Eisai's Alzheimer's disease readout for lecanemab faces a heavy discussion on safety. BeiGene's Brukinsa hands down an all-around win against AbbVie and Johnson & Johnson's Imbruvica in a head-to-head trial. After a delay, Shionogi has snagged the first approval for its oral COVID-19 drug, now called Xocova.
Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer's data reveal
Safety signals have clouded over Eisia’s full phase 3 data release for Alzheimer’s disease candidate lecanemab. In two previously reported death cases, brain hemorrhages were identified as the cause. But Eisai argued that the deaths cannot be attributed to lecanemab as both patients were already associated with “significant comorbidities and risk factors” such as the use of blood thinners.
BeiGene’s Brukinsa has handed AbbVie and Johnson & Johnson’s Imbruvica a comprehensive defeat. Compared with the first-generation BTK inhibitor, the BeiGene drug cut the risk of tumor progression or death by 35% and induced a higher tumor response rate while causing fewer side effects in patients with previously treated chronic lymphocytic leukemia, according to data to be presented at ASH 2022.
3. Shionogi's COVID-19 antiviral nabs Japanese approval to rival drugs from Pfizer, Merck
Just as Shionogi filed its COVID-19 vaccine for a Japanese approval, the company has won a local emergency approval for its oral antiviral Xocova, or ensitrelvir. The 3CL protease inhibitor clinched the go-ahead after a delay in July, when Japan’s drug regulator said it needed more data from a phase 2/3 study. Shionogi is also looking for a U.S. approval.
4. After FDA setback, MEI, Kyowa confirm phase 2 efficacy with Japanese blood cancer data drop
MEI Pharma and Kyowa Kirin’s zandelisib recently hit an FDA wall as the agency raised the bar on the entire PI3K inhibitor class because of safety concerns. But that didn’t stop the partners from pursuing approvals with midstage trials elsewhere. In a phase 2 trial in 61 Japanese patients with previously treated indolent non-Hodgkin lymphoma, 75.4% of participants had responded to the therapy.
5. Kyowa Kirin offloads mature drugs to Grünenthal amid 'challenging business environment'
As Kyowa Kirin focuses on innovative drugs like zandelisib, it’s slimming down in mature products. The Japanese company is separating its international established medicines portfolio—including 13 brands in the Europe, Middle East and Africa region—into a new joint venture with Germany’s Grünenthal. The latter will pay Kyowa Kirin about $85 million for a 51% stake with the intention to take full control in 2026.
China’s Fosun Pharma is reportedly considering pawning off Gland Pharma as the Fosun conglomerate plans $11 billion in asset sales in the next 12 months. But the Indian drugmaker said it was “not aware of any such information.” Instead, the injectable drugs maker inked a deal of its own, paying up to 120 million euros for European CDMO Cenexi Group.
7. Fosun unit Wanbang and Sirona Biochem pen new licensing pact for non-insulin diabetes candidate
Meanwhile, Fosun Pharma’s Wanbang Biopharmaceuticals is expanding a partnership with Canadian biotech Sirona Biochem. The deal centers on Sirona’s SGLT2 inhibitor TFC-039. Wanbang originally obtained Chinese rights to develop the drug as an animal treatment. But Sirona said it has started talks with a large pharma company to develop the med for human diabetes, so the Fosun deal now covers that as well.
Other News of Note
8. This Thanksgiving, FDA sanctions are bountiful for Lupin
9. On a roll, Takeda's dengue vaccine shifts into FDA's fast review lane
10. Fujifilm commits $188M for cell culture media capacity amid expansion spree
11. GSK to slash about 150 consumer commercial jobs in India
12. Busy WuXi Biologics debuts new manufacturing facilities at biologics center in Shanghai