Moderna is considering building a manufacturing plant in Japan, its CEO says. Takeda has offloaded an unwanted cancer drug to Puma Biotechnology. Everest Medicines has hired former Gilead China head as its new CEO. And more.
1. Moderna CEO wants to build plant in Japan pending a long-term vaccine deal: report
Moderna would build a vaccine manufacturing facility in Japan if it can secure a long-term vaccine deal with the government, CEO Stéphane Bancel told Nikkei during a vaccine diplomacy trip to the country. Japan this week approved Moderna and Pfizer-BioNTech bivalent boosters against the omicron BA.1 subvariant, and, now, Moderna is preparing to apply for a new booster targeting the BA.5 subvariant.
2. Puma pounces on failed Takeda drug, snapping up cancer prospect for knockdown price
Puma Biotechnology has decided to resurrect a Takeda castoff. For an aurora kinase inhibitor called alisertib, Puma is paying Takeda $7 million upfront and up to $287.3 million in milestones. The drug failed a phase 3 trial in peripheral T-cell lymphoma in 2015, and Takeda has ceased internal development after a phase 2 small cell lung cancer trial ended. Puma is now eyeing the drug to treat breast cancer and small cell lung cancer.
3. Everest appoints Gilead, COVID therapy vet CEO to bring therapies to market in China
Everest Medicines has named former Brii Biosciences’ president and general manager for greater China Rogers Yongqing Luo as its new CEO, replacing Kerry Blanchard. Luo is best known as the former head of Gilead Sciences in China, building up that operation from scratch and overseeing eight launches.
4. FDA advisory committee votes down Spectrum’s lung cancer hopeful in wake of efficacy concerns
Spectrum Pharmaceuticals and Hanmi Pharma’s Pozenveo, or poziotinib, got a thumbs-down from an FDA advisory committee for previously treated non-small cell lung cancer with EGFR exon 20 insertion mutations. The 9-4 vote against an accelerated approval comes after the FDA raised concerns regarding the drug’s dosing and efficacy, especially in light of a recent approval for AstraZeneca and Daiichi Sankyo’s Enhertu.
5. Clover touts phase 3 omicron data as wait for COVID-19 vaccine approvals drags on
China’s Clover Biopharmaceuticals, late to the COVID-19 vaccine scene, is touting its first-generation adjuvanted protein vaccine as a “universal booster.” Latest data from a phase 3 trial showed its shot, SCB-2019, induced fivefold higher neutralizing antibodies against the BA.5 subvariant when given to people who previously received an inactivated vaccine.
6. BeiGene keeps its Brukinsa momentum going by winning NICE nod for rare lymphoma
England’s drug cost watchdog has blessed BeiGene’s BTK inhibitor Brukinsa as a second-line treatment for Waldenstrom macroglobulinemia. This decision makes Brukinsa the only treatment for the disease allowed for routine use in England and Wales.