The use of organoids in preclinical research has reached a tipping point, with U.S. FDA approval of the first drug to enter clinical trials on the basis of efficacy data derived only from these advanced cell models. Read More
China’s NMPA gave the green light to Simcere Pharmaceutical Group Ltd. for Cosela (injectable trilaciclib hydrochloride) as a treatment to decrease the risk of chemotherapy-induced myelosuppression. It is intended for adult patients with extensive-stage small-cell lung cancer (ES-SCLC), before they undergo a platinum/etoposide-containing regimen. Read More
It’s a delicate time in Europe, where the recovery from the pandemic has been stifled by the war on its doorstep in Ukraine. Although the crisis caused by the Russian invasion is dominating the short-term political agenda, there are serious concerns about Europe’s long-term economic prospects and whether its research-led industries are falling by the wayside. Read More
Controlling the epigenetics of a patient, figuring out what genes are expressed and understanding their level of expression, is at the center of Epic Bio, a new company founded by Stanley Qi, co-inventor on the CRISPR patent held by the University of California. Read More
The U.S. FDA’s latest draft guidance for premarket cybersecurity considerations expands considerably on the previous edition, and suggests that the manufacturer’s cybersecurity responsibilities include security in a health care facility’s network. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cocrystal, Contrafect, LG, Novan, Regeneron, Revelation, Roche, Sanofi, Starton, Theratechnologies, Xequel. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biora, Creative, Cytomx, Genscript, Grunenthal, Halberd, Pasithea, Repertoire, SK, Ultragenyx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Beigene, G1, Lantern, Novavax, Revolo, Sinovac, Summit. Read More
