As largely expected, the FDA on Oct. 20 authorized the use of booster doses for COVID-19 vaccines from Moderna Inc. and Johnson & Johnson, in line with last week’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings. It also cleared the way for “mix-and-match” boosters, allowing eligible people to receive boosters from any of the FDA-approved vaccines, regardless of which vaccine they received originally. Read More
With only three bispecific antibodies on the market, potential for the technology remains largely untapped. Johnson & Johnson’s Janssen Biotech Inc. is trying to change that. In a new deal with U.K.-based F-star Therapeutics Inc., it’s seeking develop a new generation of bispecifics for undisclosed targets. Read More
Stealth Biotherapeutics Corp.’s refusal to file (RTF) letter from the FDA regarding the NDA for elamipretide, a candidate that targets mitochondria in the treatment of Barth syndrome, hardly knocked the stock, as investors likely saw the bad news coming. Read More
The Menarini Group and Radius Health Inc.’s phase III Emerald study of oral elacestrant as a monotherapy vs. standard of care in treating estrogen receptor-positive/HER2-negative advanced or metastatic breast cancer hit its two primary endpoints. The study’s top-line data, according to the companies, showed statistically significant progression-free survival in both the overall population and in patients with tumors harboring estrogen receptor 1 mutations. Read More
Cerecin Inc. has raised $40 million in an oversubscribed round of financing, paving the way for a potential listing in South Korea. Proceeds of the financing will fund the expansion of the company’s current studies and support the planning and initiation of a global phase III study of its lead candidate, tricaprilin, in Alzheimer’s disease. Read More
Biotech stocks and the overall market have taken divergent paths in the past month, not unlike what was seen throughout 2020, except this time, they are moving in opposite directions. While BioWorld’s Drug Developers Index (BDDI) appeared to be on the upswing only a month ago, it changed course in the final weeks of September. Read More
Shenzhen Chipscreen Biosciences Co. Ltd.’s Bilessglu (chiglitazar), a peroxisome proliferator-activated receptor (PPAR) pan-agonist globally for the treatment of type 2 diabetes mellitus, has received marketing approval from the NMPA in China. Read More
New hires and promotions in the biopharma industry, including: Alopexx, Aptinyx, Avalyn, Curexsys, Elevation, Humanigen, Jcyte, Novome, Opus, Reflexion, Vtv. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abivax, Atea, Avadel, Avrobio, Cour, Dicerna, Edesa, Eli Lilly, Entasis, Galera, Harbour, Immune, Immunitybio, Inhibikase, Iterion, Noxxon, Ono, Opthea, Paratek, Pharnext, Seal Rock, Sifi, Small, Statera, Ultragenyx, Vyne. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Aim, Alphageneron, Ambulero, Biogen, Biontech, Chipscreen, First Wave, Genmab, Janssen, Innocare, Moleculin, Pfizer, Plus, Sage. Read More
