name drug generated more revenue.   Looking into other factors that predict that an abbreviated new drug application (ANDA) will be filed for a reference drug, the investigators also found that sponsors were less likely to file ANDAs for complex drugs.   In a retrospective study examining 400 br...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. The Herculean effort means that a fast-tracked vaccine could come to market anywhere from the  end of 2020  to the middle of  2021 .   To date, just two coronavirus vaccine has been  approved . Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamaleya Research Institute in Moscow – was approved by the Ministry of Health of th...
  • Regulatory NewsRegulatory News

    Euro Convergence: EMA makes case for multi-stakeholder response to emerging challenges

    The idea that regulatory agencies can come up with solutions in isolation is “very dangerous” and underscores the need for multi-stakeholder responses to emerging challenges, said Anthony Humphreys, of the European Medicines Agency (EMA), at the Euro Convergence 2020 virtual meeting.   Speaking during a session on supporting innovation, Humphreys, head of EMA’s regulatory science and innovation taskforce, set out the importance of gathering the views of other stakehold...
  • RoundupsRoundups

    Euro Roundup: MHRA shares post-Brexit assessment routes, variations guidances

    New guidances from the Medicines and Healthcare products Regulatory Agency (MHRA) address new assessment routes, marketing variation processes and rules on converting Community Marketing Authorisations (CAPs) that will apply to products sold in the United Kingdom post-Brexit.   The new assessment routes include an accelerated assessment pathway that, like its EMA equivalent, will reduce the regulatory review timeline to 150 days, according to the guidance.   The pa...
  • ReconRecon

    Recon: Novartis buys Vedere Bio for $150M upfront; Gilead reports $873M in remdesivir sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A P value of 0.38? NEJM results raise new questions for Eli Lilly's vaunted Covid antibody ( Endpoints ) ( NEJM ) Regeneron Covid-19 Therapy Reduces Viral Load, Need for Care ( Bloomberg ) ( Endpoints ) ( NBC ) Antibody drugs seem to work. But the virus is moving faster than we can make them ( STAT ) Moderna on track to report late-stage COVID-19 vaccine data ...