Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ani, ARS, Bloomsbury Genetic Therapies, Byondis, Clearmind, Decibel, Hefei Tianhui, Immpact, Innovent, Lianbio, Novavax, Nuvectis, Oramend, Pyxis, Regeneron, Sisaf.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB, Astrazeneca, Biophytis, Chiesi, Eli Lilly, Hemogenyx, Lighthouse, Minerva, Protalix, Servier, Theravance.
By analyzing a cohort of adolescents that developed myocarditis or pericarditis after vaccination against SARS-CoV-2 vaccination, researchers from Yale University School of Medicine were able to pinpoint the underlying mechanism as an overly active innate immune response to the vaccine that led to broad activation of T cells and natural killer (NK) cells. Myocarditis “has been seen in other vaccine contexts, though is most common after viral infection,” Carrie Lucas told reporters at a press conference announcing the findings.
Even though COVID-19 is transitioning from pandemic to endemic across the world, it will remain first in mind as U.S. lawmakers look to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year to ensure the country is better prepared for future threats. With a Sept. 30 deadline for reauthorizing PAHPA, the Senate Health, Education, Labor and Pensions (HELP) Committee has its work cut out for it. But it won’t be starting from scratch. In opening a May 4 hearing on the reauthorization, HELP Chair Bernie Sanders (I-Vt.) said the committee would build on the efforts started last year under then-Chair Patty Murray (D-Wash.) and now-retired Ranking Member Richard Burr (R-N.C.).
Multivalent vaccines that could improve SARS-CoV-2 immunity while also preventing infections by other viruses, such as influenza and respiratory syncytial viruses, constitute an urgent public health need. Currently approved vaccines against SARS-CoV-2 are based solely on the spike protein, which provides limited immunity against variations in spike.
With the COVID-19 public health emergency ending in the U.S. next week, Congress is looking to use the lessons learned from the pandemic to draft a new iteration of the Pandemic and All-Hazards Preparedness Act to ensure the country is better prepared for the next pandemic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Gilead, Optinose, Regeneron, Sanofi, Tonix, Valeo, Vertex, Xortx.
The industry is not over the post-COVID-19 funding crash, and as the dust settles there are mixed signs for future prospects, with some metrics in decline, others more or less back to pre-pandemic levels, and some showing signs of improvement. But on the key productivity metric, there is a downward trend, with fewer new molecular entities (NMEs) approved by both the U.S. FDA and EMA over the last year and a half.