Posts

Spectrum Pharmaceuticals Inc. said on Friday the U.S. Food and Drug Administration (FDA) declined to approve its experimental lung cancer drug due to inadequate data, prompting the drugmaker to cut jobs.

The U.S. Food and Drug Administration’s (FDA) staff on Tuesday raised concerns over the safety of Spectrum Pharmaceutical’s experimental cancer drug and questioned the benefits it provided over existing therapies, dragging its shares 30%.

Gilead Sciences Inc.’s Trodelvy extended by 3.2 months the survival of patients with advanced stages of a common type of breast cancer, according to data released ahead of a presentation at a European cancer meeting on Friday.

Weeks after AstraZeneca and Daiichi Sankyo were able to move the bar in the treatment of metastatic breast cancer with Enhertu, Gilead Sciences is answering that challenge with Trodelvy.

AstraZeneca said a late-stage trial had confirmed the benefit of breast cancer drug Enhertu in patients with an advanced form of the disease who had been previously treated with another therapy.

As the biotech world awaits the announcement of Merck’s anticipated buyout of Seagen, an arbitrator came down on the side of Daiichi Sankyo in a patent battle against the Seattle-based biotech.

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu has been approved by the U.S. Food and Drug Administration as the first HER2-directed medicine for patients with HER2-mutant metastatic NSCLC, a particularly lethal form of the disease.

The drug received priority review and breakthrough therapy designations for the indication, and approval was granted to Daiichi Sankyo four months ahead of the Prescription Drug User Fee Act deadline.

The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, today announced the 2022 Prix Galien USA Award nominees for “Best Biotechnology Product,” “Best Pharmaceutical Agent,” and “Best Medical Technology.” Winners will be announced during the Prix Galien USA Awards Ceremony on October 27, 2022, at the American Museum of Natural History in New York City.

On Monday, the high-profile partnership between Japan’s Daiichi-Sankyo and British-Swedish multinational AstraZeneca announced that the United States Food and Drug Administration has accepted their supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), their HER2-directed candidate for unresectable or metastatic breast cancer.