BioSpace News Archive

The companies’ antibody-drug conjugate improved progression-free survival with a “trend in improvement” for overall survival in patients with HR-positive, HER2-low or negative breast cancer.

The companies, which are collaborating on a drug combination to treat locally advanced and metastatic urothelial cancer, announced Friday that their Phase III trial met dual primary endpoints.

Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.

ARS Pharmaceuticals, Intarcia Therapeutics and Taysha Gene Therapies this week got stark reminders of the difficulties in getting treatments through the regulator’s approval process.

Recent drug approvals have shone a light on the role that patient advocacy groups can play in the regulatory process—but some experts have questions about the ethics of this influence.

A U.S. federal court upheld a prior ruling in favor of Roche’s Genentech, finding that its blockbuster hemophilia treatment Hemlibra did not infringe on patent protections held by Takeda’s Baxalta.

Merck, known as MSD outside of the United States and Canada, announced positive topline results from the Phase 3 KEYNOTE-A39 trial, which was conducted in collaboration with Seagen and Astellas, evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev versus chemotherapy in patients with previously untreated locally advanced or metastatic urothelial carcinoma.

Faron Pharmaceuticals Ltd. announces that the extraordinary general meeting of the Company took place , September 22, 2023 in Turku, Finland.

Bristol Myers Squibb Announces Perioperative Regimen of Neoadjuvant Opdivo (nivolumab) and Chemotherapy Followed by Adjuvant Opdivo Significantly Improves Event-Free Survival in Patients with Resectable Non-Small Cell Lung Cancer.

Neoleukin Therapeutics, Inc., today announced that its Board of Directors (“Board”) has approved a reverse stock split of the Company’s outstanding shares of common stock at a ratio of 1-for-5.