Business as usual only three months ago has transformed into health care industry overdrive as biopharma and med-tech companies scramble to test and scale-up treatments, vaccines and diagnostics to address COVID-19. Read More
LONDON – COVID-19 excepted, biomedical research projects and clinical trials are grinding to a halt across Europe, as universities shut down and administrators stop any work not related to the coronavirus. Read More
Hoth Therapeutics Inc., of New York, and Voltron Therapeutics Inc. have formed a joint venture, Halovax, to develop a vaccine for COVID-19 that can be advanced to clinical testing. Read More
Humanigen Inc., the Burlingame, Calif.-based developer of an anti-human-GM-CSF monoclonal antibody for preventing and treating cytokine storms, is urgently working to spin up a phase III trial of the candidate, lenzilumab, for COVID-19 patients whose immune systems have gone into overdrive. Read More
HONG KONG – Korean biopharma Celltrion Inc. said it’s halfway through the process of creating a super antibody to reign in the COVID-19 novel coronavirus that has claimed almost 13,000 lives globally. Read More
BEIJING – Cancer and autoimmune specialist Innocare Pharma Ltd., of Beijing, made a strong debut to raise $288 million on the Hong Kong Stock Exchange (HKEX) on March 23, marking the second biggest IPO in the city since the beginning of this year. Read More
Stoke Therapeutics Inc. is marching ahead in the second half of this year with its phase I/IIa study with STK-001 in Dravet syndrome (DS), one of the more abysmal forms of epilepsy, although the FDA has temporarily hobbled part B of the test, pending preclinical data that will more fully characterize the safety profile of the antisense oligonucleotide (ASO). Read More
DUBLIN – For quite some time, cardiometabolic disease has been largely off the map for most small biotechs and for the venture capital investors that support them. Is that situation about to change? Maybe, maybe not was the mixed message arising from a Bio-Europe Spring 2020 virtual panel discussion on cardiometabolic disease. Read More
The Rare Disease Day, which takes place at the end of February each year, is designed to focus global attention on the need for therapies to treat patients suffering from devastating rare diseases. The most recent event represented the 13th year it has been held. Over that period, research and development in the area has come a long way, and there are now 420 companies around the world that are active in developing regenerative medicines and advanced therapies for the treatment of rare diseases, according to a new report released by the Alliance for Regenerative Medicine (ARM). Read More
Three candidates for FDA approval remain on BioWorld’s Drugs on Deck list for March, all of which have PDUFA dates scheduled for this month, even though most of the agency’s attention as of late is on the COVID-19 pandemic. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Cyclo, Cytodyn, Forty Seven, Humanigen, Novan, Irlab, Obseva, Pliant, Roche, Vaccitech.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agios, Anheart, Arch, Biohaven, Bone, Can-Fite, Eiger, Genentech, Helsinn, Lilly, Stoke. Read More
