Shield Therapeutics plc, of London, said it completed enrollment of the pivotal phase III AEGIS-CKD study of European-marketed drug Feraccru (ferric maltol), with top-line data, based on the 16-week primary endpoint, anticipated early in the first quarter of 2018. Read More
The Broad Institute of MIT and Harvard University in Cambridge, Mass., and Deerfield Management in New York, disclosed the launch of a research partnership, aimed at solving therapeutic challenges related to serious unmet medical needs. Read More
Spectrum Pharmaceuticals Inc., of Henderson, Nev., said it entered separate, privately negotiated exchange agreements with certain holders of its 2.75 percent convertible senior notes due Dec. 15, 2018. Read More
Biocon Ltd. said Tuesday the FDA issued a complete response letter (CRL) for partner Mylan NV's BLA for MYL-1401H, a proposed biosimilar of Amgen Inc.'s Neulasta (pegfilgrastim), the latest biosimilar version of the long-acting G-CSF drug to hit a regulatory snag. Read More
Seattle Genetics Inc. shared progress on two key development programs Tuesday, dosing the first patient in a registrational phase II study of enfortumab vedotin (EV) for locally advanced or metastatic urothelial cancer and initiating a new phase II study of tisotumab vedotin (TV) in patients with advanced cervical cancer. Read More
Shares of Kalvista Pharmaceuticals Inc. (NASDAQ:KALV) soared to $15.80 – the high water mark since the company's reverse merger last year with Carbylan Therapeutics Inc. – and closed at $10.19 for a gain of $2.81 after Merck & Co. Inc. agreed to pay a $37 million nonrefundable up-front fee and up to $715 million in milestone payments as part of a collaboration to advance KVD-001, an intravitreal (IVT) injection candidate to treat diabetic macular edema (DME). Read More
Anaptysbio Inc.'s phase IIa interim data win with intravenous (I.V.) ANB-020, the antibody targeting interleukin-33 (IL-33) for eczema, touched off speculation about competitors working in the same pathway, as the firm's shares (NASDAQ:ANAB) climbed 101 percent, or $35.41, to close Tuesday at $70.41. Read More
DUBLIN – Turnstone Biologics Inc. entered a research, option and license agreement with Abbvie Inc., which it claims is the biggest such deal on record in the rapidly emerging area of oncolytic viruses. Read More
Looking for insight, a lot of eyes will be watching Thursday as Spark Therapeutics Inc. makes its debut appearance before an FDA advisory committee. Read More
