Takeda's dengue vaccine is getting closer to challenging Sanofi's Dengvaxia as the Japanese drugmaker announced the shot met its goals in a large phase 3 trial. Pfizer introduced an alternative payment scheme to China's oncology market with a pay-for-performance deal on Ibrance. Aslan plans steep job cuts after its lead candidate failed in gastric cancer. And more.
Takeda said its dengue vaccine candidate, TAK-003, met its efficacy endpoint in a 20,000-participant phase 3 study. If approved, the vaccine could challenge Sanofi’s Dengvaxia, which caused controversy when the company announced safety risks for dengue-naïve people. Takeda is working on commercial production and other preparations for a potential launch.
Pfizer launched China’s first pay-for-performance program in oncology, featuring its blockbuster breast cancer drug Ibrance. It’s a small program that will accept no more than 500 patients. Pfizer promises reimbursement of up to 33.5% of Ibrance costs if an enrolled patient’s disease progresses within four months.
After its lead candidate varlitinib failed a key gastric cancer trial, Singapore-based Aslan Pharmaceuticals has decided to cut its headcount by 30%, hoping to halve its operational costs and focus its resources on advancing the drug in biliary tract cancer. Its chief medical officer, Bertil Lindmark, M.D., Ph.D., will also retire.
Samsung BioLogics’ sales for 2018 reached KRW 535.8 billion ($482 million), up 15.3%, as it continues expanding its capacity with new facilities. While its operating profit dropped, its net profit increased by KRW321.1 billion thanks to Biogen’s purchase of an additional stake in their biosimilars joint venture, which got the Korean CDMO into accounting trouble with authorities.
FDA Commissioner Scott Gottlieb, M.D., said agency inspections of generic drug plants will increase through 2019. But an investigation by Bloomberg found that inspections in China last year were down by more than 10%—even amid the valsartan fallout. The report says a 2017 inspection of API maker Zhejiang Huahai Pharmaceutical found issues with drug quality tests, but some top FDA officials decided against a warning letter.
Lupin said the FDA has cited a plant in Indore, India, with six observations. No details were provided, but the plant was one the agency had previously criticized in a 2017 warning letter. In that letter, the FDA raised problems about the way Lupin employees handled out-of-spec testing results.
Hitachi Chemical Advanced Therapeutics Solutions is paying €75.5 million ($86.8 million) for Apceth Biopharma, a contract manufacturer of cell and gene therapy products. The deal gives the Japanese firm two manufacturing facilities in Munich. Hitachi also just opened a plant in Yokohama, Japan, and construction is underway for a third U.S. facility.
Ekso Bionics launched a joint venture in China with two local partners to build a dedicated manufacturing center for rehabilitation and industrial-use exoskeleton markets in Asia. Ekso will license its technology to the venture in exchange for a 20% ownership stake.
The European Medicines Agency found a risk of cross-contamination of products at a Micro Labs plant in Hosur, India. While the agency only cited one violation, regulators yanked the plant’s GMP certificate, suggested that countries recall its products and banned the entry of any new ones.