Detailed data are expected later, but partners Biontech SE and Duality Biologics Co. Ltd. are celebrating a phase III interim analysis readout demonstrating that HER2-targeting antibody-drug conjugate (ADC) trastuzumab pamirtecan hit the primary endpoint of progression-free survival in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and a taxane-based chemotherapy. Read More
Braveheart Bio Inc. is paying $65 million up front to license Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s oral hypertrophic cardiomyopathy drug candidate called HRS-1893. Read More
The BioWorld Neurological Diseases Index showed signs of recovery in August, narrowing its year-to-date decline to 14.31%, compared to a steeper drop of 22.34% at the end of May. Momentum shifted notably over the summer, with 17 of the 20 component companies posting gains between June and August. This marks a reversal from May, when 15 of the 20 stocks were in the red. Read More
After July’s first-ever release of more than 200 complete response letters (CRLs) by the U.S. FDA, the agency now says it will release letters shortly after sponsors receive them. In addition, the FDA released a new batch of 89 CRLs from 2024 to now that are tied to pending or withdrawn applications. Read More
A recent paper in the Journal of Clinical Medicine quantified some of the potential bodily ravages ahead for patients with hypoparathyroidism (hypoPT), specifically the loss of kidney function, with the risk of chronic kidney disease going up every year by 11%. A handful of drug developers continue to advance prospects in hypoPT, where Ascendis Pharma A/S’ hormone replacement therapy Yorvipath (palopegteriparatide) – the first and only treatment for adults with the rare endocrine disease – has set the bar for efficacy. Read More
Biopharma financing activity has continued to remain low compared to the highs seen in recent years, with a total of $39.83 billion raised across IPOs, follow-on offerings, public/other and private financings in the first eight months of 2025. Read More
Biopharma happenings, including deals and partnerships, and other news in brief: AC Immune, Avadel, Biocytogen, Merck KGaA, Novavax, Takeda, Xwpharma. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Agios, Aquestive, Arcutis, Boehringer Ingelheim, Eli Lilly, Pulmovant, Sol-Gel. Read More
