DUBLIN – Can an investigational drug best known for reducing itch in dermatitis patients really lower the risk of COVID-19 patients progressing to acute respiratory distress syndrome (ARDS)? It might seem like a stretch, even in the midst of a pandemic, but New York’s largest health care provider, Manhasset-based Northwell Health, appears sufficiently convinced by the biological rationale to get behind a phase III trial of tradipitant, a neurokinin-1 (NK1) receptor blocker, which Washington-based Vanda Pharmaceuticals Inc. is already testing in phase III trials in atopic dermatitis, gastroparesis and motion sickness. Read More
The push in Congress to drive down U.S. prescription drug costs has taken a backseat to all things COVID-19, but that reprieve for drug companies may be about to end as freshman members of the House urge their leaders to include drug pricing proposals in the next coronavirus relief bill. Read More
San Francisco-based RDMD Inc. netted $14 million in series A money fueling an approach designed to generate clinical evidence that will speed drug development in rare diseases. Read More
Avectas Ltd., of Dublin, brought in a $20 million series C financing, ratcheting the total equity investment in the company to $40 million. Privately held Avectas, formed in 2012 as a spin-out from Ireland’s Maynooth University, said it plans to accelerate the clinical translation and commercial scale-up of its cell engineering technology and expand its staffing in Ireland. Read More
A recent Senate hearing raised the question of whether privacy and confidentiality are at risk when software is installed in smart devices for disease surveillance purposes, but there may be no absolute guarantee of confidentiality, jeopardizing the goodwill of citizens who are wary of big government. Read More
HONG KONG – South Korean biopharmaceutical company Kolon Tissuegene Inc. got a new lease on life as the U.S. FDA lifted the hold on the phase III trial for its lead candidate, Invossa-K (Invossa), for the treatment of osteoarthritis. Read More
Public drug and device companies may want to think twice before eagerly jumping on the COVID-19 bandwagon with announcements overselling their efforts to develop or repurpose products to treat patients infected with the coronavirus. Read More
Biopharmas raising money in public or private financings, including: Arcturus Therapeutics, Athersys, Calithera Biosciences, Evotec, Leon-nanodrugs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Actinium, Adial, Affimed, Amag, Biosig, Indivior, Inovio, Magenta, Novavax, Nucleus, PDS, Roivant, Sunovion, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alphamab, Ascendis, Autolus, Eagle, Emmaus, Index, Mayne, Mithra, Provention, Regeneron, Tetra, Tissuetech, Zai. Read More
