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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
The top 10 drug launches of 2019
Cancer is probably the most sought-after indication in the biopharma world, but it’s missing from 2019's class of top drug launches. Instead, treatments in immunology and rare genetic diseases have grabbed the limelight.We considered two EvaluatePharma pr..
2019-06-26
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