Wish to keep on prime of the science and politics driving biotech at present? Enroll to get our biotech e-newsletter in your inbox.
Morning. As we speak, we’ve got a brand new biotech scorecard, which lays out the following quarter’s value of the sector’s anticipated stock-moving occasions. Additionally, we see the Trump administration’s transition on the FDA taking form, and extra.
A biotech scorecard for the primary quarter
Every quarter, STAT’s Adam Feuerstein outlines among the most noteworthy biotech occasions more likely to transfer shares. This quarter, there’s lots to be careful for, together with an interim Section 3 evaluation from Ultragenyx on its osteogenesis imperfecta antibody drug setrusumab, and one other from Praxis Precision Medicines on its experimental drug ulixacaltamide, which it’s testing for important tremor.
Comapnies similar to Incyte, Protagonist Therapeutics, and Strong Biosciences are additionally nearing vital trial outcomes and Kura Oncology could quickly be prepared for a advertising and marketing utility. A number of PDUFA dates are developing as properly. The FDA will decide about medicine together with suzetrigine, made by Vertex Prescribed drugs, which is a non-opioid strategy to acute post-surgical ache.
Learn extra.
Trump’s FDA transition plan takes form
The Trump administration is forming its FDA transition plan, STAT’s Rachel Cohrs Zhang reviews. Figures together with Lowell Zeta, a former senior counselor to ex-FDA Commissioner Stephen Zahn, and Jim Traficant, CEO of communications agency Pinkston Technique, are aiding with outreach and recruitment efforts.
The group is working with Grace Graham, a distinguished Capitol Hill well being coverage professional, about probably taking up a big position on the FDA. Trump has mentioned he’ll nominate Marty Makary, a surgeon at Johns Hopkins, to be his FDA commissioner.
Learn extra.
Eli Lilly seeks to hitch lawsuit on compounded medicine
From STAT’s Elaine Chen: For a number of months now, a compounding commerce group has been engaged in litigation towards the FDA over the company’s declaration that Eli Lilly’s tirzepatide (aka Mounjaro/Zepbound) is now not in scarcity. Lilly now needs to hitch the lawsuit as a defendant, to “defend its pursuits and assist carry this go well with to a swift finish,” in line with a authorized submitting final week.
For background, the FDA in October pulled tirzepatide of its scarcity listing after nearly two years. Compounders are allowed to make copies of branded medicine solely when the remedies are on the listing. The commerce group, known as the Outsourcing Services Affiliation, sued the FDA, arguing that the scarcity wasn’t really over. The FDA took a while to rethink its determination and final month re-affirmed that tirzepatide ought to certainly be off the scarcity listing.
Lilly, in its authorized submitting, argues that the place of the compounding group “straight impacts Lilly’s pursuits in preserving its unique proper to promote its FDA-approved medicines.” The FDA, as a authorities company “is not going to ’adequately symbolize [Lilly’s] curiosity[s],’” the submitting mentioned.
That is the most recent transfer in Lilly’s long-standing marketing campaign towards compounders. Its executives have mentioned that compounded merchandise aren’t protected and that the expansion of compounding may create a “backdoor generic world.”
Biden grants highest U.S. award in science, tech
President Biden has acknowledged numerous people for his or her contributions to science and expertise with the nation’s highest award. CRISPR scientists together with Jennifer Doudna and Feng Zhang received the Nationwide Medal of Know-how and Innovation, as did the businesses Moderna and Pfizer, every of which developed mRNA vaccines of vital significance throughout the Covid-19 pandemic.
Among the many Nationwide Medal of Science recipients had been MIT supplies scientist Angela Belcher, who has used genetically modified viruses to construct batteries and most cancers therapies, and stem cell biologist Helen Blau of Stanford, who works on tissue regeneration expertise.
Extra reads
Novo asks FDA to limit Victoza compounding amid GLP-1 outsourcing row, FierceBiotech
GSK’s Nucala luggage one other China approval, however greatest check but to come back, Endpoints
