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Eli Lilly is picking up Ajax Therapeutics and its once-daily oral blood cancer candidate. The deal follows the pharma’s buyouts of ADC specialist CrossBridge Bio and in vivo CAR T company Kelonia Therapeutics.
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The FDA is signaling change, but actual success depends on more than simply bringing in a new leader at the Center for Biologics Evaluation and Research; it requires accountability, transparency and consistent action.
Approved Thursday via the FDA’s Commissioner’s National Priority Voucher program, Otarmeni is the first gene therapy for hearing loss—and the first treatment to target an underlying cause of the condition.
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Doubling survival in pancreatic cancer, a long-fought rare disease approval, a massive IPO and ambitious biotech entrepreneurs have BioSpace Senior Editor Annalee Armstrong feeling upbeat about the biotech scene.
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During the pharma earnings season, which begins on Tuesday, Novo Nordisk will report the first revenue numbers from an oral GLP-1 medicine, while other companies are expected to address the FDA, drug pricing and Trump’s new tariffs.
The FDA has greenlit Travere Therapeutics’ Filspari as the only available treatment for focal segmental glomerulosclerosis despite the drug’s loss to Sanofi’s Avapro in a Phase 3 study.
Some 30% of clinical trials that are mandated to report their findings have not posted results to clinicaltrials.gov, the federal government’s public repository for studies, according to internal data from the FDA.
Bringing patients into the drug development process early has proven to save time, money and resources.
Trastuzumab pamirtecan, being developed under a 2023 partnership between BioNTech and DualityBio, elicited a 44.1% overall response rate in a Phase 2 trial.
Almost half of the top 100 medicines vulnerable to supply disruptions in the U.S. have at least one key starting material with a single source country, according to a new report from United States Pharmacopeia.
Pivotal findings for the off-the-shelf cell therapy surpassed William Blair’s expectations and sent Allogene Therapeutics’ stock up more than 50% in pre-market trading Monday morning.
In a difficult disease, Revolution Medicines achieved what the pancreatic cancer community has long desired: a significant improvement in survival. The Phase 3 results will support global regulatory filings.
Darovasertib, in combination with crizotinib, more than doubled progression-free survival in a registrational trial, leading Truist analysts to declare a “best-in-class efficacy profile” for the PKC inhibitor.
The licensing deal marks AbbVie’s first foray into new pain medicines, a space where Vertex currently enjoys a lead thanks to the NaV1.8 inhibitor Journavx.