LONDON – The World Health Organization (WHO) has officially declared COVID-19 a pandemic, but is pushing back strongly against countries giving up on stringent control measures. Read More
U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings. Read More
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. plans to evaluate its allogeneic mesenchymal stem cell (MSC) candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19) in the U.S., Australia, China and Europe. Read More
Privately held Silverback Therapeutics Inc. continued its drive toward the clinic with an oversubscribed series B financing of $78.5 million to support its lead candidate, an anti-HER2 antibody conjugated to a TLR8 agonist for treating moderate or high HER2-expressing solid tumors. Read More
CYBERSPACE – Continuing improvements in HIV treatment and progress toward a cure notwithstanding, an effective vaccine will be necessary to gain the upper hand in the decades-long fight against the pandemic. Read More
In a second phase III trial for treating progressive forms of multiple sclerosis (MS), designed to confirm the successful first trial, Medday Pharmaceuticals SA’s investigational MD-1003 failed to hit its primary and secondary endpoints. Read More
Taking a breather from the political rhetoric that’s permeated the U.S response to COVID-19 and pushed legislation aimed at lowering drug prices to the back burner, a House subcommittee Wednesday advanced several bipartisan bills intended to improve the safety and ensure the supply of drugs and medical devices. Read More
PERTH, Australia – While the coronavirus captures the world’s attention, another global pandemic is quietly killing 100 million people under the age of 60, and Australian investors are putting up AU$53 million (US$34.58 million) to back late-stage projects at the George Institute for Global Health. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Janssen, Newron, Paratek, Seelos, Spero. Read More
