Payday came right on time for NPS Pharmaceuticals Inc. and recent acquirer Shire plc with FDA approval of Natpara, a recombinant human parathyroid hormone (PTH), as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Read More
With the FDA's approval as expected of Rockwell Medical Inc.'s iron-replacement drug Triferic (soluble ferric pyrophosphate), the talk turned to sales forecasts, and the Wixom, Mich.-based company's optimism was called into question by Brean Capital Markets LLC analyst Jonathan Aschoff, who characterized as "dismal" the compound's prospects. Read More
HONG KONG – The identification of a promising novel candidate therapeutic target in non-small-cell lung cancer (NSCLC) tissue by Chinese researchers could lead to the development of urgently needed new lung cancer immunotherapies. Read More
While the PD-1 pathway has garnered most of the attention in the checkpoint inhibition space so far, thanks to last year's approvals of Keytruda (pembrolizumab, Merck & Co. Inc.) and Opdivo (nivolumab, Bristol-Myers Squibb Co.), a 2010 Israeli start-up is advancing what appears to be a first-in-class compound against a new immune checkpoint protein. Read More
Simply accelerating FDA review of new drugs and devices is not the answer to providing sought-after cures for the 21st century. What's needed is more collaboration among industry, the FDA and consumers, according to a new report by the PWC Health Research Institute. Read More
Forbion Capital Partners, a Dutch life-sciences venture capital firm, said it led the closing of a C$13.5 million (US$10.85 million) series B financing round for Engene Inc., of Vancouver, Brish Columbia, with a syndicate of life science investors including existing shareholder, Merck Lumira Biosciences Fund, and new investors, Fonds de Solidarité FTQ and Inbio Ventures (Luxembourg). Read More
Biocryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said the FDA has granted fast track designation for BCX4161, an orally administered, selective inhibitor of plasma kallikrein in advanced clinical development for the treatment of hereditary angioedema. Read More
Synageva Biopharma Corp., of Lexington, Mass., began dosing dosing with SBC-103 in patients with mucopolysaccharidosis IIIB, also known as Sanfilippo B syndrome, as part of a phase I/II study. The study will enroll about nine patients older than 2 years and younger than 12 with definitive diagnosis of MPS IIIB and developmental delay. Read More
ALK-Abello A/S, of Copenhagen, Denmark, said partner Torii Pharmaceutical Co. Ltd., of Tokyo, has submitted a new drug application in Japan for ALK's house dust mite sublingual allergy immunotherapy tablet for the indication of allergic rhinitis. Read More
Ipsen SA, of Paris, disclosed top-line results for two double-blind phase III studies of Dysport (abobotulinumtoxin A) in pediatric lower limb (PLL) spasticity in children with cerebral palsy and in adult lower limb (ALL) spasticity in patients who had experienced a stroke or traumatic brain injury. Read More
