For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26. Read More
Apellis Pharmaceuticals Inc.’s CEO, Cedric Francois, said his firm’s phase III study called Pegasus testing pegcetacoplan, or APL-2, in paroxysmal nocturnal hemoglobinuria (PNH) “finally established that there is an important unmet medical need in this disease.” Read More
Despite a rough ride on the capital markets for much of the year, particularly in the second and third quarters, this did not prevent the biopharmaceutical sector from attracting a significant amount of capital. According to BioWorld, when the curtain closed on 2019, approximately $57.6 billion had been generated by global public and private companies. Read More
An aspect of artificial intelligence (AI) that’s often misunderstood is its power, something Deep Genomics Inc.’s founder and CEO, Brendan Frey, does his best to clarify for collaborators and his employees. “One problem of AI is thinking of it as a magic black box that can solve any issue,” Frey told BioWorld soon after the company announced a $40 million series B financing. “If you take that approach, it won’t help.” Read More
BEIJING – Yisheng Biopharma Co. Ltd., of Beijing, said it has inked a pact with U.S. biotech Tavotek Biotherapeutics, of Ambler, Pa., to co-develop a combination therapy with Yisheng’s YS-ON-001/002 and Tavotek’s Tavo-301/303, which the companies hope could prove a more efficacious cancer treatment than the popular anti-PD-1/PD-L1 monotherapies. Read More
Novome Biotechnologies Inc., a startup developing a hyperoxaluria therapy based on controlled colonization of the gut with engineered bacteria, has landed a $33 million series A financing and appointed former Achaogen Inc. chief Blake Wise as CEO. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More
