Boehringer Ingelheim announced the company’s intention to pump €25 billion ($27 billion) into its R&D pipeline over the next five years.
Interim data from Roche Group member Genentech’s first randomized study of a candidate treatment for extensive-stage small cell lung cancer (ES-SCLC) failed to meet the clinical trial’s co-primary endpoint against the hard-to-treat disease.
Pfizer announced March 24 that the company received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the vaccine candidate PF-06928316 (RSVpreF), intended to prevent infections caused by a respiratory syncytial virus (RSV).
Provention Bio is resubmitting a Biologics License Application (BLA) for teplizumab, a drug intended to delay the onset of Type 1 diabetes (T1D) in at-risk individuals, following a Type B pre-BLA resubmission meeting with the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration awarded Roche’s Alzheimer’s disease drug candidate Breakthrough Therapy Designation, bringing the IgG1 antibody gantenerumab closer to finally receiving full FDA approval.
AstraZeneca’s candidate breast cancer therapy Enhertu received a fourth Breakthrough Therapy Designation from the U.S. Food and Drug Administration after the health regulator issued another BTD based on a Phase III trial presented at the European Society for Medical Oncology Congress 2021.
Massachusetts-based biotechnology firm Biogen and its Tokyo-based partner Eisai are seeking a speedy approval from the U.S. Food and Drug Administration for a second Alzheimer’s disease drug, lecanemab.
The U.S. Food and Drug Administration greenlit the classification of California-based biotechnology firm Genentech’s Venclexta (venetoclax) and azicitidine combination as a Breakthrough Therapy Drug.
Data from a mid-stage clinical study of an experimental vaccine candidate developed by Affinivax and Astellas Pharma for Streptococcus pneumoniae shows ASP3772 is well tolerated and generated an antibody response against the deadly bacterial infection.
The U.S. Food and Drug Administration made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.