Takeda’s growth driver Ninlaro hit a snag at the FDA as the agency asked for overall survival data before considering its application in the maintenance multiple myeloma setting. The Japanese pharma was also ordered to pay Bayer $155 million over patent infringement by a Shire hemophilia drug; Takeda closed its deal for Shire last month. Chinese investors, together with ARCH Venture Partners, backed a New York startup focused on preventing dormant tumor cells from spreading. And more.
Takeda has withdrawn an FDA application to expand Ninlaro’s use as a maintenance therapy in post-transplant multiple myeloma patients. It plans to refile once its overall survival data is ready. Ninlaro has been one of the growth drivers Takeda has been counting on. In the quarter that ended in December, Ninlaro sales rose 33.2%, to 17.1 billion yen ($157 million).
Early into its ownership of Shire, Takeda was hit by a patent infringement verdict that ordered it to pay Bayer $155 million. Bayer argued that Baxalta’s drug Adynovate infringed on its patent on recombinant Factor VIII technology for hemophilia, and the jury agreed on all four claims. Baxalta is a unit of Shire.
HiberCell, which focuses on preventing metastasis and relapse, was launched with $60.75 million from ARCH Venture Partners and Chinese investors Hillhouse Capital and 6 Dimensions Capital. With research from Mount Sinai, the company plans to combat dormant disseminated tumor cells by eradicating them or by inducing dormancy.
Dr. Reddy’s Laboratories, which last fall began a recall of three lots of infants’ ibuprofen, has now added three more lots to the effort. The product was produced by its Tris Pharma unit, whose plant in Monmouth Junction, New Jersey, was slapped last year with an FDA warning letter for its lack of urgency about investigating product failures.
China’s anticorruption authorities have punished 48 officials found responsible for the Changchun Changsheng Life Sciences vaccine scandal that provoked public outrage last summer. Among them, Wu Zhen, former deputy director of the old China FDA, was handed over to prosecutors over suspected duty-related crimes.
Indivior is out-licensing Chinese rights related to Suboxone to Zhejiang Pukang Biotechnology in a deal potentially worth $122.5 million. The transaction “is consistent with Indivior’s efforts to prioritize efforts on the long-term growth opportunities with our new depot assets, Sublocade and Perseris,” said Indivior CEO Shaun Thaxter.
After banning the imports of Hangzhou Guoguang Touring Commodity in October, the U.S. FDA has slapped its finished pharmaceutical plant with a warning letter. The FDA said inspectors found the facility with almost no controls on the over-the-counter products it was shipping to the U.S.