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The alliance will add to Roche’s RNAi efforts, which include the hypertension candidate zilbesiran, partnered with Alnylam under a July 2023 agreement.
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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.”
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
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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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After the company’s investigational eye therapy recently failed two late-stage studies, Kodiak Sciences’ Chief Medical Officer and Chief Development Officer Jason Ehrlich has resigned from his roles.
The companies contend that their updated COVID-19 vaccines for the fall vaccination season can elicit strong immune responses against the virus’ currently dominant and emerging subvariants.
The company disclosed Thursday in a second-quarter report that it will continue advancing its chronic refractory gout treatment but is suspending further investments in its pipeline.
The German company on Thursday said it is launching three late-stage studies of its obesity drug candidate after the injectable showed up to 19% weight loss after 46 weeks in a mid-stage trial.
Some experts question the value of recently issued FDA guidance that aims to address gaps in the quality of unapproved laboratory tests for cancer.
After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.
Mifepristone’s legal saga continues as the U.S. 5th Circuit Court of Appeals ruled for steep restrictions on the drug’s access, though its effectivity is pending the Supreme Court’s review.
The company’s first-in-class small molecule imipridone, ONC201, showed strong efficacy results in two early-stage clinical trials of 71 pediatric patients with H3K27M-mutant diffuse midline gliomas.
The clinical trial testing Seagen’s tyrosine kinase inhibitor Tukysa, in combination with Genentech’s Kadcyla, met the primary endpoint of progression-free survival in HER-2 breast cancer patients.
The regulator informed bluebird bio that it will not convene an advisory committee meeting to discuss the company’s application for the gene therapy being developed for sickle cell disease.