Hospira Inc. has reached a major milestone in the development of the biosimilar drugs market by gaining formal European Commission approval for Europe’s first biosimilar monoclonal antibody, Inflectra (infliximab), which is based on the blockbuster TNF-alpha inhibitor Remicade (infliximab). It represents the first major dent in the armor of the biotechnology industry’s most valuable franchise. Read More
Panelists on the FDA’s Pulmonary-Allergy Drugs Advisory Committee that convened to decide about Anoro Ellipta, the inhaler product for chronic obstructive pulmonary disease (COPD), proved harder to satisfy than briefing documents might have led Glaxosmithkline plc (GSK) and partner Theravance Inc. to expect. Read More
Verastem Inc. demonstrated that lead candidate defactinib (VS-6063) remains on the fast track by initiating what it called a “registration-directed” trial of the cancer stem cell inhibitor in malignant pleural mesothelioma. The global, double-blind, placebo-controlled COMMAND (Control Of Mesothelioma with MAiNtenance Defactinib) trial plans to enroll 350 to 400 patients, with primary endpoints of progression-free survival (PFS) and overall survival (OS). Read More
What if a child were playing on the train tracks? What if there were a nuclear accident on the coastline? What if a safe were falling from the sky? The Pediatric Ethics Subcommittee of the FDA spent a second day of meetings deliberating on the questions posed by the agency, informed by speaker presentations from the previous day. Read More
Basel, Switzerland-based Roche AG is partnering with Inovio Pharmaceuticals Inc. and will develop DNA-based vaccines INO-5150, targeting prostate cancer, and INO-1800, targeting hepatitis B. Read More
LONDON – Kiadis Pharma BV announced positive results in a five-year follow-up of the Phase I/II study of ATIR, a cell therapy for enabling hematopoietic stem cell transplants from non-identical donors. Read More
LONDON – Delivering synthetic messenger RNA that encodes the right growth factor directly to the heart muscle shortly after a heart attack can induce heart stem cells to divide and mature into new blood vessels, a new study has shown. Mice treated in that way showed a long-term increase in survival. Read More
• Nanoviricides Inc., of West Haven, Conn., said it met the listing standards of major U.S. stock exchanges after executing a 1-for-3.5 reverse split of its issued and outstanding common stock on Sept. 9, reflected at the opening of the Over-the-Counter Bulletin Board on Tuesday. Read More
• Bayer Healthcare, of Whippany, N.J., a unit of Bayer AG, said it entered a strategic alliance with the Broad Institute in Cambridge, Mass., in the area of oncogenomics and drug discovery. Read More
• Xenoport Inc., of Santa Clara, Calif., said it will advance XP23829, a fumaric acid ester compound that is a prodrug of monomethyl fumarate (MMF), in relapsing-remitting multiple sclerosis and/or psoriasis following positive preliminary results from two Phase I studies. Read More
• Dipexium Pharmaceuticals LLC, of New York, made modifications to the formulation of Locilex (pexiganan acetate cream 1 percent), resulting in favorable chemical and physical stability according to an 18-month stability test by the manufacturer showing that it has a shelf life of at least 36 months at room temperature. Read More
