• TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. A handful of vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker now 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 e...
  • 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.   Three therapeutics have received emergency use authorizations (EUAs) in the US. Convalescent plasma, which was authorized by the Food and Drug Administration (FDA) on 23 August and is subject to updated...
  • 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

    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 Rolls Out Expectations for Biosimilars, Soon-to-Be Biologics

    The US Food and Drug Administration (FDA) on Tuesday released two new draft Q&A guidance documents on biosimilar development and the deemed to be a license provision of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), as well as two final guidance documents on the same topics and one proposed rule amending the definition of a biological product. The efforts are part of FDA’s decade-long work to begin, starting in March 2020, transitioning the approved...
  • Regulatory NewsRegulatory News

    Biosimilars in the EU: New IMS Report Shows Savings Through Competition

    A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low. The report looks at the six classes of medicines in which biosimilars are approved, including epoetin, granulocyte-colony stimulating factor, human growth hormone (HGH), anti-tumor necrosis factor (anti-TNF), fertility and insulin products. With 28 biosimilar approvals, the EU i...
  • Regulatory NewsRegulatory News

    Non-Proprietary Naming of Biologics and Biosimilars: FDA Finalizes Guidance

    In a departure from the way the WHO and Europe name biologics, the US Food and Drug Administration (FDA) on Thursday finalized long-awaited guidance on how biosimilars and their biologic reference products’ names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name. The decision to finalize this guidance follows not only several tweaks (including one that has companies submit 10 suffixes to FDA for consideratio...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Maps International Regulatory Coordination (12 January 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Maps International Regulatory Coordination Initiatives to Show Overlaps, Gaps The European Medicines Agency (EMA) has mapped cooperative regulatory initiatives to better understand how and where international peers are working together. EMA found there were a “myriad of initiatives but no strategic coordination,” prompting it to warn regulators are duplicating effo...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Risk-Based Approach to Biologic Licenses, Ending Mandatory Inspections The Drug Controller General of India (DCGI) has scrapped the need for manufacturers to undergo a joint inspection before receiving certain biologics licenses. Instead of conducting pre-approval visits, Indian regulators will award Form 29 licenses within three days of receiving applications ...