PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. announced that the FDA gave it the green light to test its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in patients with acute respiratory distress syndrome (ARDS) caused by coronavirus (COVID-19). “We’re going to be evaluating whether an injection of our cells intravenously can tone down the immune system just enough so it gets rid of the virus but doesn’t destroy your lungs at the same time,” Mesoblast CEO Silviu Itescu told BioWorld. Read More

HONG KONG – Another promising candidate has emerged in the race to find a treatment for the COVID-19 coronavirus. San Diego-based Ansun Biopharma Inc. released positive results from a four-patient study of its DAS-181 candidate, which is being developed for the treatment of severe COVID-19 infection.  Read More

NEW DELHI - In a bid to limit what is seen as excessive dependence on active pharmaceutical ingredients (APIs) from China, the Indian government has announced a $394 million scheme to promote the development of three bulk drug parks. Read More

COVID-19 has disrupted science in the way it has disrupted everything else. In the short term, universities have largely closed shop as a way to maximize social distancing, and lots of science – or at least, lots of bench work – is not getting done. Read More

HONG KONG – China’s I-Mab Biopharma Co. Ltd. has entered a strategic partnership with Indonesia’s PT Kalbe Genexine Biologics (KG Bio). Through the deal, KG Bio will receive the right of first negotiation to commercialize two I-Mab-discovered candidates in the ASEAN and MENA regions as well as Sri Lanka. Read More

Indian scientists have discovered a previously unknown mechanism underlying life-threatening sepsis and proposed a new treatment strategy centered upon cell-free chromatin (cfCh), they reported in the March 4, 2020, edition of PLOS ONE. Read More

PERTH, Australia –Australian stem cell therapy company Mesoblast Ltd. announced that the FDA has accepted its BLA for priority review for its allogeneic mesenchymal precursor cell therapy, remestemcel-L, for children with acute steroid-refractory graft-vs.-host disease (aGVHD). Read More

Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief, including: Adaptive, Alnylam, Amgen, Ansun, Assembly, Astellas, Aurobindo, Bioaegis, Bioardis, Bionomics, Brii, Capricor, Carterra, Celltrion, Celularity, Cytodyn, Diffusion, Eisai, Ennaid, Evotec, Evqlv, Flexion, Flugen, GSK, Ildong, Incyte, Innate, Innovation, Junshi, Kalos, Kleo, Lee's, Macromoltek, Mateon, Medincell, Modalis, Novartis, Noxopharm, Nuvo, Ocumension, Onxeo, Ostrich, Otsuka, Persephone, Premas, Primmune, Sanbio, Seikagaku, Seneca, Shenogen Pharma, Sirona, Sorrento, Takeda, Ultragenyx, Vaxart, Vir, Viscient, Voltron. Read More

Biopharmas in Asia-Pacific raising money in public or private financings, including: Propanc Biopharma. Read More

The latest global regulatory news, changes and updates affecting biopharma, including: Biotechnology Innovation Organization, Central Drugs Laboratory, Drugs Controller General, EMA, FDA, Gilead Sciences, Health and Human Services, Medicines and Healthcare Products Regulatory Agency, National Institute for Health and Care Excellence, Pfizer Healthcare India, Pharmaceuticals and Medical Devices Agency. Read More

Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Algernon, Ansun, Apeiron, Cytodyn, Eusa, Hutchison China Meditech, I-Mab, Inflarx, Inovio, Kiniksa, Nanocarrier, Novan, Oncoceutics, Sato, Synairgen, Vanda, VBL. Read More

Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Applied, Celularity, Cytodyn, Eisai, Faron, Gracell, I-Mab, Mallinckrodt, Mesoblast, Novoteris, Pharmamar, Revive, Takeda. Read More