BioSpace News Archive

The FDA approved AstraZeneca’s Imfinzi plus with gemcitabine-cisplatin chemotherapy as the first immunotherapy for adult patients with locally advanced or metastatic biliary tract cancer.

The FDA removed the clinical hold on Sarepta’s investigational treatment for certain types of DMD after the company agreed to adjust its clinical trial protocols.

Athira Pharma announced Tuesday it will study the stand-alone effects of its Alzheimer’s candidate fosgonimeton (ATH-1017). The drug failed to meet the endpoint in a Phase II study earlier this year.

Gilead, Merck, Daiichi Sankyo, HUTCHMED and BMS previewed data to be presented at the European Society for Medical Oncology Congress 2022, taking place Sept. 9-13.

InnoCare Pharma announced that BTK inhibitor orelabrutinib has been granted priority review for the treatment of relapsed or refractory Marginal Zone Lymphoma by the Center for Drug Evaluation of the China National Medical Products Administration, which accepted the supplemental New Drug Application of orelabrutinib for the treatment of R/R MZL recently.

Pixium Vision SA, a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, announces that senior management will participate in the following investor conferences during September 2022:

Valneva SE, a specialty vaccine company, announces that The Lancet Infectious Diseases, a peer-reviewed medical journal, has published the Company’s pivotal Phase 3 clinical data for its inactivated, whole-virus COVID-19 vaccine, VLA2001.

Galderma has announced it will be showcasing its latest scientific updates at the 31st European Academy of Dermatology and Venereology congress in Milan, September 7-10, 2022.

Spexis AG announced its financial results for the first half of 2022 and provided a strategic business update.

IRLAB Therapeutics AB, a clinical-stage biopharmaceutical company discovering and developing novel treatments for the most troublesome symptoms of Parkinson’s disease, announced that its partner Ipsen has initiated clinical studies with drug candidate mesdopetam in accordance with its development plan.