BEIJING – Chinese regulators granted the marketing nod to Beijing-based Beigene Ltd.‘s PD-1 antibody, tislelizumab, for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. To be sold under the Chinese trade name Baize’an, tislelizumab is Beigene’s first drug to win approval in China, following an FDA approval for its BTK inhibitor, Brukinsa (zanubrutinib), last month. “We are preparing the commercialization of tislelizumab, and we will start supplying the drug soon,” Beigene’s media relations officer, Min Xiao, told BioWorld Asia.
BEIJING – Chinese scientist He Jiankui has been sentenced to three years in prison and fined ¥3 million (US$429,421) for illegally carrying out the human embryo gene editing that led to the birth of twin girls and another baby with heritable changes to their genomes.
PERTH, Australia – On the heels of a $1.15 billion deal between Roche Holding AG and Sarepta Therapeutics Inc. for Sarepta’s gene therapy to treat Duchenne muscular dystrophy (DMD), another therapy to treat DMD is emerging from Down Under.
Astellas Pharma Inc.’s early 2018 buyout of Universal Cells Inc. (UC) may have laid the groundwork for longer-range steps in allogeneic CAR T-cell therapy, but Xyphos Biosciences Inc. CEO James Knighton told BioWorld Asia that the buyout of his firm provides the Tokyo-based giant for now with “an incredibly elegant solution that has tremendous potential.”
BEIJING – China is aggressively pushing its goal to make drugs more affordable, and foreign pharma giants are adjusting their pricing strategy for a market that comprises nearly 20% of the world’s population and is expected to continue growing. To achieve its goals, China is using its huge population, which stands at 1.43 billion, as a bargaining chip to negotiate prices with pharmaceutical companies.
MALAYSIA – Asian countries, like India, have been struggling to find a middle ground to the effective pricing of drugs and medical devices over the past year and several are looking at health technology assessment (HTA) programs as a solution for this issue.
A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer.
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