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    COVID-19 therapeutics tracker

    As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19.   To date, three therapeutics are approved to treat COVID-19: dexamethasone in the  United Kingdom ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan .   Potential therapies are being...
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    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. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   The pandemic has created unprecedented public/private partnerships.  Operation Warp Speed  (OWS) is a collaboration of several US ...
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    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...
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    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...
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    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...
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    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...
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    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...
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    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...
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    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...
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    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...
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    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 ...
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    Arizona Becomes 21st State to Pass a Law Restricting Biosimilar Substitution at Pharmacies

    Arizona Gov. Doug Ducey (R) late last week signed into law a bill that would restrict which types of biosimilars pharmacists in the state can substitute biologics for. Hailed as a victory by industry group BIO , the law, like the 20 similar laws passed before it , is helping to create a patchwork of regulations governing how biosimilars are dispensed, even before biosimilars have hit the market en masse in the US. In the EU, however, the uptake of biosimilars, much l...