Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval. Read More
When it comes to recommending reforms for the U.S.’ 30-year-old 340B Drug Discount Program, there’s one thing drug manufacturers and hospitals agree on – pharmacy benefit managers (PBM) and other middlemen should not be profiting from a program that’s intended to help uninsured and vulnerable patients gain access to affordable prescription drugs or other health care services. Read More
On Aug. 3, Sunho Biologics Inc. filed to list on the Hong Kong Exchange, armed with its antibody and immunocytokine drug pipeline and post-investment valuation of ¥1.41 billion (US$196 million). Read More
When looking for a name, the founders of startup Nexo Therapeutics Inc., which recently emerged from stealth mode with a $60 million series A financing and a research collaboration with the University of Texas MD Anderson Cancer Center, sought a moniker that truly captured its approach to drug development. Read More
New company Amber Bio emerged on Aug. 3 with $26 million in seed funding that will help advance an RNA-based gene editing platform that leverages Cas-based systems to create safer medicines. Through the company’s platform, a single drug can be used to treat diseases with high allelic diversity. The company plans to develop its own genetic medicines internally, while also licensing out the technology to expand its reach. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aravive, Arbele, Areteia, Asklepios, Bolt, Cage, Celsius, CNS, Perfuse, Regeneron, Ultimovacs, Vertex, Xylocor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Assertio, Catalent, Evox, Fuji, Galapagos, Ionis, Kiora, Mind, Mithra, Novartis, Zydus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 180, Aardvark, ABM, Orchard, Taiho. Read More
