As Gilead Sciences' investigational remdesivir emerged as a promising drug against the new coronavirus, a Chinese research institute has applied to patent that use. Gilead's CEO Daniel O'Day said the company doesn't plan to get into a dispute. Takeda is looking to sell a Shire biologics plant, which currently has 200 employees. Glenmark spinoff Ichnos Sciences has tapped Gabriela Gruia, most recently head of regulatory affairs for Novartis Oncology, as its chief development officer. And more.
China has officially begun enrolling patients in double-blinded clinical trials of Gilead’s remdesivir as a treatment for the new coronavirus. The decision came after the experimental drug showed promise in a U.S. patient and in cells grown in the lab.
Meanwhile, the Chinese Academy of Sciences’ Wuhan Institute of Virology said it has applied for a patent in China for remdesivir’s use in 2019-nCoV “from the perspective of protecting national interests.” Commenting on the case at an internal company event, Gilead CEO Daniel O’Day said the drugmaker “will not get into a patent dispute,” stressing that its “responsibility is the patients.”
Follow our regularly updated Coronavirus tracker.
Shire had big plans when it built a $400 million biologics plant in Ireland. But after Takeda bought the company, the combined drugmaker found it has excess capacity. Takeda has decided to sell the Dunboyne facility, which currently has 200 employees. Given the capabilities of the plant and its 200 employee-strong workforce, Takeda said it could be “an attractive asset.”
After Glenmark raised the curtain on its biotech spinoff Ichnos Sciences, with former Gilead and Novartis executive Alessandro Riva at the top, the new U.S.-headquartered company has hired another ex-Novartis exec. Gabriela Gruia, M.D., who oversaw regulatory affairs for Novartis’ oncology team, is Ichnos’ new chief development officer.
Thanks to faster integration with Shire, Takeda’s now looking to report operating profit of 10 billion yen ($92 million) for the fiscal year ending in March, versus a previous forecast of a loss. But after recent discussions with the FDA, the Japanese pharma doesn’t expect to resume normal supply of Natpara in the U.S. before March 2021.
Sanofi’s China sales suffered in the fourth quarter due to the implementation of a volume-based procurement program for older medicines. During the three months, its China sales dropped 21%, and Sanofi expects Plavix and Aprovel numbers to fall by 50% in 2020.
China is a major supplier of drug ingredients to the U.S., so as the country works to combat the new coronavirus, worries of this reliance have popped up again. China’s huge population means it might struggle to meet domestic demand amid an epidemic, let alone sending medicines to the rest of the world. There’s also the concern that the spread of the virus may hurt manufacturing capabilities.
The FDA has issued a Form 483 to Lupin’s API plant in Andhra Pradesh following an inspection that ended Jan. 17. Five observations were cited, including failure to identify the critical process parameters for APIs and intermediates. Some materials from suppliers were not tested for identity and purity.
Just months after collecting $90 million to support the launch of its compact DNA sequencing hardware, GenapSys has raised another $75 million. This time, it’s pushing its sequencer in South Korea, Singapore, Japan and China. The company has also been approached by China’s CDC to help understand the genetic features of the new coronavirus.
Verily is planning to form a joint venture with Osaka-based Santen Pharmaceutical. The new entity will apply “microelectronics and scalable digital technologies” to build “unique ophthalmic devices.” It will involve machine learning and artificial intelligence as well as connected and integrated medical devices.
Novo Nordisk and Lonza have both extended the Chinese New Year holiday for their employees in China amid the ongoing coronavirus outbreak. Novo CEO Lars Fruergaard Jørgensen said the measure could lead to slower growth of new drugs in the short term. Lonza has halted operations at plants in Nansha, Suzhou and Guangzhou.
San Diego’s Eurofins Discovery and Shanghai-based PharmaResources are joining forces to try to help life science clients increase the efficiency of their drug discovery timelines. They have penned a commercial cooperation in which the Chinese CRO’s customers can gain access to Eurofins’ portfolio.