Bristol-Myers Squibb is pricing Opdivo in China at half of its U.S. cost, a strategy that would set a bar for other immuno-oncology therapies on their way to the key market. Novartis is bringing on its Malaysian head to lead its Korean unit, as its current acting CEO brought in amid a kickback scandal in 2016 is set to retire. GlaxoSmithKline's Indian consumer business has attracted more potential buyers in Kellogg and Reckitt. And more.
Opdivo’s price in China was finally made known: The drug will come in at about $1,354 for the large 100mg vial, while it costs around $2,600 to $2,800 in the U.S. The Chinese price is also a huge discount compared with other parts of Asia but could still be too pricey for patients. The expert who led Opdivo’s Chinese-specific phase 3 trial said he doesn’t expect Opdivo will be considered for national coverage.
In 2016, Novartis parachuted Klaus Ribbe from its headquarter into Korea to manage a doctor kickback scandal. Now a new country president will take his place. Joshi Venugopal, who most recently headed up Novartis Malaysia and Brunei, will take over the job of sorting out an ongoing lawsuit against the Korean unit, as Ribbe will retire at the end of September.
Kellogg and Reckitt Benckiser have reportedly joined a long list of companies eyeing GlaxoSmithKline’s Indian consumer health unit, according to The Economic Times. Reckitt has previously chased Pfizer’s consumer health unit but pulled out because it was too expensive. GSK’s Indian consumer business, according to analysts, could be worth $4 billion.
Eisai and Merck’s Lenvima just won an FDA nod in first-line hepatocellular carcinoma, the most common type of liver cancer, after a three-month delay by the agency. The approval sets Lenvima up to build on its $106 million sales in last quarter and challenge Bayer’s Nexavar.
As the fight against Johnson & Johnson’s Zytiga and Erleada intensifies, Pfizer and Astellas are speeding up two trials in patients with hormone-sensitive prostate cancer. A phase 3 that tests Xtandi in metastatic HSPC patients will end at the end of the year, instead the previously planned April 2020. Another study that tests it in men with high-risk nonmetastatic HSPC will finish in mid-2020.
Korean biotech ViroMed joined forces with a private equity firm to acquire a GMP-ready facility in San Diego from Vical. The facility has a 500 L fermenter, cell culture lab and quality control test lab, as well as space for expansion. The firm said the move will serve its goal to gain approval in the U.S. for its plasmid DNA-based gene medicines.
Harbour BioMed licensed a PD-L1 antibody from Kelun Biotech for rights outside of Greater China. Kelun stands to earn up to $350 million. The drug, A167, is currently in phase 1 and phase 2 trials in China for lymphoma and solid tumors. The PD-1/L1 field is already crowded, with five drugs already on the market, and several more in development.
A consortium of investors led by China Biologic Products’ former CEO has offered $118 a share to take the Nasdaq-listed firm private, in a deal that would value the plasma producer at $3.9 billion. Because China poses strict rules for importing blood products, the company could see big upside.
In a recent FDA warning letter, Kyowa Hakko Kirin’s API manufacturing branch admitted that its workers manipulated data to get passing results. The firm acknowledged the plant had an “environment where test data could be easily manipulated.” The agency also noted repeated issues it had found before.
Managers at Juxin Biotech in Lianyungang, China, will be criminally prosecuted after an explosion in December 2017 killed 10 and injured another. An investigation found the explosion was triggered by an equipment failure, and that the blast resulted in a direct economic loss of $7 million.
After putting Yicheng Goto Pharmaceuticals on its import alert list in January, the FDA has issued the Chinese API maker a warning letter. The agency said the firm was not properly testing for API stability and could not show its products met predetermined quality standards.
WuXi AppTec’s research service division and Canadian biotech Cyclica have teamed up on the development of small molecule polypharmacology. The multiphase collaboration is also designed to help drive Cyclica’s biophysics and AI-supported platform, the two said.