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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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While Sage Therapeutics’ drug candidate showed a slight difference compared to placebo in a mid-stage Huntington’s disease trial, William Blair analysts in a Tuesday note to investors said they “remain cautious” on dalzanemdor and “do not view the small numerical changes as definitive.”
Despite a surge in the financial markets, multiple Big Pharma companies have announced hundreds or even thousands of cuts. Experts hope for a better second half of the year.
Seeking to carve out its own niche in the obesity space, Syntis Bio launched on Tuesday to develop an oral weight-loss treatment that mimics the effects of gastric bypass surgery.
On Monday, GSK reported that a plaintiff voluntarily dropped her Zantac case against the company and that it is in the process of appealing a Delaware State Court’s decision to admit expert testimony in other cases.
More patients are having to pay out-of-pocket for Eli Lilly’s weight-loss medication Zepbound than they did for type 2 diabetes drug Mounjaro, according to Lilly USA President Patrik Jonsson.
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Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.
The House Select Committee asks the FBI for a briefing on GenScript’s links to China, fueling the challenge facing public relations and investor relations teams at US biopharma firms and Chinese CDMOs.
Given their seven-figure price tags, it’s not clear how accessible the would-be cures will be to U.S. patients on public or private insurance.
Despite concerns raised in FDA briefing documents about Eli Lilly’s Alzheimer’s treatment, donanemab, the committee concluded that the benefits outweighed the risks.
In an SEC filing on Friday, Alumis said it aims to start late-stage trials of a TYK2 inhibitor in plaque psoriasis this year and is seeking public funding for the studies.