DUBLIN – Shares in Bone Therapeutics SA dropped by as much as 38% Aug. 30 after the regenerative medicine firm reported that its lead program, JTA-004, flopped in a phase III trial in osteoarthritis of the knee. The candidate therapy, designed to lubricate and protect damaged cartilage in affected joints, failed to meet the primary endpoint of being superior to placebo in reducing pain, as measured on the Western Ontario McMaster Universities Osteoarthritis Index (Womac) pain subscale three months after treatment. Read More
Laronde Inc., a company developing a new class of closed-loop RNA constructs for future medicines, has raised $440 million in series B financing. Unfurling at a pivotal moment for RNA-based therapies and vaccines, the company's approach is a bet on early evidence that its "endless" RNA loops can produce stable, enduring and tunable protein expression to fight disease. Read More
Sure H.R. 3 could save the U.S. government hundreds of billions of dollars on drug spending, but that savings comes at a long-term cost in innovation that’s higher than the Congressional Budget Office (CBO) initially forecast. Read More
New data from Nrx Pharmaceuticals Inc.’s phase IIb/III trial for treating acute respiratory failure due to critical COVID-19 showed that Zyesami (aviptadil) improved the lung’s ability to transmit oxygen within a day of administration. The respiratory distress ratio’s average difference between those participants receiving aviptadil and placebo was clinically meaningful and statistically significant. The benefit was found across participants, all baseline severities and hospitals of all types. Read More
The CDC’s Advisory Committee on Immunization Practices (ACIP) heard a safety update on COVID-19 vaccines, took up the matter of booster shots, and voted on whether to recommend the vaccine from Pfizer Inc. and Biontech SE for people 16 and older, now that it’s fully licensed. Under an emergency use authorization, the vaccine can be given to people 12-15 years old. Read More
Binhui Biopharmaceutical Co. Ltd.’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from the FDA. The development marks the first oncolytic viral candidate developed by a Chinese company to win a go-ahead for trials abroad, it said. Read More
New hires and promotions in the biopharma industry, including: Boundless, Convergent, Enochian, Galectin, H3, Rubius, Therapeutic Solutions, Xbiotech, Ziopharm. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Aileron, Airway, Alzecure, Amgen, Ose, Quantum. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Immunobrain, Insilico, Noxopharm, Satellos, Sorrento, Tilt, Tumorgen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Biomarin, Enzene, Incyte, Junshi, Laekna, Morphosys, Pendopharm, Roche. Read More