BioSpace News Archive

Following a months-long safety review, the regulator on Thursday said it is now requiring updated black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.

Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.

French healthcare and pharma company Sanofi will terminate an undisclosed number of positions in its U.S. vaccines commercial unit in an effort to streamline the strategic sales structure.

If a company’s final sales end up falling short of the consensus analyst estimate, then they have missed their number. Johnson & Johnson was close in the first quarter of 2024 but ultimately no cigar.

Ahead of launching its Humira biosimilar Simlandi, Alvotech and Teva on Friday announced they have signed a long-term agreement with an undisclosed strategic partner to help boost patient access to the drug.

Ensysce Biosciences, Inc. today announced the Company’s webcast presentation and discussion during the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on April 17, 2024 is available on Ensysce’s Investor Relations website at ir.ensysce.com and can also be viewed here.

Outset Medical, Inc. today announced that it will release financial results for the first quarter of 2024 after the close of trading on Wednesday, May 8, 2024.

ACTG today announced the opening of A5374, a phase 1/2a study evaluating the safety, tolerability, and antiviral effect of a novel combination regimen that includes therapeutic T-cell vaccines, two broadly neutralizing antibodies (bNAbs), and an immune-system boosting treatment among people living with HIV who started antiretroviral treatment (ART) during acute (early) HIV infection.

Cochlear Limited (ASX: COH) obtained U.S. Food and Drug Administration (FDA) clearance to lower the age of the Cochlear™ Osia System from 12 years-old to 5-years-old for children with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness (SSD).

For the roughly 1.5 million Americans per year who survive a traumatic brain injury, health outcomes vary widely. Not only can these injuries lead to a loss of coordination, depression, impulsivity, and difficulty concentrating, but they come with an amplified risk for developing dementia in the future.