The devastating societal and economic effects caused by the ongoing COVID-19 pandemic should sound a warning bell on how ill-prepared we are in our ability to fight lethal infectious diseases for which no effective therapies or vaccines currently exist. Indirectly, the intense public attention on companies that are engaged in developing COVID-19 cures is also spilling over to companies researching to uncover new anti-infectives that will be needed to replace the diminishing arsenal of effective therapies to combat drug-resistant bacteria and fungi. This is certainly evident among public companies in the space, with the BioWorld Infectious Diseases index showing an increasing upward trend since the beginning of the year. At market close on May 11, the index had, in fact, grown in value by a whopping 47%. Read More
The May 12 Senate hearing regarding the COVID-19 pandemic included the usual conversations about contact tracing, but Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he is “cautiously optimistic” that one of the vaccines currently in trial in the U.S. will work, but that it is unlikely a vaccine will be ready by September 2020. In contrast, Assistant Secretary for Health Brett Giroir said testing capacity may reach 50 million tests per month by that time, thanks in part to the fact that antigen testing is now part of the FDA’s emergency use authorization mechanism. Read More
DUBLIN – The Innovative Medicines Initiative (IMI), a public-private research partnership between the European Commission (EC) and Europe’s pharmaceutical industry, has boosted funding for a fast-track response to the COVID-19 pandemic from €45 million (US$48.8 million) to €72 million. Read More
Two companies developing nonalcoholic steatohepatitis (NASH) therapies found themselves at opposite ends of the spectrum Tuesday, with Cymabay Therapeutics Inc. potentially getting a second chance while the door slammed on Genfit SA’s hopes. Read More
BEIJING – Androgen receptor (AR)-related disease specialist Kintor Pharmaceutical Ltd., of Suzhou, China, is looking to raise up to HK$1.861 billion (US$240 million) in a Hong Kong IPO to advance its small-molecule AR antagonists, proxalutamide and pyrilutamide, both of which have first- and best-in-class potential. Read More
Kriya Therapeutics Inc., a startup led by former Axovant Sciences Inc. executive Shankar Ramaswamy, has raised $80 million in series A financing expected to help advance a portfolio of gene therapies for diabetes and other chronic conditions. Read More
HONG KONG – Singapore-based Proteona Pte. Ltd. has started a partnership to characterize the clinical response to a new COVID-19 vaccine, with clinical trials soon to start at Flinders Medical Centre testing the candidate developed in collaboration with Adelaide, Australia-based Vaxine Pty Ltd. Read More
Innovation is being rewarded under Medicare’s proposed fiscal 2021 Inpatient Prospective Payment System (IPPS) that was unveiled Monday. For starters, the Centers for Medicare and Medicaid Services (CMS) is proposing a new Medicare-severity-diagnosis related group (MS-DRG) specifically for CAR T therapies. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Galderma, Galera, Gamida, Genfit, Glenmark, Marker, Minoryx, Neurana, Ocular Therapeutix, Rocket, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alpha Cognition, Histogen, Moderna, Seattle Genetics. Read More
