Regado Biosciences Inc.'s double-punch anticoagulant took one on the chin from Wall Street, as investors learned about an unplanned review by the data safety monitoring board (DSMB) of the phase III trial testing the drug previously known as REG1 in patients undergoing percutaneous coronary intervention (PCI). Read More
More than a month ahead of its scheduled PDUFA date, the FDA granted conditional approval for Spectrum Pharmaceuticals Inc.'s in-licensed peripheral T-cell lymphoma (PTCL) therapy, Beleodaq (belinostat), triggering a $25 million payment to the drug's owner, Topotarget A/S, and giving patients and doctors a new weapon against the fatal disease. Read More
With fast track FDA status for its lead compound against fibrosis in Duchenne muscular dystrophy (DMD) and new financial support from the main disease association through a philanthropy program based on promising preliminary phase Ib/IIa data with oral HT-100 (delayed-release halofuginone), Akashi Therapeutics Inc. takes its place in the race for a new DMD therapy. Read More
As increasing bacterial drug resistance threatens to usher in a post-antibiotic era, one strategy being explored is so-called host-directed therapy – trying to give the immune system of an infected person a leg up against what ails them. Read More
Viking Therapeutics Inc. became the fourth biopharma during first three days of the third quarter to indicate its intention to plumb the public markets with an initial public offering (IPO). San Diego-based Viking filed an S-1 with the SEC seeking to raise up to $57.5 million, including overallotments, for the offering, which is not yet priced. Read More
LONDON – Faults in the process by which cells in the brain remove debris may lie at the heart of several different neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS). Read More
Aiming to help bridge the gaps in early stage funding, Johnson & Johnson is setting up a network of innovation centers to advance programs across a range of therapeutics, medical devices, diagnostics and consumer health care applications. Read More
Genmab A/S, of Copenhagen, and Glaxosmithkline plc, of London, said they received marketing authorization from the European Commission to use Arzerra (ofatumumab), a human monoclonal antibody against CD20, in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukemia who have not received prior therapy and who are not eligible for fludarabine-based therapy. Read More
Summit plc, of Oxford, UK, said the first patients were dosed in its phase II proof-of-concept trial testing oral antibiotic SMT19969 for the treatment of Clostridium difficile infection (CDI). Read More
Astrazeneca plc, of London, and technology transfer organization MRC Technology said they renewed their strategic collaboration, which focuses on the identification and selection of drug targets with the potential to become potent and selective therapeutics against disease areas such as oncology, inflammation and diabetes. Read More
