Partners Amgen Inc. and Allergan plc said the phase III study of ABP 215 – a biosimilars candidate to Avastin (bevacizumab, Genentech Inc./Roche AG) and the first in the oncology collaboration to complete a late-stage trial – met its primary and secondary endpoints in comparing efficacy and safety to the reference drug in adults with advanced non-squamous non-small-cell lung cancer (NSCLC). Read More
LONDON – After a slow start following the first approval in 2006, adoption of biosimilars in Europe is now picking up pace in the face of pressure from payers, increased understanding by physicians and the availability of more products addressing underserved patient populations. Read More
What one analyst described as Heron Therapeutics Inc.'s "profound benefit" in phase II data with HTX-011 for post-bunionectomy pain triggered speculation about how the findings might translate into a pivotal trial with the compound, a long-acting formulation of the numbing agent bupivacaine in a fixed-dose pairing with the anti-inflammatory therapy meloxicam. Read More
With multiple midstage trials ongoing of apatorsen in several cancer types, Oncogenex Pharmaceuticals Inc. is unlikely to spend too much time ruminating on the failure of the phase II Ranier trial testing the drug, formerly known as OGX-427, in pancreatic cancer, an arguably long-shot indication from the start. Read More
Regenxbio Inc., of Rockville, Md., closed its IPO of 7.245 million shares of common stock at $22 per share, which included 945,000 shares of common stock issued upon the full exercise by the underwriters of their option to purchase additional shares. Read More
Hemispherx Biopharma Inc., of Philadelphia, said authors of a peer-reviewed article published in Clinical and Cellular Immunology observed that Ampligen, a Toll-like receptor 3 (TLR3) agonist, unlike all other Toll-like receptors studied to date, has a mechanism of action making it potentially adaptable as a treatment for disorders such as multiple sclerosis (MS). Read More
Provectus Biopharmaceuticals Inc., of Knoxville, Tenn., completed development of the protocol for a phase Ib/II trial of its investigational cancer therapy PV-10 in combination with the anti-PD-1 immune checkpoint inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with stage IV melanoma. Read More
