Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Bayer, Biogen, Can-Fite, Capricor, Denovo, Eisai, Leads, Neurosense, Neuvivo, Novavax, Ocugen, Soleno, Teva, Zealand.
SK Bioscience Co. Ltd., of Seongnam-si, South Korea, said Oct. 8 that it will acquire a $3 million stake in Fina Biosolutions LLC to become the first and sole strategic investor of the Rockville, Md.-based vaccine specialist. For SK Bioscience, the investment is slated to boost its vaccine R&D capabilities, the company said, which currently includes manufacturing of pneumococcal and typhoid conjugate vaccines.
The Japanese government is throwing full weight behind the Bioeconomy Strategy initiative to position Japan’s biopharmaceutical industry as both a key driver of economic growth and global drug discovery hub.
With confidence dropping in doing business with China-affiliated life sciences companies due to the Biosecure Act, one of the companies explicitly named in the U.S. legislation is fighting back. Raising the possibility of a constitutional challenge to the bill, Rade Drmanac, co-founder and chief scientific officer of Complete Genomics Inc., wrote to congressional leaders to urge them to remove the California-based subsidiary of MGI from the bill.
The U.S. FDA has issued yet another complete response letter (CRL) for dasiglucagon, a glucagon receptor agonist, being developed by Zealand Pharma A/S for treating congenital hyperinsulinism, an ultra-rare disease that is also being targeted by at least two other companies. This CRL is pegged to the timing of a third-party manufacturing facility reinspection that was done in August and September. The agency also wants some additional clinical analysis from the phase III study.
Purespring Therapeutics Ltd. has raised £80 million (US$104.6 million) in a series B, putting it on course to be the first to take a gene therapy for a kidney disease into the clinic. The money enables the company to move the lead program, PS-002, for the treatment of IgA nephropathy to clinical proof of concept and advance programs in other complement-mediated kidney diseases, and in an undisclosed glomerular kidney disease.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aosaikang, Autonomous, Bayer, Black Diamond, Innovent, Lipocine, Mink, Moma, Pharmalink, Pharmanovia, Siga, Tonix, Zambon.
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