Parent and patient testimony about the life-altering changes they experienced with Biomarin Pharmaceutical Inc.'s Kyndrisa wasn't enough to wholeheartedly convince an FDA advisory committee of the efficacy of the exon 51-skipping drug for Duchenne muscular dystrophy (DMD). Read More
The FDA cleared Eli Lilly and Co.'s Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small-cell lung cancer (NSCLC) who have not previously received medication for their later-stage disease. Read More
SHANGHAI – Zai Labs Ltd., of Shanghai, signed a China rights deal, including Hong Kong and Macau, for a coveted late-stage targeted non-small-cell lung cancer (NSCLC) therapy, HM61713, from Hanmi Pharmaceuticals Co. Ltd., of Seoul, South Korea. Read More
Researchers at Isis Pharmaceuticals Inc. and the University of California at San Diego have reported on a STAT3-targeting antisense oligonucleotide (ASO) that "produced robust antisense-mediated inhibition of target RNA molecules in tumors of several preclinical models, and demonstrated single-agent antitumor activity in several highly refractory cancer patients in a phase I dose-escalation study," corresponding author Robert MacLeod told BioWorld Today. Read More
"The glaucoma space is heating up and drug delivery is at the center of that," Benjamin Yerxa, president and co-founder of Envisia Therapeutics Inc., told BioWorld Today. Read More
NEW DELHI – India's Central Drugs Standards Control Organisation (CDSCO) issued a slew of notifications in November aiming to speed up clinical trial approvals following concerns from companies that many regulatory requirements are duplicated and often tedious. Read More
SHANGHAI – Newly formed Just Biotherapeutics Inc., a vertically integrated biotech start-up with a focus on oncology and anti-infectives, has come to life in two places at once, setting up in both Seattle and Hangzhou. In doing so, it is putting an entirely new spin on the usual way of doing business between East and West. Read More
Brickell Biotech Inc., of Miami, secured the exclusive worldwide rights to a series of retinoic acid-related orphan nuclear receptor gamma (RORy) inhibitors from Orca Pharmaceuticals Inc., of Oxford, U.K., and New York University. Under the terms of the agreement, Brickell will assume the responsibility for the continued research and development of those RORy inhibitors, initially targeting the topical treatment of psoriasis. Read More
Novogen Ltd., of Sydney, said it engaged contract research organization Novotech for an upcoming phase I study of Cantrixil, a cyclodextrin-based drug containing the active ingredient TRXE-002-1, in patients with refractory/recurrent peritoneal malignancies with malignant ascites, including ovarian cancer. Read More
