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Coming back to the SPIEF’17, our colleagues from Sechenov University signed the cooperation agreement in the scientific and educational field with biotechnical company Biocad. The objective of this cooperation is the development of collaborative educational programs for specialists in clinical trials sphere, also for the establishment of relevant world-class scientific-educational projects. Biocad chief executive officer…
SPIEF passed last week in Saint-Petersburg. There was an interesting topic for us, we should talk about. The subject of antibiotic-resistance growth and efficacy decrease was established on forum’s website. WHO says this issue caused by self-treatment patients and doctors unable to treat antibiotics properly. In investor’s point of view this problem appears due to…
In 2016 EMA annual report, that recently was in the spotlight of our news section, the agency seemed very proud of joint (EMA-FDA-PMDA) accelerated approval procedure existence and execution. Yet, industry also needs it to be reviewed from external point of view to consider all the risks and benefits. Products came to market as FDA…
Every decent regulatory agency urges to assure pharma industry that it’s activity is guided by an effort to help, but not by an unbearable will to punish and restrict. That’s why every year EMA issues the annual report on its activities in all regulatory areas. In recently published 2016 report, among many other important points,…
Last week FDA has approved Keytruda (pembrolizumab) a special treatment of cancer with particular genetic feature (biomarker). This is the first case of treating cancer based on the biomarker, not tumor affected body part. Keytruda is directed to the treatment of adults and children with unresectable or metastatic tumors, which were identified with biomarker MSI-H…
Successful approval does not always guarantee unconditional and easy profit for pharma industry. US FDA approved 222 novel therapeutics through 2001 to 2010. Among them, 183 (82,4%) were pharmaceuticals and 39 (17,6%) were biologics. But many of those approvals faced safety issues during the postmarket period. A cohort study of all novel therapeutics approved by…