Amid speculation that the White House had killed it, the FDA issued a promised guidance Oct. 6 on what it will take to get an emergency use authorization (EUA) for a COVID-19 vaccine.
New data from a global phase II trial of Kiniksa Pharmaceuticals Ltd.'s monoclonal antibody, mavrilimumab, in the rare chronic inflammatory disease giant cell arteritis showed a 62% lower risk of flare in patients receiving the candidate vs. those given a placebo.
HONG KONG – Cambridge, U.K.-based Astrazeneca plc has resumed phase I/II trials in Japan for AZD-1222, the experimental, adenovirus vector-based candidate coronavirus vaccine that it is co-developing with the University of Oxford.
Just as financings are hitting record levels, biopharma deals should finish out 2020 on top, based on solid partnerships signed in the first three quarters of the year. While mergers and acquisitions have slowed this year, particularly in the third quarter, several big-money M&As slated to close in the fourth quarter could move the needle, putting this year within the top three highest values.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aegle, Amag, Amphastar, Biogen, Biontech, Curtana, Glycomimetics, Huya, Iovance, Oncternal, Oragenics, Pfizer, Samsung, Y-mabs.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA’s PRV fees drop again; PMDA offering early COVID-19 vaccine advice; NICE, SIGN go long on COVID-19.
What is the future of med-tech innovation in the wake of COVID-19? That was the question addressed during the Advanced Medical Technology Association’s Virtual Medtech Conference, with members of industry providing some insight. “I think … that this is going to be in many ways a turning point,” changing the way stakeholders look at devices and the evidence supporting them, said Tom O’Brien, of Johnson & Johnson’s (J&J) Ethicon unit.
In a fireside chat at the Advanced Medical Technology Association (Advamed)-sponsored Virtual Medtech Conference on Oct. 5, U.S. FDA Commissioner Stephen Hahn addressed questions that have been circulating for months about the political pressure that the agency is facing to quickly approve a vaccine for COVID-19 by reiterating that any decisions will be “completely dependent on when data is mature” from phase III trials.
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