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.
In its first markup of the 118th Congress May 2, the Senate Health, Education, Labor and Pensions (HELP) Committee, under the new leadership of Sen. Bernie Sanders (I-Vt.), devolved into a brief mutiny of sorts as the committee members started to take up four bipartisan bills aimed at taming prescription drug prices.
With its sights set on a series A and an IPO following a £3.5 million (US$4.4 million) investment round in 2021, Scottish biotech ILC Therapeutics Ltd. is hoping to make waves with a sublingual interferon antiviral to treat COVID-19. The USP for the company’s lead, Alfacyte, is the fact that it’s an artificial version of interferon, so it has less of a propensity to cause the flu-like symptoms that can come from treatment with natural kinds, which hike levels of cytokines and interleukins. As a hybrid interferon that is composed of interferon alpha-10 and interferon alpha-12, Alfacyte is “up to 10,000 times less likely” to cause adverse effects, according to ILC CEO Alan Walker.