In another episode of Pfizer's legacy Hospira manufacturing problem, an Irungattukottai, India, plant was once again cited by the FDA, leading it to suspend production. China and India are working on measures to grant Indian drugs greater access to China's pharma market. Roivant Sciences just unveiled its China-focused member, Sinovant, which has 11 assets in development.
The FDA slapped a 32-page Form 483 on Pfizer’s Irungattukottai, India, plant that was bought with Hospira. The injectables plant has twice before been cited for manufacturing and testing problems. This time, the FDA outlined 11 observations, including that workers “manipulated test sample weights to obtain passing results” for batches of raw materials and finished product.
China and India are cozying up on drug imports as both are fighting the U.S over tariffs. China is working to grant greater access to Indian drugs, according to a China Foreign Ministry spokeswoman. These measures could include an expedited review pathway, Reuters reported. China has also set up training programs to help Indian pharmas understand China’s regulatory system.
Vivek Ramaswamy's Roivant Sciences just made public another member of the “vant” family. Dubbed Sinovant, the Shanghai-based company is focused on bringing innovative medicines to China and advancing Chinese innovation abroad. Founded in 2017, it already has 11 assets in development, with four poised for phase 3.
Pfizer and Astellas’ Xtandi, already approved for metastatic prostate cancer, has won an FDA green light to treat nonmetastatic patients, “a significant expansion” the partners have been counting on. The drug delivered a combined $2.59 billion for the two companies last year, but growth had started lagging, with Johnson & Johnson’s rival drug Erleada fighting for market share.
Takeda CEO Christophe Weber recently said China could be its second-biggest business in the long term. But that won’t be an easy task. Based on fiscal year 2017’s numbers, Japan, currently second on Takeda’s sales rankings, is worth 10 times as much as China. Adding Shire will also be a mixed opportunity. Shire only sells three drugs in China now, but the country is accelerating orphan drug approvals.
Chinese biotech Ascentage just raised $150 million in a series C round to help advance 16 ongoing clinical trials, build out R&D and manufacturing facilities and hire around 60 new employees. The seven drug candidates in its portfolio are designed to induce programmed cell death in cancer, targeting novel pathways BCL-2, MDM2-p53 and IAP.
The FDA has sought voluntary actions to take some heart drugs made of valsartan supplied by Zhejiang Huahai Pharmaceutical off U.S. shelves due to a potential cancer-causing residue, following a similar move by the EMA. The recall in the U.S. includes products sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare.
Changchun Changsheng Life Sciences’ manufacturing license tied to its Vero cell-based rabies vaccines was revoked by China’s drug regulator right after inspectors found that the firm forged production records. Based on 2017 numbers, the company is China’s second-largest rabies vaccines supplier. The latest action reflects China’s hardball policy over vaccine safety.
A year after Takeda tied up with Ovid Therapeutics to advance its epilepsy drug TAK-935, a selective inhibitor of CH24H, the pair announced two phase 2 trials in rare pediatric epilepsies and an extension trial for patients with developmental and epileptic encephalopathies.
In a 12,000-patient cardiovascular outcomes study, Eisai’s obesity drug Belviq showed it is heart-safe, making it the first chronic weight management drug to show such a benefit. But it remains to be seen whether that claim can boost sales, as obesity drugs have failed to gain traction in years.
After establishing a foothold in Europe by snatching up Bristol-Myers Squibb’s API plant in Ireland, South Korea’s SK Holdings has made a deal to buy AMPAC, a U.S. CDMO that makes APIs for controlled substances.