Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Agastiya, Aptose, Aribio, Astrazeneca, Beigene, Coherus, Daiichi Sankyo, Hutchmed, Jiangsu Recbio Technology, Johnson & Johnson, Junshi, Moderna, Newsoara, Novavax, Palisade, Very, Vopec.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Betta, Botanix, Brickell, Brii, Cannvalate, Clover, Eyepoint, Hansoh, Helsinn, Insilico Medicine, Jemincare, Juniper Biologics, Lanova Medicines, Microba Life Sciences, Nikang, Olix, Orion, Storm, Tetra, Turning Point.
Askgene Pharma Inc., which less than two weeks ago reported positive initial data from an ongoing phase I/II trial testing its claudin 18.2-targeting candidate, ASKB-589, added $20 million in a series A round, intended to advance the company’s clinical pipeline and support further development of its Smartkine cytokine drug platform.
As the American Society of Clinical Oncology meeting nears, presenters are talking up their prospects, including Biomea Fusion Inc. with early data from experiments testing BMF-219, an oral, irreversible covalent menin inhibitor – one in an intriguing class that has sparked efforts by various developers.
For the first time since the early weeks of the COVID-19 pandemic in 2020, global deaths caused by the disease have fallen to their lowest point, as immunity against the SARS-CoV-2 virus and its variants continues to build. Infections and deaths appear to be decelerating, an optimistic sign that the pandemic may be nearing an end.
IPOs continue to be sluggish but two companies, Pepgen Inc. and Bausch & Lomb Corp., that began trading May 6 managed to sidestep the turbulence despite having to lower their expectations before the market opened.
A proposal hammered out by the EU, India, South Africa and the U.S. to allow IP waivers for COVID-19 vaccines is headed to all members of the World Trade Organization (WTO) for consideration.