Novartis is refocusing its Shanghai R&D operation to drug development instead of early drug discovery. BeiGene nabbed the first FDA nod for a China-discovered cancer drug, a challenger to Johnson & Johnson and AbbVie's Imbruvica and AstraZeneca's Calquence. The FDA approved Shionogi's antibiotic Fetroja for certain urinary tract infections but included a serious warning on mortality. And more.
Novartis is changing the focus of its Shanghai R&D institute, known as CNIBR, from early drug discovery to drug development. Some 150 employees who work in early research will leave, as the company plans to add 340 development and commercial jobs by 2023. The pivot is the result of Novartis’ “need to better resource early drug development globally, combined with important changes to the drug development and commercialization landscape in China,” Novartis Institutes for Biomedical Research chief Jay Bradner told FierceBiotech.
BeiGene has nabbed the first FDA green light for a cancer drug discovered in China. Brukinsa, or zanubrutinib, is a new BTK inhibitor that will be squaring off against AbbVie and J&J’s blockbuster Imbruvica and AstraZeneca’s Calquence. While the initial nod is in mantle cell lymphoma, the Chinese biotech is also running phase 3 head-to-head trials against Imbruvica in Waldenstrom’s granuloma and the much larger indication of chronic lymphocytic leukemia.
Shionogi’s antibiotic Fetroja has won FDA approval to treat patients with complicated urinary tract infections caused by gram-negative microorganisms. Phase 3 data showed the drug eliminated bacteria and resolved symptoms in 72.6% of patients after seven days, versus 54.6% for another antibiotic. However, Fetroja comes with a serious warning label after trial data showed a higher rate of death.
Brii Biosciences has struck a series of deals for greater China rights to antibiotics. It’s in-licensing a tuberculosis drug from AN2 Therapeutics, some treatments from Qpex Biopharma that are aimed at drug-resistant bacteria, and several candidates from Artizan Biosciences. While multidrug resistance has yet to spur a big push for new antibiotics in the U.S., “the threat level is high enough [in China] to make the commercial case,” Brii CEO Zhi Hong said.
In August, Torrent Pharma recalled dozens of lots of over-the-counter cough syrups, nasal sprays and rectal suppositories due to risk of bacterial infection. In a warning letter, the FDA said the water system at the company’s plant in Levittown, Pennsylvania tested positive for bacteria.
The FDA has slapped a warning letter on Greenbrier International, owner of the nearly 16,000 Dollar Tree and Family Dollar stores. The FDA found the company had used Chinese contract manufacturers and suppliers who had been banned from the U.S. to make Dollar Tree’s Assured Brand drugs. Even after the FDA notified the company of the problem, some products still made to the shelves.
Eisai has launched Ella the Jellyfish on Amazon Alexa. The new skill can sing, play games, tell stories and offer guided meditations, and is designed just for children with Lennox-Gastaut syndrome, a rare epilepsy. The Japanese drugmaker makes antiepileptic med Fycompa, which is currently in a phase 3 clinical study for patients with seizures associated with LGS.