Daiichi Sankyo made changes to its top ranks as it accelerates development of new molecules through the pipeline. A Fosun Pharma subsidiary won a green light for its Rituxan copycat in China, and it's the country's first approved biosimilar. Nasdaq-listed Chinese vaccine maker Sinovac has activated a “poison pill” takeover defense against a group of shareholders that together own 40% of the company. And more.
Daiichi Sankyo is promoting Junichi Koga, Ph.D., to lead global R&D at the company’s U.S. site in New Jersey. Ken Keller, who’s been overseeing commercial operations, has been named as president and CEO of Daiichi’s U.S. division. Keller will “focus on forging even stronger collaboration between R&D and commercial efforts,” the company says. Both Koga’s and Keller’s new titles have been held by Glenn Gormley, M.D., Ph.D., who will become chairman of the U.S. affiliate.
Chinese authorities have approved the country’s first biosimilar, a copy of Roche’s Rituxan made by Fosun Pharma’s joint venture subsidiary Shanghai Henlius Biotech. Rituxan amassed about 1.73 billion yuan ($258.6 million) in China sales in 2017, according to Iqvia data cited by Fosun. The company is preparing to list the biologics unit on the Hong Kong Stock Exchange.
Sinovac is issuing new shares to dilute investor holdings so that some rebels can’t take control. It’s the first “poison pill” defense in more than a decade, Reuters reports. OrbiMed, 1Globe Capital, Chiangjia Li and others were identified as collaborators attempting a takeover. Together, those investors held 40% of Sinovac’s shares before the new issue.
FDA Commissioner Scott Gottlieb turned to Twitter to defend the quality of the U.S. generic drug supply, a large proportion of which comes from abroad. Gottlieb pointed out that FDA inspections of generic manufacturing facilities have increased, and the number of warning letters issued is up nearly fivefold. There were 24 warning letters sent to Chinese sites last year and 15 to sites in India.
After examining postmarketing data, the FDA decided Takeda’s gout drug Uloric carries an increased risk of death compared with the older drug allopurinol. The agency slapped a boxed warning on Uloric’s label and is limiting its use to the second-line setting—patients who have failed on or do not tolerate allopurinol.
Abpro is partnering with China’s NJCTTQ to develop new bispecific antibodies against unspecified targets. Abpro could collect up to $4 billion, which includes $60 million in near-term R&D funding. NJCTTQ could get Chinese rights for drugs that come out of the collaboration. Abpro in 2016 signed a $3.5 million deal with Chinese biotech Essex Bio to co-develop monoclonal antibodies.
Takeda doubled down on rare diseases with its Shire deal, and now it's teaming up with Microsoft and Eurodis to speed up rare disease diagnoses. The partners devised three pathways to making that happen: The first program uses machine learning to identify symptom patterns, the second focuses on “intelligent triage” and genetic consultations, and the third project is working to develop a secure rare disease patient registry.
Shortly after Dr. Reddy’s reported that the FDA had issued a Form 483 for its formulations plant in Bachupally, India, the FDA posted another Form 483 for the Indian firm’s solid dose plant in Pradesh. Four violations were cited, including failure to investigate out-of-spec analysis when impurities were found.
The FDA had found problems at an Aurobindo sterile manufacturing plant last year, and another inspection recently revealed some similar problems. In a 12-page Form 483 for the Unit IV facility in Pashamylaram, India, the agency again described some sanitation shortfalls. The plant has several pending drug applications before the FDA.
Thermo Fisher Scientific has halted sales of its DNA sequencing hardware in western China, following a series of reports that its products were being used in a state surveillance program aimed at ethnic minorities in the region, according to The Wall Street Journal.
PPD has inked a deal with China’s Happy Life Tech (HLT) to develop data science-driven drug R&D solutions for both global and Chinese biopharma companies. HLT will offer its AI and data tech and PPD its expertise in clinical trial management and evidence generation.