While the FDA’s Center for Drug Evaluation and Research met all action dates for the 53 new molecular entities approved in 2020, despite the COVID-19 pandemic, developers of at least 8 drugs continue to wait for a decision beyond their expected timelines.
As the world begins to emerge from a horrific pandemic, it has become abundantly clear that dangerous infections are here to stay, and it is up to health care leaders and citizens to remain prepared and vigilant in preventing another deadly and disruptive COVID-19.
PERTH, Australia – The majority of medical device and biopharma industry respondents agreed that Australia’s Therapeutic Goods Administration (TGA) responded effectively to COVID-19, but they want to see the agency improve its processes to act faster and with more clarity, according to the TGA’s annual stakeholder survey.
A decade from now, 2020 likely will be considered a year like no other in terms of the massive amounts of capital raised amid a raging pandemic. Financing transactions of all types smashed records and in terms of volume hit 1,580, a total that was 42% higher than last year.
Thanks to the pandemic caused by the SARS-CoV-2 coronavirus identified in late December 2019, 2020 was the year of COVID-19. It was a year of lockdowns and social distancing, a year of Zoom meetings and virtual conferences, and a year when donning a face mask sometimes came to signify a political rather than health decision.
PERTH, Australia – Although Australians pay less for their drugs than patients in many other countries, Australia is falling behind when it comes to reimbursement for newer, targeted therapies, according to a report launched by Medicines Australia that assessed the timelines for registration and reimbursement of new medicines in Australia compared to 10 other Organisation for Economic Co-operation and Development (OECD) countries.
LONDON – The COVAX initiative, set up in a bid to ensure equitable distribution of COVID-19 vaccines, is poised for a global rollout starting in Q1 2021, after sealing agreements to access 2 billion doses of a number of different products. That puts the world on a clear pathway to ending the acute phase of the pandemic, by protecting the most vulnerable people around the world, according to GAVI, the vaccines alliance, which is spearheading COVAX.
NEW DELHI – India is taking a multipronged approach to developing and distributing vaccines against COVID-19, with at least 10 different products under development, domestically or through collaborations with foreign developers. Vaccinations are likely to begin early next year but, with a population of around 1.2 billion, it is unlikely India will be able to vaccinate everybody it needs to before the end of 2022.
Nothing much has changed since last month. This year is still, by far, the best year for financings in biopharma history, although the gap between 2020 and the next highest year has widened even more.