In an informative synthesis, we present key updates from the Food and Drug Administration, Profluent, as well as Novartis, Innovent Biologics, and Flagship Pioneering that may have eluded your attention.
The Food and Drug Administration has introduced a novel pilot initiative aimed at expediting communications with pharmaceutical companies post-formal meetings. This program grants companies the latitude to submit an email inquiry to agency personnel seeking “quick clarifications” on specific matters.
The FDA commits to delivering a response within three business days. Although initially confined to the Office of New Drugs, there are ambitions for broader implementation.
Commissioner Martin Makary remarked, “Numerous drug developers have communicated that a prompt touchpoint or clarification with the FDA team could avert months of uncertainty.” — Ben Fidler
Novartis has revised its sales forecasts for two flagship medications and unveiled plans to broaden its manufacturing base in North Carolina.
On Thursday, the pharmaceutical powerhouse increased projections for its leukemia treatment, Scemblix, and the breast cancer medication Kisqali, which are anticipated to exceed a combined annual peak of $14 billion.
The prior day, Novartis announced it would construct three new facilities in North Carolina, focusing on biologics, tablets, sterile packaging, and other offerings. This initiative is part of Novartis’s $23 billion commitment to U.S. pharmaceutical manufacturing made earlier this year. — Ben Fidler
Bezos Expeditions, the private investment arm of Jeff Bezos, has partnered with a consortium of investors to inject $106 million into AI-centric startup Profluent.
Announced on Wednesday, Profluent intends to allocate these funds towards generative AI frameworks designed to engineer novel proteins, which could lead to innovative pharmaceuticals or enhanced agricultural yields.
Profluent’s “Protein Atlas” has successfully generated over 115 billion distinctive proteins, claiming to offer the world’s largest data repository of its kind. According to a Forbes report, the startup is valued at nearly $1 billion. — Ben Fidler
An investigational obesity treatment, co-developed by Innovent Biologics and Eli Lilly, is advancing towards regulatory submission in China.
Innovent disclosed on Wednesday that the medication, which activates the gut hormones GLP-1 and glucagon, achieved all primary and key secondary objectives in a Phase 3 trial, demonstrating approximately 19% weight reduction over 60 weeks in adults with obesity, contrasted with a mere 3% in placebo participants.
The company stated they will submit an application for approval of the drug, named mazdutide, “in the near term.” Their collaboration spans multiple pharmaceuticals over recent years, and in 2019, mazdutide was included in their alliance. — Ben Fidler
Flagship Pioneering announced significant advancements on Thursday related to a 2024 collaboration with GSK, unveiling new agreements between the pharmaceutical giant and its startups ProFound Therapeutics and Quotient Therapeutics.
ProFound will assist GSK in discovering therapies targeting chronic obstructive pulmonary disease and idiopathic pulmonary fibrosis. Quotient, conversely, will identify drug targets for these conditions as well as metabolic dysfunction-associated steatohepatitis.
Should GSK decide to proceed, both startups will manage critical preclinical tasks, after which the multinational can opt to escalate initiatives into human trials. The partnership forged last year allowed GSK to explore up to 10 novel medicines or vaccines from Flagship’s portfolio of startups. — Gwendolyn Wu
Source link: Biopharmadive.com.
