New gene therapy treatments could add $45 billion to the cost of health care over the next five years, according to a new report from CVS Health Corp., of Woonsocket, R.I. While the number is staggering, without knowing the price of the currently unapproved therapies, how many patients will seek treatment and the likelihood of approval, the pharmacy benefit manager's estimate is basically an educated guess. Read More
The pending Abbvie Inc. merger with Allergan plc, expected to close in the first quarter, brought good tidings to another “A” company on Monday, allowing Astrazeneca plc to regain global rights to its late-stage Crohn’s disease and ulcerative colitis (UC) drug, brazikumab, an anti-IL-23 therapy that was out-licensed to Allergan in a $1.27 billion deal in 2016. Read More
LONDON – Researchers have discovered a T-cell receptor (TCR) that is both capable of targeting a range of solid tumors and independent of human leukocyte (HLA) type, opening up the prospect of developing a universal anticancer T-cell therapy. Read More
As attendees of last year’s American Society of Hematology (ASH) meeting heard, B-cell maturation antigen (BCMA)-targeting therapies are steadily gaining ground on various fronts, even as companies such as Springworks Therapeutics Inc. bring forward candidates that might boost activity of the class. Read More
Combination products with digital interfaces. Antibody-drug conjugates. Complex drugs. Synthetic biologics. They’re all examples of how technology is expanding the ambit of what’s considered a drug beyond the current U.S. binary regulatory system of small molecules and biologics. Read More
Biopharmas raising money in public or private financings, including: Adaptimmune, Arix, Beam, Quench Bio, Nanoviricides, Vaccibody, Zymeworks Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications, including: Anavex, Astellas, Astrazeneca, Aveo, Daiichi, Deinove, Epygenix, Evolus, Faron, Hansa, Innovation, Khondrian, Lilly, Nucana, Oncimmune, Oric, Sun Biopharma, Trovagene Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations, including: Affiris, Corium, Genentech, Merck, Neoimmunetech, Pharmacyte
The latest global regulatory news, changes and updates affecting biopharma, including: Emmaus Life Sciences Inc., Global Blood Therapeutics Inc., Novartis AG and Vyera Pharmaceuticals LLC Read More