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With second-generation antibody-drug conjugates, Eli Lilly, Daiichi Sankyo and others look to reduce toxicity and improve the magnitude and duration of response.
FEATURED STORIES
Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
Job Trends
Lineage Cell Therapeutics, Inc., announced that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Roche and Genentech for the development and commercialization of a retinal pigment epithelium cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration with geographic atrophy.
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Read our takes on the biggest stories happening in the industry.
After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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The regulator approved Xacduro for treating hospital-acquired and ventilator-associated bacterial pneumonia. The NDA was filed by Entasis Therapeutics, which Innoviva acquired in 2022.
Despite a disappointing showing in the Phase III MOVE-FA trial, PTC Therapeutics says it will move forward with regulatory talks for the Friedreich’s ataxia treatment. Meanwhile, the company is discontinuing several early-stage gene therapies and reducing its headcount.
While the exact settlement details are confidential, the deal will allow Amgen to launch its Stelara biosimilar no later than January 1, 2025.
The Massachusetts-based company has claimed the year’s largest fundraise so far and secured a powerhouse R&D partner in Novo Nordisk to develop gene editing medicines.
The Massachusetts-based startup’s goal is to develop RNA medicines that can treat diseases anywhere in the body using an “all-in-one” platform.
The Swiss pharma has canceled a second mid-stage trial for its investigational schizophrenia drug ralmitaront, as the competition shows promise in the space.
With the FDA’s approval on Monday, Ayvakit is the first and only treatment for adults with indolent systemic mastocytosis, a rare hematologic disorder, according to Blueprint Medicines.
Indivior’s Opvee is an emergency nasal spray medication to reverse opioid overdose approved for patients aged 12 years and above with signs of respiratory or central nervous system depression.
Ex-FDA Neuroscience Director Billy Dunn was appointed to Prothena’s board of directors last week. Industry representatives and regulatory experts weigh in on the potential ethical implications.
Data from a Phase III trial of apraglutide for a type of short bowel syndrome with intestinal failure is expected by the end of the year. It is also in a Phase II study for acute graft-versus-host disease.