Eisai has decided to exit its supporting role for Biogen's Alzheimer's drug Aduhelm. Chinese companies including several biotechs face potential U.S. delisting if they fail to comply with a new audit law. Zai Lab has found a new chief operating officer in Eli Lilly's former chief financial officer, who's leaving after a scandal. And more.
1. Biogen takes full control of troubled Aduhelm in revamped Eisai deal
In a revised deal, Eisai shed its responsibilities for Aduhelm, giving partner Biogen full control over the controversial Alzheimer’s disease drug. Instead of sharing profits, the Japanese pharma will receive a tiered royalty starting next year. The revamp comes as a draft reimbursement policy for Medicare threatens Aduhelm’s commercial prospects.
BeiGene, Hutchmed and Zai Lab have joined a list of five companies that failed to follow the U.S. Securities and Exchange Commission's new audit rules. The firms face potential delisting if they don’t comply for three consecutive years. The problem stemmed from a conflict between U.S. and Chinese laws. The Chinese government has signaled a possible solution, stating that regulators from both countries are progressing toward a cooperation plan.
3. Zai Lab hires ex-Lilly CFO who departed after investigation found 'inappropriate' behavior
Zai Lab enlisted Josh Smiley as its new chief operating officer. The former Eli Lilly chief financial officer left the Indianapolis pharma after an external investigation found “consensual but inappropriate personal communications” with multiple employees.
4. Astellas' menopause drug suffers rare setback as failed Asian trial blots previously pristine record
After passing two phase 3 tests, Astellas' menopause drug, fezolinetant, failed in a late-stage trial of patients in Asia. After 12 weeks, Astellas saw numerical improvements in the rate of hot flashes from baseline for fezolinetant, but the difference from placebo didn’t meet statistical significance.
5. After Alexion buyout, AstraZeneca pays Roche $775M to settle Ultomiris patent brawl
AstraZeneca’s Alexion will pay $775 million to Roche’s Chugai Pharmaceutical to resolve all patent disputes related to the former's C5 inhibitor Ultomiris. In lawsuits filed in the U.S. and Tokyo, Chugai accused the AZ rare disease unit of infringing its patents relating to the time an antibody drug can remain active in the body.
6. Shionogi's COVID-19 antiviral heads to phase 3 backed by NIH after receiving FDA go-ahead
Shionogi’s oral COVID drug, dubbed S-217622, is moving into a phase 3 trial as part of the National Institutes of Health’s basket ACTIV-2 study. The trial will recruit about 1,700 people across the globe to test the therapy in high-risk, non-hospitalized adults. The drug has a mixed bag of results in midstage testing.
7. Stevanato's growth spree rolls on with China plant purchase, plans for 270 jobs
Italy’s Stevanato Group has acquired a plant in Zhangjiagang, China, to make EZ-fill syringes and vials. Stevanato will renovate the new site, adding 7,000 square feet for a total of 32,000. The company plans to employ 270 there and double its current production capacity by 2024.
8. Indian pharma, US plastic surgeon reach deal to build $50M drug plant in Africa
Indian company Sushen Medicamentos and U.S. physician and philanthropist Michael Obeng, M.D., will invest $50 million to build a drug manufacturing facility in Ghana. With construction expected to be done by June 2023, the facility will make medications for high blood pressure, diabetes, malaria and pain.
India’s Macleods Pharmaceuticals has issued a nationwide recall for 3,672 bottles of blood pressure drugs amlodipine and olmesartan medoxomil plus schizophrenia treatment olanzapine. The recalls cited manufacturing “deviations” as the cause of the action.