Conditionally active antibody specialist Cytomx Therapeutics Inc. has agreed to work with Regeneron Pharmaceuticals Inc. to discover and develop new bispecific antibodies with what the partners said is the potential to "widen the therapeutic window and help minimize off-target effects." Read More
With a 9-4 vote, the U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee bucked FDA reviewers who delayed PDUFA dates, issued a complete response letter and two formal dispute resolution requests for Ardelyx Inc.’s tenapanor as a hyperphosphatemia therapy for adults on dialysis with chronic kidney disease (CKD). Read More
A lackluster efficacy signal has prompted Editas Medicine Inc. to pause enrollment in a phase I/II trial of its CRISPR/Cas9-based gene editing therapy, EDIT-101, which is in development for patients with a particular form of Leber congenital amaurosis type 10. Read More
Astellas Pharma Inc.’s zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint of progression-free survival in the phase III Spotlight trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, according to top-line data. Read More
Fundamental Pharma GmbH has raised €10 million (US$10.3 million) in a seed round to develop a new class of glutamate inhibitors, after uncovering a route to maintaining the protective effects of the neurotransmitter in the synapses while preventing neurotoxicity when it is released elsewhere. Read More
An uptick in positive clinical data reported in recent months has helped nudge the BioWorld Biopharmaceutical Index (BBI) to its highest point this year. BBI is up by 15.58%, significantly higher than the 1.36% increase recorded at the end of August, just as statistically significant clinical results began to roll in from a number of biopharma companies. Read More
Simcere Pharmaceutical Group Ltd. has inked a licensing agreement picking rights to develop Idorsia Ltd.’s insomnia treatment in greater China, in exchange for a $30 million up-front payment. Read More
Social scientists are well aware of the consequences of what’s called assortative mating – that is, the fact that marriages tend to occur between people who are similar in things such as interests, social status, education and wealth. Biologists, on the other hand, have tended to ignore it. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apollomics, Ascletis, Canbridge, Depymed, Neurosense. Read More
