Invivo Therapeutics Holdings Corp., of Cambridge, Mass., said Goodman Campbell Brain and Spine in Indianapolis has been added as a clinical site in the company's ongoing pilot study of its Neuro-Spinal Scaffold in patients with acute spinal cord injury. Read More
Dicerna Pharmaceuticals Inc., of Cambridge, Mass., said it initiated a proposed underwritten public offering of 2.75 million shares of common stock and will grant the underwriters a 30-day option to purchase up to an additional 412,500 shares of common stock. Read More
NEW DELHI – With three new vaccines in the pipeline over the next two years – for viruses that are common in developing tropical countries – India-based Bharat Biotech International Ltd. (BBIL) continues to pursue its defining mantra of a $1-a-dose vaccine that is within the reach of people in poor countries. Read More
As the race heats up to translate promising human gene-editing technologies from the academic lab to human trials, U.S. policy advisers are trying to catch up with the research to answer questions about potential risks and ethical concerns. Read More
LONDON – Psioxus Ltd. has raised £25 million (US$38.5 million) in a series C round that will enable the company to fund a phase I trial of its oncolytic virus enadenotucirev (Enad) in combination with an immune checkpoint inhibitor. Read More
Aiming to become what CEO Milind Deshpande called "part of the inner circle" in hepatitis C virus (HCV) therapies, Achillion Pharmaceuticals Inc. sealed a potential $1.1 billion deal with Johnson & Johnson unit Janssen Pharmaceuticals Inc., plus an equity investment of $225 million from the pharma heavyweight, which already has a footprint in the disease with Olysio (simeprevir), an NS3/4A protease inhibitor (PI) first cleared by the FDA in 2013. Read More
ATLANTA – Just because we can, should we? One of humanity's age-old questions took center stage at the two-day BEINGS 2015 meeting, during which delegates began laying the groundwork for what is hoped to become a consensus document setting ethical principles, policies and guidelines in the area of cellular biotechnology, which includes stem cell science and the rapidly advancing gene-editing technologies. Read More
Belgium's Celyad SA (formerly Cardio3 Biosciences SA) followed the footsteps of its European biotech brethren by filing with the SEC for a U.S. IPO. Read More
"Excited about getting some more alignment and taking some unknowns out of the equation" as it pertains to the path market-ward, CEO Nick Leschly said Bluebird Bio Inc. will consider bringing on a partner to help with Lentiglobin BB305 for beta-thalassemia major "if it makes sense for capabilities, ideally not for finances." Read More
Following extensive talks with the FDA and European regulators, Intercept Pharmaceuticals Inc. has nailed down plans for a rigorous pivotal phase III study testing obeticholic acid (OCA), the company's lead candidate, in about 2,500 patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis, a population representing potentially more than 14 million patients in the U.S. alone. Read More
