Takeda's dengue shot has won its first approval anywhere. Eisai has debuted its new U.S. headquarters with about 800 employees. In relief for several New York-listed Chinese biotechs, U.S. and Chinese authorities have reached a deal that would allow American accounting watchdogs access to Chinese companies’ audit records.
1. Takeda's dengue fever vaccine picks up first global nod in Indonesia
Takeda’s dengue fever vaccine has received its first approval. Indonesian regulators have cleared it in people 6 to 45 years of age regardless of prior dengue exposure. The vaccine, called Qdenga, fills a void left by Sanofi’s Dengvaxia. Years back, that shot was found to worsen cases in people who hadn't had prior exposure. Clinical data so far suggest the Takeda shot doesn’t have the same problem.
2. Eisai inaugurates new US HQ as closely watched FDA Alzheimer's decision draws near
Eisai has officially launched its new U.S. headquarters, located on the ON3 Campus in Nutley, New Jersey, an old Roche site. About 800 employees are based out of the new 332,800-square-foot facility, which can hold up to 1,300 people. When Eisai announced the move two years ago, it said the plan was to transfer up to 1,200 U.S. corporate and R&D functions to the new location.
3. US, China sign audit inspection deal that could mitigate NY-listed biotechs’ delisting risk (Reuters)
U.S. and China have signed (Chinese) an agreement that is set to allow American accounting watchdogs access to Chinese companies’ audit records. Amid a recent U.S. Securities and Exchange Commission (SEC) crackdown, several biotechs with Chinese roots, including BeiGene, Zai Lab, Hutchmed and I-Mab, were put on a watchlist and faced delisting.
The agreement doesn’t automatically mean the delisting threats for those companies are gone. Rather, it is “merely a step in the process,” SEC Chair Gary Gensler said in a Friday statement. “This agreement will be meaningful only if the [Public Company Accounting Oversight Board] actually can inspect and investigate completely audit firms in China.”
4. Pfizer taps company coming off FDA ban for Paxlovid production in China
Pfizer has tapped Zhejiang Huahai Pharmaceutical to help make COVID-19 drug Paxlovid for the Chinese market for five years. Pfizer will provide the two active ingredients, nirmatrelvir and ritonavir, and Huahai will make the final product. Huahai is one of China’s largest drug ingredient manufacturers, but possible carcinogens found in its blood pressure meds triggered a global recall of “sartan” products starting in 2018.
BeiGene has tapped McKesson’s real-world evidence business Ontada for cancer awareness campaigns in the U.S. The goal is to “improve community education on the financial impact and value of cancer drugs” and to “improve patient access to oncology medicines,” BeiGene said. BeiGene is nearing an FDA decision for Novartis-partnered PD-1 inhibitor tislelizumab.
6. China suspends UCB's anti-seizure drug Keppra after inspectors flag manufacturing issue
Chinese drug regulators have suspended the import, sale and use of UCB’s anti-seizure drug levetiracetam following a virtual inspection of the company’s Belgium facility. The problem was inconsistency between the displayed expiration period of some batches and that of registration.