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With data from a mid-stage trial showing weight loss of up to 12.3% at 28 weeks in patients treated with PF’3944, “Pfizer is moving full speed into obesity clinical development,” BMO Capital Markets said Tuesday.
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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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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.
Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.
Following injection site reactions in a Phase I study, the company is developing a new formulation for its Friedreich’s ataxia candidate setting the asset’s clinical progress back significantly.
The company is ending its investigational drug GB0139’s run in idiopathic pulmonary fibrosis after the small-molecule inhibitor failed to slow lung function decline in a Phase IIb study.
Following its Scorpion Capital controversy in March, Harmony Biosciences is seeking to deepen its pipeline with an acquisition of Zynerba Pharmaceuticals’ cannabinoid therapies for neuropsychiatric disorders.
On the heels of J&J’s Talvey, Pfizer’s bispecific antibody Elrexfio has secured an accelerated approval as another off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma.
The legal complaint, filed with the Scripps Research Institute, alleges that Dexcel Pharma Technologies’ plan to sell a generic version of Pfizer’s Vyndamax (tafamidis) infringes on three patents.
Valneva’s chikungunya vaccine candidate will have to wait three more months for a decision from the regulator, potentially giving rival Bavarian Nordic additional time to catch up.
J&J’s Janssen Pharmaceutical got the FDA’s greenlight Friday for its PARP inhibitor Akeega, which is now authorized to treat BRCA-mutated metastatic castration-resistant prostate cancer.