The U.S. FDA is on a roll with new drug approvals for Pfizer Inc., clearing severe alopecia areata treatment Litfulo (ritlecitinib) just under a month after giving the go-ahead for the firm’s oral COVID-19 antiviral, Paxlovid (nirmatelvir/ritonavir). Read More
While investors focused on the top-line miss from Avalo Therapeutics Inc.’s phase II study of AVTX-002 (quisovalimab) in non-eosinophilic asthma, sending company shares (NASDAQ:AVTX) falling 89% to close at 50 cents June 26, the company pointed to promising trends seen in an exploratory analysis affirming the potential of targeting LIGHT. Read More
As earlier-stage efforts in oncology continue with BMF-219, Biomea Fusion Inc. rolled out new clinical data June 23 from the first two cohorts of patients with type 2 diabetes enrolled in the phase II part of its ongoing phase I/II study called Covalent-111 testing the same compound, an oral covalent menin inhibitor. Read More
A tough spring has settled into a cruel summer for Fibrogen Inc. as the company has stumbled for the third time in two months. The newest problem is top-line results showing the phase III Zephyrus-1 study of pamrevlumab, a monoclonal antibody, missed its primary endpoint for treating idiopathic pulmonary fibrosis. Read More
The U.S. FTC picked up six allies in its unprecedented effort to stop Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc, as the attorneys general for California, Illinois, Minnesota, New York, Washington and Wisconsin joined the agency in signing onto an amended complaint filed under seal June 22 in the U.S. District Court for the Northern District of Illinois. Read More
Shionogi & Co. Ltd.’s U.S. subsidiary Shinogi Inc. will acquire San Diego-based Qpex Biopharma Inc. in a deal worth up to $140 million that expands Shionogi’s pipeline of infectious disease agents and also adds to Brii Biosciences Ltd.’s pipeline. Read More
Edding Group Co. Ltd. announced June 23 it filed for an IPO on the Hong Kong Exchange – news that comes amid a steep drop in China’s biopharma IPO market forecasting sluggish activity in a near-frozen “capital winter.” Read More
Clinical data in the first five months of 2023 is remarkably consistent to last year. BioWorld reported on 1,449 drugs in phase I-III this year, compared to 1,452 in the same time period in 2022. Numbers are down 12.13% from 1,649 in 2021, but up from 2020’s 1,419 and 2019’s 1,173. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Aslan, Gilead, Hifibio, Intercept, Sagimet, Sumitomo. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adamis, Advancell, Astellas, DMK, Erytech, Inveric, Pahxiam, Pherecydes, Point, TFF, Tonix, Ubsher-Smith. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amylyx, Astrazeneca, Boehringer Ingelheim, Erasca, Gilead, Intercept, Janssen, Leo, Lianbio, Moderna, Molecure, Pfizer, Sarepta, Zealand. Read More
