Although the novel coronavirus has not caused any drug shortages, health regulators around the globe are preparing for potential disruptions as the outbreak drags on. Meanwhile, AstraZeneca is also expecting the outbreak to hit its business in 2020 given its high exposure to the Chinese market. Akebia Therapeutics will use a priority review voucher to speed things up with the evaluation of Otsuka-partnered anemia drug vadadustat, a potential rival to FibroGen and AZ’s roxadustat. And more.
AstraZeneca’s China sales grew by 28% at constant currencies in the fourth quarter to $1.19 billion, which accounted for 19% of the drugmaker’s total quarterly haul. AZ’s been projecting a mid-teens growth rate for its China business in the midterm due to a value-based procurement program. But the ongoing coronavirus represents a more imminent threat.
As the COVID-19 outbreak continues in China, the FDA has halted all plant inspections there for now. While the drug and medical device supply chains have held so far, the agency’s keeping an eye out for potential disruptions to supply or shortages, FDA Commissioner Stephen Hahn said. EU Health Commissioner Stella Kyriakides said her group has a task force monitoring supplies, and no shortages have occurred. India’s government determined local drugmakers have about two months of API supply on hand.
Akebia Therapeutics will use a priority review voucher license Vifor Pharma has bought to shave four months off the FDA review of oral anemia drug vadadustat. Akebia is sharing U.S. rights to the drug with Otsuka. The pair is racing against FibroGen and AstraZeneca’s roxadustat in the novel HIF-PHI class, which is being billed as a more convenient and safer alternative to erythropoiesis-stimulating agents.
Pairing Astellas and Seattle Genetics’ Padcev with Merck’s Keytruda induced a response in 73.3% of previously untreated bladder cancer patients who’re ineligible for cisplatin chemo in a phase 1b/2 study. Patients went a median 12.3 months without tumor progression, the update showed. SVB Leerink’s Andrew Berens projected the durability could help Padcev achieve $5.8 billion in peak sales.
Audentes Therapeutics, which was just bought by Astellas, is pouring $109 million into building a 135,000-square-foot gene therapy manufacturing facility in Sanford, North Carolina. The first phase is expected to be operational by 2021. Eventually, the site will employ 200.
In an interview with the Japan Times, Takeda CEO Christophe Weber said the “world has to be more proactive than reactive” in its vaccine investment. The former GSK vaccines head plans to make Takeda’s vaccine franchise a core business group.
Everest Medicines has appointed Eli Lilly veteran Kerry Blanchard as its CEO, as the Shanghai-based company intends to submit its first new drug application this year. Blanchard was most previously Lilly’s senior vice president of China drug development before taking up the chief scientific officer job at fellow Chinese biotech Innovent Biologics.
Eisai’s H3 Biomedicine has poached Kura Oncology’s cofounder Antonio Gualberto to be its chief medical officer. At his job, Gualberto will oversee R&D efforts around three clinical cancer candidates. The biotech also has a deal with Bristol-Myers Squibb to leverage its RNA splicing tech.
Eisai is pulling obesity med Belviq off the U.S. market after the FDA warned of a possible link to increased cancer risks in patients with either a cardiovascular disease or multiple risk factors. The observation came from a long-term study originally meant to examine the drug’s CV safety profile.
Dr. Reddy’s said an eight-observation Form 483 the FDA issued last August for its formulations facility in Duvvada, India, has been granted voluntary action initiated by the agency. The designation means the FDA won’t take enforcement action because the plant meets at least “minimally acceptable state of compliance.”
Sun Pharma has launched its “Take on Acne” awareness campaign. The initiative is targeting young people ages 12 to 25 to dispel misconceptions about acne and help them take control of what’s often a stigmatizing condition.
A collaboration between the Indian government, the FDA and other U.S. enforcement agencies stopped 500 shipments of drugs from illegally entering the U.S. The operation uncovered about 50 different FDA-regulated products, including for cancer and HIV, as well as opioids.