WASHINGTON – The FDA's blessing Friday of the world's first clinical trial of a human embryonic stem cell (hESC) therapy has not only launched what may be "the dawn of a new era" for medical treatment, but if successful, the therapies could alleviate much of the burdensome costs plaguing the nation's health care system, insisted Geron Corp. CEO Thomas Okarma. (BioWorld Today)
WASHINGTON – Tuesday's trading reflected investors' relief for Amgen Inc., ambiguity about Genzyme Corp. and anxiety over AMAG Pharmaceuticals Inc. on Medicare's release of the final rules governing payments for dialysis services for beneficiaries with end-stage renal disease (ESRD). (BioWorld Today)
Onyx Pharmaceuticals Inc.'s investors were fired up Monday over top-line Phase IIb data that showed patients with relapsed-refractory multiple myeloma receiving carfilzomib as a single agent had an overall response rate of 24 percent, with a median duration of response of 7.4 months and no new or unexpected toxicities. (BioWorld Today)
Adhering to the advice of a May panel of rheumatologists and drug safety experts, the FDA has refused to approve NicOx SA's experimental osteoarthritis drug naproxcinod until more studies are completed, which sent the French drugmaker's stock into a tailspin Thursday. (BioWorld Today)