Welcome to this week’s FiercePharmaAsia report, which includes stories about China’s National Reimbursement Drug List update after eight years, Daiichi Sankyo and ArQule’s tivantinib failing a phase 3 liver cancer test, an FDA Form 483 sent to Dr. Reddy’s, and more.
1. China updates national drug list, adding some blockbuster Western meds
It’s been about eight years since China last updated its National Reimbursement Drug List, which states all drugs covered by the country’s medical insurance programs. Among those newly added to the list are blockbuster meds like GlaxoSmithKline’s antiviral med Viread and AstraZeneca’s cancer drug Iressa, both of which underwent more than 50% price cut before the inclusion.
2. Daiichi, ArQule’s struggling tivantinib fails in phase 3 liver cancer test
Daiichi Sankyo and ArQule’s MET-inhibitor tivantinib continued to fail in clinical, most recently in a 340-patient phase 3 trial for liver cancer. The drug didn’t beat placebo for the trial’s primary endpoint—improving overall survival. The strings of setbacks aroused wide suspicions on the drug’s future.
3. Dr. Reddy's API plant stays on probation with an FDA Form 483
Dr. Reddy’s has already been struggling with an FDA warning letter that lambasted three of its India plants for data integrity, a regulatory roadblock that delayed the Indian drugmaker’s intended launch of a generic of cancer drug Gleevec. Now, it needs to deal with a Form 483 issued for one of those facilities.
4. Takeda, TiGenix stem cell therapy shows sustained effect
After posting positive 24-week data from a phase 3 trial for Cx601 stem cells in 2015, TiGenix and partner Takeda presented encouraging 52-week data on their allogeneic expanded adipose-derived stem cells in Crohn’s disease patients with treatment-refractory complex perianal fistulas.
5. Sun moves forward with plant in Egypt started by Ranbaxy
Sun Pharma’s Ranbaxy unit has started work on a $12.5 million manufacturing plant near Egypt’s capitol, Cairo, a project that got under way well before Sun bought Ranbaxy in 2015. The country project was delayed by Egypt’s political turmoil.
6. Takeda to trial depression-monitoring Apple Watch app
Takeda has teamed up with Cognition Kit to trial the use of an Apple Watch app the latter developed to monitor people with depression. The project will assess the feasibility and effectiveness of using wearable devices to track the mood and cognition of people with the condition.
7. India's Granules to build new API plant in Vizag as part of $84M expansion
The International Finance Corp will invest $47.5 million in Granules’ $84 million API bulk drug project in India. The project includes a new API plant at the Vizag site, as well as intermediates capacity expansion and improvements to Granules’ R&D operations to allow it to produce higher-value products.
8. FDA slaps Chinese manufacturer in warning letter for obstructing inspection
Zhejiang Bangli Medical Products, a medical dressing manufacturer in china, was slapped with a warning letter because it refused to provide the FDA with records related to suppliers of components and products that it used, among other cGMP violations.