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Speaking to BioSpace at the J.P. Morgan Healthcare Conference, Novartis’ chief dealmaker Ronny Gal explains why the Swiss pharma hasn’t acquired a GLP-1, and why it probably won’t.
There hasn’t been a headline-stealing deal at J.P. Morgan yet. Nevertheless, the mood is positive amid green shoots and a flurry of dealmaking to end 2025.
Acadia Pharma’s Catherine Owen Adams has formed a group of small- to mid-cap biotechs to advocate against a ‘peanut butter blanket’ approach to drug pricing for small companies.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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The UCSF professor and frequent YouTube poster has criticized COVID-19 vaccine mandates as well as the accelerated approval pathway and other FDA practices. Predictions of what his tenure might achieve are scattershot.
The Massachusetts biotech will focus its efforts and resources into cemsidomide, an oral drug candidate being trialed for multiple myeloma and non-Hodgkin lymphoma.
Although the job market did not pick up in April, layoffs were down year over year and month over month, according to BioSpace tallies. Meanwhile, Amgen, Novartis, Regeneron and Roche announced U.S. manufacturing investments that are sparking job creation.
Yes, according to leading vaccine physician Paul Offit, who denounced the new placebo-controlled trial requirements for vaccines and sought greater clarity: “I don’t know what they’re talking about.”
CRISPR Therapeutics’ partner Vertex reported that more than 65 treatment centers have been activated for the gene therapy Casgevy. While Vertex handles the market, CRISPR has been focused on its clinical program.
The FDA in February formally declared the end of the semaglutide shortage, which Novo Nordisk expects will help improve the market position of Wegovy. But Eli Lilly’s Zepbound is quickly gaining ground, with sales just $300 million behind Wegovy in Q1.
MassBio’s new report outlines several concerns, including NIH cuts undermining the research engine, FDA reductions delaying innovation and trade barriers disrupting supply chains.
Imports of pharmaceutical products surged in March, most of which came from Ireland, historically one of the biggest exporters of medicines to the U.S.
A new executive order aims to smooth the path for getting U.S. manufacturing facilities up and running; HHS says it will require placebo-controlled trials for all vaccine approvals; tariff threats hit BioNTech; Novo Nordisk’s FDA application for an oral version of Wegovy is accepted; and more.
Keytruda is set to lose exclusivity in 2028, meaning Summit may face competition from cheaper biosimilars. Meanwhile, other branded drugmakers are also seeking to improve on the blockbuster checkpoint inhibitor.