Several partnerships have been formed to develop therapies against the novel coronavirus, including ones between Harvard University and Guangzhou Institute of Respiratory Health, GlaxoSmithKline and Clover Biopharmaceuticals, and Vir Biotechnology and WuXi Biologics. Takeda has exercised its option to acquire PvP Biologics for its celiac disease candidate. And more.
Harvard University and China’s Guangzhou Institute of Respiratory Health have entered into a five-year research collaboration focused on understanding the novel coronavirus and finding new therapies against it. The U.S. efforts will be led by Harvard Medical School Dean George Daley, and the Chinese part will be co-led by Zhong Nanshan, who heads up China’s coronavirus expert task force. The pair’s getting $115 million in funding from Evergrande Group, a top China real estate developer.
In another COVID-19 team-up, GlaxoSmithKline has agreed to provide its adjuvant AS03 to China’s Clover Biopharmaceuticals for developing a vaccine against the coronavirus. The adjuvant was used in GSK’s Pandemrix vaccine to protect people during the 2009-10 H1N1 pandemic. Clover is looking to leverage the tech’s immune-boosting effect in its vaccines.
Meanwhile, Vir Biotechnology has chosen WuXi Biologics to be its partner for work on antibodies as potential treatment of COVID-19. The U.S. biotech has already identified several antibodies that bind to SARS-CoV-2 and may use its platform to identify more, while the Chinese CDMO will mainly contribute manufacturing support. WuXi has rights to successful therapies in greater China.
In early 2017, Takeda signed on PvP Biologics for the development of KumaMax, a novel enzyme designed to fight celiac disease, an autoimmune disorder triggered by gluten ingestion. Now, after seeing phase 1 data for the drug, also dubbed TAK-062, the Japanese pharma has exercised its option to buy up the company in a deal valued at $330 million.
As COVID-19 hits China, South Korea and Japan, Gilead Sciences has initiated two new phase 3 clinical studies testing its antiviral remdesivir. Investigators plan to enroll about 1,000 patients, mainly in Asian countries. The drug’s already being studied in two trials in China’s Hubei province and another in the U.S., led by the National Institute of Allergy and Infectious Diseases.
Biocon said it had received a Form 483 from the FDA for its insulin production plant in Malaysia. Though the preapproval inspection resulted in three observations, Biocon said those wouldn't affect the commercial plans for its Lantus copy, Semglee, in the U.S. The biosim has won approval in Europe, and the FDA decision date is set for June.
AstraZeneca recently closed two plants in Colorado it originally bought from Amgen. The Longmont plant was sold to Novartis’ AveXis, and now the remaining Boulder plant is reportedly being sized up by Japanese CDMO AGC Biologics. Local development officials have offered $6.5 million in tax incentives, and the CDMO will invest about $100 million in the facility and add 280 jobs.
Fujifilm Diosynth Biotechnologies last year committed JPY10 billion toward its manufacturing operations. Now, to kick things off, a $55 million, 32,000-square-foot expansion is underway at its manufacturing facility in North Carolina.
Takeda U.K. has launched the “I am Number 17” rare disease awareness campaign, which features 17 rare disease patients and is designed to highlight the fact that 1 in 17 people in the country will be affected with a rare disease at some point in their lives.
The FDA has sent Chinese heparin API maker Yibin Lihao Bio-technical a warning letter. During a preapproval inspection, the company lied to an FDA inspector that it had not started making products. But a drum an employee was trying to sneak out of the warehouse contained two batches of crude heparin made two days earlier.