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FDA wrath falls on Chinese OTC maker of children’s drugs
A Chinese OTC drugmaker gets the distinction of ringing in the new year as the first company to be slapped with an FDA warning letter.The FDA posted a warning letter this week for Huaian Zongheng Bio-Tech for its plant in Huaian, China, which it says makes ove..
2020-01-16
ICER gets on board with AbbVie's Rinvoq for RA but frets over 'fair pricing' of next-gen drugs
When the Institute for Clinical and Economic Review (ICER) first released its draft report on the cost effectiveness of next-generation JAK inhibitors to treat rheumatoid arthritis, it blasted all three—Pfizer’s Xeljanz, AbbVie’s Rinvoq and Eli Lilly and In..
2019-12-04
Novartis' new cell therapy facility could ease manufacturing squeeze for CAR-T med Kymriah
Novartis' big push into cell and gene therapy hasn't been the smoothest of rides, with a data manipulation scandal hamstringing Zolgensma and manufacturing concerns hurting CAR-T cancer therapy Kymriah. Could a new European facility help turn around th..
2019-12-04
FDA publicly shames Chinese drugmaker for tailor-making inspection documents
The FDA doesn’t always announce the warning letters it slaps on drugmakers, much less send out a missive from the commissioner himself. But apparently, the agency considers one set of violations serious enough to publicly call out a Chinese over-the-counter d..
2019-08-28
Chinese CDMO GenScript takes steps to be player in China's gene and cell therapy market
With Western drugmakers taking new-generation meds to China, GenScript Biotech is looking to be a key player in China’s CDMO market for biologics and cell and gene-based treatments. The Chinese company this week formally premiered a clinical supply manufactur..
2019-08-06
FDA promises 'elevated' new drug approvals, but warns of potential pitfalls: report
The FDA has approved 14 new drugs so far this year, lagging behind the 20 approvals it had charted by this time last year. Is it a sign that the FDA is becoming more cautious in the wake of Scott Gottlieb’s departure? After all, it was under his tutelage that..
2019-07-18
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