Winter is coming to the artificial intelligence industry. While it's springtime for investment and technological advancement, gray skies hover over the talent pool.
Astrazeneca plc's Farxiga (dapagliflozin), already the company's fifth best-selling product, now has a heart-failure component. The SGLT2 inhibitor met its phase III study's primary composite endpoint in reducing cardiovascular death or the worsening of heart failure compared to placebo in patients with reduced ejection fraction on standard-of-care treatment, including those with and without type 2 diabetes.
Interim results from Kalytera Therapeutics Inc.'s phase II open-label study of multiple doses of cannabidiol (CBD) in preventing acute graft-vs.-host disease (GVHD) were positive enough to persuade the company to skip enrolling the high-dose cohort and move directly to a phase III registration study.
What began a year and a half ago as a takeover of Impact Biomedicines Inc. ended Friday with FDA approval for the wholly owned Celgene Corp. subsidiary's rare bone marrow disorders drug, Inrebic (fedratinib).
The as-much-as-$15 million follow-on public offering proposed by Honolulu-based Cardax Inc. won't move the company off the island but it's designed to move it from the OCTQB to Nasdaq.
Phase III results for evinacumab from Regeneron Pharmaceuticals Inc. released Wednesday show a 49% LDL cholesterol reduction in patients with homozygous familial hypercholesterolemia (HoFH) when compared to lipid-reducing therapies alone.
The multiple months that typically separate a successful round of fundraising and entering the clinic are being brushed aside by Landos Biopharma Inc. as the company races toward two phase II trials following its just completed $60 million series B financing.
A choppy year for Amgen Inc. may be smoothing out after the U.S. District Court of New Jersey ruled that patents for Sandoz Inc.'s biosimilar, Erelzi (etanercept-szzs), a potential competitor to Amgen's highly lucrative arthritis treatment Enbrel (etanercept), should never have been granted.
The advisory committee meeting (adcom) that slowed progress for Amarin Corp. and its pending supplemental new drug application (sNDA) for expanding the labeling of Vascepa (icosapent ethyl) was a shock not only to the company but to investors, too, as the stock (NASDAQ:AMRN) took a battering Friday.
