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While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
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Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for a controversial psychedelic long sidelined by safety concerns.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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The FDA’s priority review acceptance of BridgeBio’s BBP-418 is another step toward what William Blair previously dubbed a “diversified commercial portfolio.” It also adds to the rapidly building momentum in muscular dystrophy more broadly.
Apogee’s pipeline in a product drug zumilokibart achieved significant disease clearance in a mid-stage atopic dermatitis trial, but investors were miffed by a royalty financing deal with Blackstone.
FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
The FDA will convene its vaccines advisory panel to discuss seasonal COVID-19 vaccines—a surprise move after Health Secretary and vaccine skeptic Robert F. Kennedy, Jr. overhauled a separate vaccine committee.
An FDA advisory committee recently voted against approving AstraZeneca’s oral SERD drug camizestrant for certain patients with advanced breast cancer. It is unclear when the new target action date for the drug will be.
Nearly 80% of patients saw tumor shrinkage after being treated with Kura Oncology’s darlifarnib plus Bristol Myers Squibb’s Krazati, findings Mizuho analysts say could open up a $2 billion opportunity for the biotech.
Under the temporary reign of top food executive Kyle Diamantas, the FDA will sustain programs initiated by former Commissioner Marty Makary, including the Commissioner’s National Priority Voucher initiative.
Eli Lilly continues to spend its GLP-1 landfall with four new deals in the past week, including three in the vaccine space; the obesity leader also touted surgery-like results for its next-gen weight loss drug; Moderna’s stock climbs on the hantavirus “fear trade”; and in oncology, all eyes are on Revolution at ASCO this week.
The people most trusted to deliver are not always the ones invited to shape direction. Executive coach Angela Justice examines why the habits that build a career can eventually limit advancement.
Strong science and early support are not enough on their own. Europe needs more capital depth, cross-border investor backing and a lighter policy framework to keep companies scaling at home, according to two venture capitalists.