COVID-19’s impact after one year.
FDA policy experts Jesse Goodman, Mark McClellan, Peter Lurie, David Bowen, Patti Zettler, and Aaron Kesselheim suggest ideas and points to consider in using the COVID-19 experience to assess whether standards for EUAs should be adjusted.
The EU and the UK are going their own way when it comes to making COVID-19 vaccines and treatments available. The European Commission has chosen the full conditional marketing authorization path, while the UK, no longer a member of the EU, is taking the temporary authorization route.
Pandemic Perspectives: NCATS Director Urges Rare Disease Community To Push Against Return To Clinical Trial Status Quo
Chris Austin argued the rare disease community deserves the same “movement of heaven and earth” mentality as was employed for COVID-19.
In this edition of Device Week, Medtech Insight’s Reed Miller discusses some important news from Medtronic and Marion Webb reviews the first of two feature articles on the impact of the pandemic on the medtech industry around the world.
In a discussion with Medtech Insight, partners at Simon-Kucher & Partners explained that the pandemic has, and will continue to, transform both the sales and revenue models of medtech.
Pandemic Perspectives: Acacia CEO Says Pre-Existing Commercial Relationships, End-User Backing Key To Product Launches
Despite sector lockdowns there, Acacia has just launched two hospital-based products in the US. Its CEO Mike Bolinder tells Scrip how it defied the pandemic to get its drugs to their users.
From mRNA to subunit vaccines, Indian companies have 20 COVID-19 vaccine candidates, while three have already been approved. An August nod for Biological E could not just cut down time to immunize the country's population but also allow exports to resume.
From re-examining the FDA’s place in the broader US government to how fast and flexible it can be clearing therapies in non-emergency times, the COVID-19 EUA experience is expected to have a long-lasting impact on the agency.
Pandemic Perspectives: Shifting Research Realities After COVID-19 Place Decentralized Trials Center Stage
Agreeing that decentralized trials are here to stay, experts discussed in a recent meeting ways in which the pharma research landscape is set to change. With nearly 85% of the industry at different stages of adoption, such trials have seen greater traction in the US, while stricter data privacy laws have hampered progress in Europe, ISCR’s annual conference heard.
The US Food and Drug Administration's EUA pathway has seen more use in the therapeutic and vaccine space during the current pandemic than it has in its entire 16-year history and in many cases the potential eligible populations for the authorized products are far larger than past EUAs. Pink Sheet infographic compares details of past and present EUAs.
Preliminary data from IQVIA suggest 2020 was one of the weakest in recent years for new launch trajectories although drug companies tell Scrip there are some lessons learned from promoting during the pandemic.
Weaknesses in the global pharmaceutical supply chain, exposed and exacerbated by the coronavirus pandemic, have led major markets to pursue localization policies aimed at bolstering domestic production capacity. But any significant transformation promises to take many years.
In Part 2 of Scrip’s roundtable, execs from Athira, Cartesian, Cyclacel, Tonix and VOZ Advisors discuss how the pandemic brought in new investors and triggered strategic shifts for the biopharma industry.
The ways companies found to move forward during the challenging year also offer opportunities for industry to improve. During a roundtable discussion with Scrip, execs from Athira, Cartesian, Cyclacel, Tonix and VOZ Advisors weighed in on the adaptations they made and what changes they’ll stick with.
COVID-19 doesn't seem to be going away any time soon and antivirals remdesivir and favipiravir remain part of the treatment armamentarium. “Safety inventories” are in place for remdesivir in India, while a key physician anticipates an uptick in the use of favipiravir amid a surge in cases in some parts of the country.
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