New positive phase III study results for Regeneron Pharmaceuticals Inc.’s COVID-19 monoclonal antibody cocktail show a single dose reduced the risk of contracting the virus by 81.6% during a two- to eight-month follow-up period. The strong data go along with Pfizer Inc.’s recent positive results for its oral antiviral, Paxlovid, hinting that COVID-19 therapeutics could begin cutting into powerful mRNA vaccine margins from Pfizer Inc.-Biontech SE and Moderna Inc. Read More
Results from two pivotal phase III trials testing Glaxosmithkline plc's daprodustat against anemia due to chronic kidney disease (CKD) found the oral hypoxia-inducible factor prolyl hydroxylase inhibitor helped both non-dialysis and dialysis patients improve or maintain hemoglobin levels without increased cardiovascular risk vs. standard-of-care erythropoietin stimulating agents. Though already approved in Japan as Duvroq, what future the drug might face in the U.S., where the same-class drug roxadustat garnered an FDA complete response letter, remained an open question. Read More
After a shaky start to the year, Autolus Therapeutics plc has revived its fortunes, with Blackstone Life Sciences investing up to $250 million to fund its CAR T-cell technology and lead product targeting acute lymphoblastic leukemia. Read More
Marengo Therapeutics Inc. is opening up a new front in the war on cancer by selectively deploying a tumor-infiltrating subpopulation of T cells, which can be activated by a newly identified, antibody-based mechanism. The Cambridge, Mass.-based company is taking forward a scientific concept that has been germinating for several years at founding investor and company creator ATP, which has now launched the firm with an $80 million series A round. Marengo is gearing up for a first clinical trial in 2022. “It’s a new chapter in T-cell biology,” CEO Zhen Su told BioWorld. Read More
Data from Chinook Therapeutics Inc. from an ongoing phase I/II trial with BION-1301 in IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week, and from Vera Therapeutics Inc. with atacicept, set Wall Street abuzz about chances for the two compounds relative to each other. Read More
Aptose Biosciences Inc. has bought over the worldwide rights to Hanmi Pharmaceutical Co. Ltd.’s myeloid kinome inhibitor in a deal worth up to $420 million. Seoul, South Korea-based Hanmi has granted Aptose exclusive worldwide rights to HM-43239 for all indications. The candidate was developed for relapsed or refractory acute myeloid leukemia. Read More
A surge in deal activity over the last few months has placed 2021 in the running for beating 2020, the best year on record, and becoming the top year for the biopharma industry to date.
BioWorld has recorded 1,680 deals valued at $167.39 billion in 2021 vs. 1,744 deals valued at $159.98 billion by this point last year. That puts 2021 ahead by about 5% on deal values. Read More
A U.S. district court jury in Boston found Nov. 5 that Gregory Lemelson and Massachusetts-based Lemelson Capital Management LLC made fraudulent misrepresentations about Ligand Pharmaceuticals Inc. to drive down the San Diego company’s stock price. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biocryst, Calithera, Chinook, Cyclacel, Deciphera, Dicerna, Karyopharm, Medicure, Morphosys, Novartis, Novo, Omeros, Pfizer, Vascular Therapies. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bharat, Novavax, Nrx, Ocugen, Opiant, Tris. Read More
