Entries by Evgeniy Makarevich

A new drug for the treatment of migraine may appear in Europe

The Expert Council of the European Medicines Agency recommended that regulatory authorities approve the preparation of galcanesumab, developed by the American company Eli Lilly for the treatment of a migraine. Clinical studies show that the drug is effective in reducing the number of attacks of a headache. Galceanumab is a monoclonal antibody specific for the […]

The drug for the treatment of autoimmune skin disease received the status of “breakthrough therapy”

The US Food and Drug Administration (FDA) assigned the status of “breakthrough therapy” for the oral drug of JANUS-kinase 3 inhibitor class (JAK3) held by American pharmaceutical company Pfizer. The drug is designed to treat focal alopecia, a chronic autoimmune skin disease that causes hair loss on the scalp, face or body. Assigning the status […]

Why people aren’t interested in being part of clinical trials?

According to a recent national survey of consumers and physicians conducted by Memorial Sloan Kettering Cancer Center, only about 35% of people would consider taking part in one of clinical trials. Finding participants is critical, so that trials are large enough to show that a treatment really could work on a large population. Shortages of […]

X7 Research will take part in the annual BIOTECHMED forum 2018

Dear colleagues, our company X7 Research will take part in the annual BIOTECHMED forum! From 9 to 11 September 2018 in Gelendzhik the third forum will be held – BIOTECHMED. The event will traditionally take place with the support of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of […]

FDA warning letter to the Indian drug manufacturer Goran Pharma

FDA has published a warning letter to the Indian drug manufacturer Goran Pharma after conducting an inspection. GDA has revealed non-complying with the principles of current good manufacturing practice (CGMP) as they have found serious drawbacks such as inadequate raw material quality control (identification of active ingredients and excipients from various suppliers), the absence of […]

FDA statement on probiotics

On the 16th of September there has been published a new statement by FDA Commissioner Scott Gottlieb, M.D. This time the statement revealed the problem of regulating the market of products containing microorganisms. Nowadays as never ever before consumers all over the world know the idea of “good” or “helpful” bacteria which are supposed to […]

III and IV Phases of clinical trials

III Phase of clinical trials If the drug is effective and safe in Phase II, it is examined in Phase III. Clinical Phase III trials are carefully controlled studies designed to determine the safety and efficacy of a drug under conditions close to those in which it will be used if it is approved for […]