Valeant Pharmaceuticals International Inc., which last year decided to pick up the brodalumab torch dropped by Amgen Inc., now faces its reckoning with the FDA.
One of the biggest shortcomings in cancer treatment is the inability, in many cases, to find and attack cancer cells that survive traditional chemotherapy. Biopharma has thrown a variety of weapons at the enemy, from combination regimens to targeted drugs, but with the need still evident, Vivolux AB is taking another approach: eliminating the stray cells by cutting off their power supply.
Ultragenyx Pharmaceutical Inc. enrolled only 12 patients in the pivotal phase III study of its recombinant human beta-glucuronidase (rhGUS) candidate, also known as UX003, to treat ultra-rare mucopolysaccharidosis 7 (MPS 7), or Sly syndrome.
A strong development pipeline for regenerative medicine (RM) therapies designed to treat a range of unmet medical needs suggests the potential for rapid growth in global sales of products that could offer significant benefits to public health, according to an analysis by the Tufts Center for the Study of Drug Development (CSDD).
Bayer AG and privately held X-Chem Inc. expanded their global drug discovery collaboration, initiated in 2012, to encompass the entire bandwidth of therapeutic areas and target classes from Bayer's R&D pipeline.
In what Henry Ji, president and CEO of Sorrento Therapeutics Inc., called a "validating deal" for its immuno-oncology (I-O) platform, the company inked an exclusive global license and collaboration agreement with Les Laboratoires Servier SAS for its fully human anti-PD-1 monoclonal antibody (MAb), STI-A1110, that could add a multiplier to the disclosed potential of €886 million (US$979.8 million).
Officials at Galena Biopharma Inc. are still in the dark on data from the phase III PRESENT trial of cancer vaccine Neuvax (nelipepimut-S), company president and CEO Mark Schwartz revealed Friday on a conference call with analysts.
With the two-day meeting of the FDA's Arthritis Advisory Committee (adcom) scheduled to convene next week to address biologics license applications for two biosimilar candidates, companies jockeyed for position by presenting data on related indications at Psoriasis 2016, the 5th Congress of the Psoriasis International Network in Paris.
Andrew Gomperts, president and CEO of Hillhurst Biopharmaceuticals Inc., readily admits the San Diego-based company is "standing on the shoulders of giants" in its quest to translate the potential of five decades of research on the heme oxygenase (HO) pathway into therapeutic agents for sickle cell disease, cerebral injury and other inflammatory conditions such as multiple sclerosis.
A fully human antibody targeting interleukin (IL)-8 that wound its way through Medarex Inc. and Genmab A/S has found a new home at Bristol-Myers Squibb Co. (BMS) through the acquisition of Cormorant Pharmaceuticals AB.
