CRISPR-based cell therapies continued to gain steam Sept. 27 with the announcements of a potentially valuable big pharma collaboration and an ambitious global regulatory push. Read More
While it continues to deny all kickback allegations raised in a whistleblower suit filed seven years ago, Biogen Inc. agreed Sept. 26 to pay $900 million to resolve claims that it paid doctors in the U.S. to prescribe its multiple sclerosis drugs from 2009 through March 2014. Read More
A serious adverse event (SAE) in one participant has led the U.S. FDA to place a partial clinical hold on Avidity Biosciences Inc.’s lead program. The action is centered on the phase I/II Marina study of AOC-1001, an antibody oligonucleotide conjugate for treating myotonic dystrophy type 1, the most common form of muscular dystrophy in adults. Read More
The U.S. FDA approved Santen Pharmaceutical Co. Ltd.’s and UBE Industries Ltd.’s Omlonti (omidenepag isopropyl) ophthalmic solution for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. It is the second FDA-approved product from Japan-based Santen in the last 15 months for patients in the U.S. with vision conditions. Read More
Jilin Huisheng Biopharmaceutical Co. Ltd., a non-wholly owned subsidiary of Sihuan Pharmaceutical Holdings Group Ltd., has raised ¥500 million (US$70 million) in a series A round. Huisheng, which has developed a pipeline of programs addressing both diabetes and its complications, plans to use the new funds to speed up its clinical trials and purchase manufacturing equipment, according to Che Fengsheng, executive director and chairman of Sihuan Pharma. Read More
The amount of clinical news in 2022 continues to lag last year, partly due to a decline in COVID-19-related data. Through the last week of September, there have been a total of 2,495 phase I, II and III clinical entries, compared with 3,027 during the first three quarters of 2021. This represents a drop in activity of 17.6%. Read More
As part of its obligations under the 21st Century Cures Act, the U.S. FDA is proposing two new rules to harmonize sections of its regulations on human subject protection and institutional review boards with the revised Common Rule, which provides for the protection of human subjects in federally funded research. Read More
An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anebulo, Arcutis, Atamyo, Bioheng, Brii, Dystrogen, Jasper, Moonlake, Pulmatrix, Sorrento, Tolerogenixx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AC Immune, Amerisourcebergen, Celsion, Cytrx, Lipocine, Navigo, Novavax, Outlook, Sciwind, Seagen, Synerk, Zai. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aqualung, Atea, Catalym, Everest, Pfizer, Y-mabs. Read More
