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In its 2025 full year and fourth-quarter earnings call, Merck executives touted the merits of recent deals and what CEO Robert Davis called “probably the broadest and widest pipeline we’ve had in years.”
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After suffering in the wake of expired tax incentives for pharmas, the island is trying to take advantage of geopolitics to grow its drug manufacturing sector.
AstraZeneca’s $15 billion pledge to its China operations highlights the country’s advantages. But other regions are also hoping to host more clinical studies.
With Lykos’ regulatory failure now squarely in the rearview mirror, Compass Pathways and Definium are leading what one analyst suspects will be “a very big year for psychedelics.”
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Phacilitate’s annual event dawns as cell and gene therapies reach a new tipping point: the science has hit new heights just as regulatory and government policies spark momentum and frustration.
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FDA
Pfizer, Moderna, Novavax and more are working to combine preventative shots for COVID-19, flu, RSV and other illnesses. Will convenience be enough to overcome vaccine fatigue?
Here’s how expanding companies can benefit from executive-level strategic experience in key areas while staying lean and nimble.
In its third-quarter results Tuesday, Amgen announced a $650 million write-down after discontinuing AMG 340, a prostate cancer candidate acquired in the $900 million buy of Tenobio in 2021.
Following the recent Chinook Therapeutics acquisition, the Novartis experimental IgA nephropathy therapeutic atrasentan significantly reduced protein in the urine of patients compared to placebo.
Despite failing to hit the primary endpoint in the Phase III EMBARK study, the company plans to file for a label expansion for its Duchenne muscular dystrophy gene therapy Elevidys.
More and more companies are turning to artificial intelligence for drug safety prediction, but as with any new application of AI, experts urge caution.
FDA
Loqtorzi is the first programmed death receptor-1 from China to be approved by the U.S. regulator, and the first for patients with recurrent or metastatic nasopharyngeal carcinoma across all lines of treatment.
In a briefing document for Tuesday’s advisory committee meeting, the FDA raised concerns about the potential off-target effects of Vertex Pharmaceuticals and CRISPR Therapeutics’ investigational gene edited therapy.
The Japanese pharma’s attention deficit/hyperactivity disorder candidate has shown significant symptom improvements in children and adolescents in two late-stage studies.
Merck and Novartis beat expectations this week with solid third-quarter financial results, while BMS, Sanofi and Takeda spooked investors with negative near- and mid-term projections.