South Korea’s securities regulators said Samsung BioLogics intentionally violated accounting rules and they suspended trading of its stock. Merck & Co. will provide $1.2 billion worth of Gardasil vaccines to China in 2020. Chinese authorities proposed new draft regulation to crack down on future illegal vaccine practices. And more.
Ruling that Samsung BioLogics intentionally violated accounting rules before going public in 2016, South Korea’s stock regulators have suspended trading of the company and a review is underway for potential permanent delisting. The watchdog also recommended dismissal of the company's CEO and sent the case to prosecutors. The whole crisis stemmed from how the contract biologics manufacturer changed its accounting method tied to its Biogen-partnered biosimilar business, Samsung Bioepis.
Through a renewed contract with a local distributor, Merck & Co. has promised to supply 8.33 billion yuan ($1.20 billion) worth of Gardasil products in China in 2020, significantly more than the amount planned back when Gardasil 9 was not yet approved in the country. However, a company representative said even as the company works to triple global supply, it won’t be able to meet the full demand in China.
China’s market regulators have proposed a draft regulation designed specifically for vaccines. Based on the seriousness of the offense, the penalty could reach 10 times the involved products’ market value. The draft came shortly after Chinese regulators fined Changchun Changsheng Life Sciences $1.3 billion for faking data to cover up illegal manufacturing practices.
Korean regulators are probing a local wholesaler for allegedly smuggling Novo Norisk’s anti-obesity drug Saxenda into China, where it’s not yet approved. Novo confirmed that its Korean distributor, Zuellig Pharma, has terminated the contract with the wholesaler. The drug, alongside Novo’s overall GLP-1 franchise, has been posting fast growth recently.
Dr. Reddy’s acknowledged two weeks ago that its oncology drug plant in Visakhapatnam, India, was cited by the FDA. According to the Form 483, five of the eight observations were repeats of earlier citations. Inspectors found issues with a filling line that resulted in vials of cancer drug docetaxel with loose or missing seals, leaving vials exposed to potential contamination.
Mitsubishi Tanabe, maker of ALS drug Radicava, launched ALSO US, an online program asking young people who have a family member with ALS to submit original artwork, videos or stories. As of September, Radicava was being used to treat about 3,190 people in the U.S.