HONG KONG – The Japanese government is tightening its grip on its listed companies, including those working on promising COVID-19 treatments. On May 8, the Japanese Ministry of Finance released a list of 518 companies that would be subject to stricter restrictions on receiving foreign investments.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 9 Meters, Appili, Astrazeneca, Bellerophon, Crispr, Daiichi, Histogen, Lilly, Merck, Relief, Tracon, Vertex.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Pharma, Infinity, Kiniksa, Lilly, Merck, Myokardia, Oyster Point, Protalix, Strongbridge, Tolerogenixx.
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
In the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amgen, Arch, Bridge, Cynata, Cytokinetics, Junshi, Pluristem, Redhill, Sesen, Takeda.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acadia, Arcturus, Beroni, Fortress, Oncogenuity, Sorrento, Zyus.