A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment. Read More
In a return to the pre-pandemic days, biopharma deals with nonprofit or government entities and industry grants appear to be tracking closer to 2019 figures, as the flurry of activity over the last two years dissipates. Through mid-April in 2022, BioWorld has tracked 246 bio/nonprofit deals worth $1.02 billion, and a total of 86 grants valued at $328.13 million. Read More
As Wall Street awaits data from VBL Therapeutics Inc.’s phase III trial with ofranergene obadenovec (ofra-vec, also known as VB-111) in platinum-resistant ovarian cancer (PROC), the company hosted a key opinion leader conference call on the gene therapy’s likely market reception along with assorted details regarding the upcoming results from the 409-patient experiment known as Oval. Read More
The potential €100 million (US$114 million) deal disclosed Feb. 10 between infectious disease specialist Aicuris Anti-infective Cures AG and Hybridize Therapeutics for a BK virus therapy stimulated interest in the space, where a number of players are seeking a treatment. None exists today. Read More
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: Akeso, Ascentage, Celsion, Foghorn, Onconano.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agios, Biontech Calcimedica, Evelo, Exelixis, Genmab, Inmune, ISA, Lexaria, Marinus, Pfizer, Sanofi, Sciwind, Surface, Taurx, Vendanta.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Ankyra, Bharat, Biohaven, ICER, Ocugen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Astellas, Coherus, Innovent, Inxmed, Merck, PTC, Regeneron. Read More
