Boehringer Ingelheim GmbH’s zongertinib enters the market as the first oral HER2-targeted therapy for patients with non-small-cell lung cancer, following an accelerated approval by the U.S. FDA. Branded Hernexeos, the drug is cleared for use in adults with unresectable disease or whose tumors have HER2 tyrosine kinase domain activating mutations and who have received prior systemic therapy. Read More
Billing it as a necessary reform to protect tax dollars from frivolous government spending, redundancy and waste, U.S. President Donald Trump issued a new executive order (EO) requiring his political appointees to sign off on grants and awards from agencies such as the NIH and to monitor those awards over time to ensure they’re being used properly. Read More
IO Biotech ApS will discuss this fall with the U.S. FDA the data package related to Cylembio (imsapepimut and etimupepimut, adjuvanted) after the off-the-shelf therapeutic cancer vaccine prospect missed “by a hair” the primary endpoint in a pivotal phase III melanoma trial, said CEO Mai-Britt Zocca. Read More
After about a two-week absence as the U.S. FDA’s CBER director, Vinay Prasad’s return overall prompted a mild reaction on Wall Street for some stocks tied to companies developing cell and gene therapies. Read More
The largest genome-wide association study to date of myalgic encephalomyelitis/chronic fatigue syndrome has identified eight genetic loci that are significantly associated with the chronic debilitating condition. Read More
Syntara Ltd.’s stock plummeted 52% on news that the FDA recommended an additional phase IIb trial following a type C meeting about the company’s clinical development plan for lysyl oxidase inhibitor amsulostat (SNT-5505, formerly PXS-5505) in myelofibrosis. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Annexon, Bicycle, Biontech, Curevac, GSK, Neuren, Pfizer. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avobis, Capricor, Everest, Junshi, Kedrion. Read More
