• TrackersTrackers

    COVID-19 therapeutics tracker

    More than a year into the pandemic, only 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 antibodies bamlanivimab with etesevimab as well as Regeneron’...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. More than 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 ...
  • Regulatory NewsRegulatory News

    New toolbox available for EMA's PRIME designees

    The European Medicines Agency has released a draft guidance to assist drug developers using its Priority Medicines (PRIME) scheme to accelerate authorization of new therapies.   “Experience to date has shown that applicants face challenges to complete quality and manufacturing development and data requirements during development of products in early access approaches,” wrote EMA in the executive summary of the guidance.   Challenges for those developing breakthroug...
  • Regulatory NewsRegulatory News

    EMA's CHMP gives Gamifant a second thumbs down; approves five new medicines

    In its November meeting, a committee of the European Medicines Agency gave its second thumbs down to the monoclonal antibody Gamifant (emapalumab), confirming a July 2020 negative opinion on the Novimmune SA drug.   The US FDA approved Gamifant for pediatric use in primary hemophagocytic lymphohistiocytosis in November 2018; this was the same indication for which EMA has twice declined authorization.   EMA’s human medicines committee (CHMP) had positive recommendat...
  • Regulatory NewsRegulatory News

    FDA, EC offer guidance on COVID-19 convalescent plasma

    The US Food and Drug Administration (FDA) and European Commission (EC) recently released guidance on convalescent plasma collected from individuals who have recovered from COVID-19 and which may potentially be used as a treatment for COVID-19. FDA’s 9-page guidance, which follows the agency’s granting of the use of single patient emergency Investigational New Drug Applications (eINDs) to the investigational plasma, is meant to provide recommendations to health care pr...
  • RAPS' LatestRAPS' Latest

    Hear from the experts who wrote the book

    RAPS has introduced a new, comprehensive resource that promises to find a secure place on every regulatory professional’s bookshelf. Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition , spans 18 chapters with updates from more than 30 leading regulatory experts. Topics range from why it is no longer enough for today’s regulatory professional to just focus on regulatory guidance, to a primer on regulatory intelligence, to defining regulatory strategies...
  • Regulatory NewsRegulatory News

    Belgium Inspects Companies Delaying or Preventing Biosimilar Competition

    The Belgian Competition Authority (BCA) said recently that it’s inspecting the premises of companies suspected of using restrictive practices to limit, delay or prevent the entry of biosimilar competition. While the authority did not offer any details into what companies are being inspected, the authority did say that this is a preliminary step into its investigation of such restrictive practices. “Conducting inspections does not prejudge the outcome of the investiga...
  • Regulatory NewsRegulatory News

    Will Some Biologics Get 30 Years of Exclusivity?

    As the wrangling over the US-Mexico-Canada trade agreement continues, a provision to require Mexico and Canada to accept 10 years of biologic exclusivity stirred up controversy because it would be two more years than what Canada currently enjoys and add five more years for Mexico. In the US, biologic exclusivity is set at 12 years. But in reality, a 30-year run for a biologic without competition is possible, following a court win for Amgen last August. And 15-plus y...
  • Regulatory NewsRegulatory News

    Here Come the Oncology Biosimilars in the US: How Low Will Prices Go?

    A quick look at biopharma’s top-selling drugs (including forecasted sales through 2024) reveals a trio of biologic cancer treatments that have been marketed since 1997 and will likely bring in a cumulative total of more than $300 billion. But biosimilar competition for Roche’s Herceptin (trastuzumab), Avastin (bevacizumab) and Rituxan (rituximab) is now ready to launch in the US, and Bernstein biopharma analyst Ronny Gal said in a report issued Friday that prices over...
  • Regulatory NewsRegulatory News

    FDA Releases New Data to Help Generic Drug Competitors

    Generic drug applicants will now have more information from the US Food and Drug Administration (FDA) when deciding whether to file a generic drug application, which could potentially increase the odds of earlier approvals, the agency said on Tuesday. Previously, FDA’s Paragraph IV Patent Certifications List included only the name of the drug (along with the dosage form and strength) and the date on which the first substantially complete generic drug application that ...
  • Regulatory NewsRegulatory News

    700% Price Spike Spurs UK to Allege Four Pharma Companies Agreed to Restrict Competition

    The UK’s Competition and Markets Authority (CMA) on Thursday alleged that Focus Pharmaceuticals, Medreich, Alliance Pharmaceuticals and Lexon have breached UK and EU law by entering into anti-competitive agreements that restricted the supply of the nausea and dizziness drug prochlorperazine. Under two alleged agreements discovered by CMA, Alliance Pharmaceuticals supplied prochlorperazine exclusively to Focus Pharmaceuticals. And Focus paid Lexon a share of the profits ...
  • Regulatory NewsRegulatory News

    European Commission Focuses New Report on Pharma Competition Enforcement

    The European Commission (EC) on Monday released a report on pharmaceutical competition enforcement activities by the Commission and EU member states' national competition authorities from 2009 to 2017.   The 46-page report was put together in response to concerns voiced by the European Council and Parliament in 2016 and 2017 regarding anticompetitive practices within the pharmaceutical sector, such as tactics to delay generic competition, pay-for-delay arrangements...