Former US FDA Commissioner Scott Gottlieb said that despite the $500m Lilly took in from sales of Lartruvo, the company probably lost money with the costs of R&D and withdrawing the drug from the market.
While Eli Lilly & Co. made $500m in sales on its now-withdrawn soft tissue sarcoma drug Lartruvo (olaratumab), former US Food and Drug Administration commissioner Scott Gottlieb does not think the company is obligated to return the money it took in from the product.
Following the withdrawal of Lartruvo, which had reached the market under accelerated approval, some industry critics suggested that Lilly should...
Exploring How Everyday Industrial Compounds Enter Our Systems, Their Health Implications, and the Ongoing Quest for Safer Alternatives .
Brazilian regulator Anvisa is relying on the decisions of its foreign counterparts as a means of ensuring more quality medicines are made available in the country.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Brazil has also published its recent regulatory reliance regulations in English, a move designed to increase confidence in its decisions as it presses on with aligning its national practices with global best practices.
The US FDA commissioner also said the hub is looking for an executive director who will work with the CBER and CDER heads, who will serve as co-leads.
The FDA and sponsors of two new accelerated approval drugs for PBC have taken steps in study design, initiation and reporting transparency to ensure timely completion; Intercept’s COBALT trial of obeticholic acid was negatively impacted by product safety labeling changes and a high crossover rate to commercial drug.
