Since the stock-jolting phase III blowup in March of Milestone Pharmaceuticals Inc.’s etripamil for paroxysmal supraventricular tachycardia (PSVT), questions have lingered regarding the short-acting channel blocker’s regulatory path forward – but no longer. Shares of Montreal-based Milestone (NASDAQ:MIST), which in the spring plummeted to an all-time low of $1.70, made up for the loss and then some, closing at $8.91, up $5.57, or 167%, on word that the FDA has agreed to terms whereby an NDA for the nasal spray may be submitted without launching another phase III study. Read More
The FDA has lifted all the clinical holds it placed on seladelpar from Cymabay Therapeutics Inc. for INDs in nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC) and primary sclerosing cholangitis, giving the company new hope. Read More
Although PDUFA VI still has two years of life left to it, PDUFA VII is already in the birthing process, with the use of real-world data (RWD), AI, and a coming surge of novel cell and gene therapies looking to be prominent features of the next five-year user fee agreement. Politics likely will play a role as well. Read More
In the shadow of COVID-19, experts at the BIO Asia-Taiwan conference on Wednesday warned of present and future challenges for the biotech industry. Changes in manufacturing logistics and financial distress will continue to cause concern for the industry. Read More
Cancer treatment has been transformed, at its root, by a transformational change in how it is classified. These days, which organ a tumor arises in is often less important than its molecular drivers, which can be sensitive either to specific targeted treatments, or increase the chance that a tumor will respond to immunotherapy. Those successes have not escaped the notice of researchers in other areas of biomedicine, and diseases including heart failure, asthma and polycystic ovarian syndrome are being looked at with an eye to subdividing them in ways that brings diagnostics into the molecular era. Nowhere do those changes have greater potential than in disorders of the brain – in part because there is nowhere much to go but up as far as classifying neurological diseases goes. Read More
HONG KONG – Daejeon, South Korea-based biotechnology company G2GBIO Inc. has raised ₩11.4 billion (US$9.53 million) from a series B financing round, with the funds to be used on clinical trials for a sustained-release Alzheimer’s treatment as well as nonclinical trials for diabetes and sustained-release postoperative pain treatments. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Ampio, Aravive, Clarity, Corcept, Genfit, Incyte, Pipeline, Quadriga. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adial, Cymabay, Elsalys, Inotrem, Milestone, Neumentum, Vita. Read More
