The FDA has authorized two batches of Johnson & Johnson’s COVID-19 vaccine from a troubled Emergent Biosolutions Inc. manufacturing facility to be made available under emergency use authorization (EUA) while determining that several other batches were unsuitable for use. While the FDA would not confirm the number of unsuitable batches, the newly authorized batches, however, can be used in the U.S. or exported. Read More
New phase III data on Novan Inc.'s molluscum contagiosum candidate showed it cleared all lesions associated with the highly contagious viral skin infection in 32.4% of trial participants who received it vs. 19.7% provided a placebo. Paired with what company President and CEO Paula Brown Stafford called "strong safety," the result gives the company's team confidence as it moves toward an NDA submission for the topical antiviral, SB-206, she said. Read More
It’s back to the drawing broad for Vertex Pharmaceuticals Inc. and its efforts to develop treatments for the rare disease alpha-1-antritrypsin deficiency (AATD), after its VX-864 produced disappointing results in a phase II trial. Read More
Genhouse Bio Co. Ltd. closed a series A financing round to raise more than ¥200 million (US$31 million) to support phase I studies of KRAS inhibitor GH-35 and SHP2 inhibitor GH-21 in China. The startup expects to enroll patients in trials testing the two compounds in the second half of this year, CEO Wang Kuifeng told BioWorld in an exclusive interview. Read More
Beigene Ltd. unveiled positive interim results from its Alpine phase III trial comparing its small-molecule BTK inhibitor, Brukinsa (zanubrutinib), to Abbvie Inc.’s Imbruvica (ibrutinib), lending validity to one of the company’s most important development programs. Read More
Sanofi SA has announced new pivotal data that will form the basis of a refiling of rare disease drug sutimlimab for people with cold agglutinin disease (CAD). Read More
Researchers at the University of Washington reported in the May 31, 2021, issue of Nature Medicine that artificial intelligence (AI) algorithms meant to recognize COVID-19 infections based on chest X-rays picked up on confounders, selecting “shortcuts” such as patient age or positioning in the X-ray as a basis for their predictions. Read More
Data from a prospective study rolled out by Allakos Inc. last month at the Digestive Disease Week meeting made the case for broader prevalence than previously believed of eosinophilic gastritis and/or eosinophilic duodenitis – and the Redwood City, Calif.-based firm may have just the drug for the conditions in lirentelimab (AK-002). Read More
Takeda Pharmaceutical Co. Ltd. said findings from its phase III Solstice study testing oral antiviral TAK-620 (maribavir) in treating solid organ transplant recipients with cytomegalovirus infections resistant or refractory to prior therapy (R/R CMV), showed twice the rate of confirmed CMV viremia clearance compared to other conventional therapies. Read More
TORONTO – Nanology Labs Inc. has raised C$3 million (US$2.49 million) in seed funding to advance development of a polymer-lipid platform that transports nanoparticles into human cells where they “reprogram” hypoxic or oxygen-deprived cancer tumors. Read More
New and updated preclinical and clinical data presented by biopharma firms at the European Hematology Association 2021 Virtual Congress, including: Abbvie, Acceleron, Agios, Alexion, Aptose, Autolus, Beigene, Bergenbio, Bluebird, BMS, Caelum, Celyad, Constellation, Curis, Editas, Equillium, Forma, Genentech, Global Blood, Imago, Imara, Immunicum, Keros, Menarini, Mustang, Novartis, Oryzon, Protagonist, Ryvu. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, Adamis, Aligos, Allysta, Anji, Biogen, BMS, Cue, Hibercell, Immunitybio, Inotrem, Inventiva, Lysogene, Mediwound. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astra, Biovie, Campbell, Innocan, Lysogene, Mayo, Moderna, Modus, Neurmedix, Recode, Satt Conectus, Splisense, Tel Aviv University, Sorrento, Tabuk, Therapeutic Solutions. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Direct, Genetx, Moderna, Purdue, Soligenix, Ultragenyx. Read More
