Just months after Jazz Pharmaceuticals plc's inventory of a therapy key to treating certain acute lymphoblastic leukemia and lymphoblastic lymphoma patients appears to have run out, FDA approval has arrived for an alternative: a recombinant version of the medicine the company developed, Rylaze (asparaginase Erwinia chrysanthemi (recombinant)). Read More
New top-line data from Kintara Therapeutics Inc.’s phase II study of its lead candidate, VAL-083, in recurrent glioblastoma multiforme were incrementally better than data released in April, and that’s just fine with CEO Saiid Zarrabian. “Normally, in my experience, top-line data usually regresses a little,” Zarrabian told BioWorld. “The fact that it improved could be a reflection of the small size of the study, but it adds a little more interest to top-line data.” Read More
Beigene Ltd. got the green light for an IPO on the Shanghai Stock Exchange’s Science and Technology Innovation Board, a specialized board known as the STAR Market, that could be worth around $3 billion. It would make Beigene the first biotech company with listings in the U.S., Hong Kong and mainland China. Read More
Glaxosmithkline plc should stick to its plan to split into two companies, one focused on pharma and the other on consumer health, but must ask itself whether CEO Emma Walmsley is the right person to lead the changes, according to activist investor Elliott Management. Read More
Researchers have identified an evolutionarily conserved metabolic role for tissue-resident macrophages, they reported in the July 2, 2021, issue of Science. In a commentary published alongside the paper, Conan O’Brien and Ana Domingos from the University of Oxford asserted that the work “introduces a new, macrophage-centered paradigm in… energy storage.” Read More
As confirmed cases and deaths from COVID-19 continue their downward slide, biopharma research efforts remain front and center, providing a new therapeutic for emergency use in the U.S. and high-efficacy phase III data for what could become the country’s fourth vaccine and its first protein subunit option. Read More
The COVID-19 vaccine from Curevac AG looks far less protective than mRNA-based rivals, according to phase IIb/III data, but the company suggested it could still be approved in younger age groups or supplied to poorer countries at lower cost. Read More
As life begins to return to a semblance of normal in many parts of the world, COVAX cautioned countries July 1 against adopting policies that favor specific COVID-19 vaccines. Read More
The World Health Organization’s (WHO) guidance for ethics and governance for artificial intelligence (AI) in health discusses several issues regarding regulation, including the question of transparency for the algorithm’s source code. The WHO paper is not prescriptive on this and several other issues, however, raising the prospect that regulatory entities will not be discouraged from adopting policies that run afoul of intellectual property concerns and thus impede advances in AI. Read More
Biopharmas raising money in public or private financings, including: Absci, Acumen, Aligos, Bone, Graphite, Healthcare Royalty, Kymera, Pfizer, Point, Sirnaomics, Spero, Therapeutics Acquisition. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Direct, Emergex, Lexeo, Solasia. Read More
