In a three-way deal, Takeda will distribute Moderna's COVID-19 vaccine under a government-supported program in Japan. China's CStone Pharmaceuticals granted EQRx ex-China rights to two checkpoint inhibitors. Singapore halted use of flu shots from SK Bioscience and Sanofi after reports of post-vaccination deaths in South Korea. And more.
Takeda will help Moderna handle Japanese regulatory approvals for its COVID-19 vaccine, mRNA-1273. Once the shot is approved, Takeda will distribute 50 million doses under a three-way agreement with the Japanese government. The Japanese drugmaker also has a separate deal to develop, manufacture and sell Novavax’s NVX-CoV2373 in Japan.
Just after signing over China commercial rights to PD-L1 inhibitor sugemalimab to Pfizer, CStone Pharmaceuticals has out-licensed ex-China rights to that and an anti-PD-1 antibody CS1003 to Fierce 15 winner EQRx for $150 million upfront, with a potential $1.15 billion in follow-up milestone payments. CStone has four phase 3 sugemalimab trials in the works.
The number of reports of deaths after flu shot vaccination keeps rising in South Korea. Local health authorities have refuted a link between the vaccines and the deaths, but Singapore regulators took the precaution of halting use of two products—from SK Bioscience and Sanofi Pasteur—which are the only brands associated with the deaths in Korea that are also available in Singapore.
LianBio raised $310 million to help it bring drugs to China and other Asian countries. The company launched in August with rights to cardio-renal programs out of BridgeBio and MyoKardia. It also hopes to break into neurology, inflammatory diseases, ophthalmology and rare diseases.
Daiichi Sankyo and partner AstraZeneca won FDA priority review for Enhertu’s application in HER2-positive, metastatic gastric or gastroesophageal junction cancer, with a decision date set for the first quarter of 2021. The antibody-drug conjugate shrank tumors in 51% of third-line patients in a phase 2 trial, versus 14% for chemotherapy.
Amid geopolitical tensions and the pandemic, many countries have looked to “onshore” drug production. “I think there might be a slightly more local focus as we move forward, maybe just a little bit of a lengthening of some of those supply chains,” Fujifilm Diosynth Biotechnologies CEO Martin Meeson said in an interview with CNBC.
India’s Cadila Healthcare is seeking outside partners to help manufacture up to 70 million doses a year of its experimental COVID-19 vaccine on top of its own annual capacity of about 100 million doses, Bloomberg reported. The vaccine, which uses plasmid DNA, is in phase 2 trials and expects to start a pivotal study by December.
Shilpa Medicare failed to adequately address a complaint of improperly sealed injectable drugs coming out of its plant in Telanga, India, and it didn't notify the FDA within three days of receiving the complaint. Shilpa also received numerous consumer reports of foreign particles in its drugs but blamed end-user error without justification, according to an FDA warning letter.
Takeda has extended its collaboration with Seqster, which will provide its platform for combining and visualizing patient information gathered from electronic health records, genomic profiles and wearables. The deal will give Takeda “better access to real-world evidence, integrating real-time into our workflows generating powerful data and insights for research and patient services,” a Takeda exec said.
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