As new and ongoing drug shortages in the U.S. limit patients’ access to essential medicines and life-saving cancer treatments, the blame largely has fallen on increased demand, quality problems, the supply chain and lack of transparency in that chain. Read More
The death of a patient caused Seattle Children's to pause its phase I study of relapsed/refractory pediatric acute myeloid leukemia (AML). It’s another hitch in the world of ground-breaking CAR T treatments that can have a serious downside. Read More
Patients with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes had a 44% reduction in liver fat after receiving Inventiva Pharma SA’s PPAR agonist, lanifibranor, in a phase II trial, findings that caused the Daix, France-based company’s stock to soar. Read More
The June 14 hearing of the House Appropriations Committee was focused largely on spending levels for the Department of Agriculture, but there was also some concern over the proposed spending levels for the FDA. One of the more conspicuous features of the legislative report is the recommendation that the FDA finalize guidance or rulemaking for risk-based regulation of lab-developed tests (LDTs), a clear departure from the stance taken by Congress for a number of years. Read More
Itabmed Ltd. received an IND approval to start a phase I trial of its CD3-activating bispecific antibody A-337 for the treatment of patients with advanced solid tumors. Read More
Biopharmas raising money in public or private financings, including: APT, Aytu, Cancervax, Coeptis, Disc, First Wave, Immix, Kura, Oculus and RDT. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aclaris, Alladapt, Autifony, Bioinvent, Biostar, Candel, Chinook, First Wave, Geron, Journey Medical, Lexeo, Medexus, Olix, Sapience, Seagen, Valneva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: AIP, Amgen, Biogen, Blue Water, Evolveimmune, Globestar, Horizon, Lava, Merck & Co., Neurosense, Pfizer, Raser, Seagen, Trestle and Xspire. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Can-Fite, Ferring, Highfield, Ironwood, Starton, Stealth. Read More
