Entries by Evgeniy Makarevich

EMA is approving Zynteglo gene therapy for patients with beta-thalassemia

The Committee for Medicinal Products for Human Use (EMA) recommends granting conventional marketing authorization for Zynteglo gene therapy. This is a drug for patients with beta-thalassemia (from the age of 12) who need regular blood transfusions and who haven’t found suitable donors for stem cell transplantation. Thalassemia is a group of hereditary diseases of the […]

The first antidote to Dabigatran was approved in Russia

Boehringer Ingelheim announced the authorization of Idarucizumab in Russia. This is a specific antagonist of oral anticoagulant Dabigatran (Pradax) ⠀ Idarucizumab is intended for patients taking Dabigatran when a quick elimination of the anticoagulant effect is required, including when emergency surgery is necessary and for life-threatening or uncontrolled bleeding. ⠀ The drug was approved on […]

X7 Research at IPhEB Russia 2019

X7 Research took part in the last IPhEB Russia 2019 exhibition in St. Petersburg. IPhEB is the most Russian pharma event hosting a wide range of exhibitors in the field of pharma ingredients, finished dosage, machinery, equipment, technology and outsourcing. This event is the unique opportunity to initiate business and build partnerships in the booming […]

The WHO developed a new strategy to fight the flu

The World Health Organization adopted a new strategy to fight the flu for 2019-2030. Its goal is preventing seasonal outbreaks of the disease more effectively, improving the control over the transmission of the virus to humans from animals and preparing for the next flu pandemic, which, according to experts, is inevitable. According to Tedros Adanom […]

FDA approved Valsartan Generic 

The FDA approved a new generic valsartan to control blood pressure. It was a mean to solve the problem of reduced supplies after some pharmaceutical manufacturers recalled their valsartan drugs because of the potential risk of cancer. The FDA is reviewing the marketing application for the generic valsartan manufactured by Indian company Elkem Laboratories Ltd, […]

EMA accepts the application for authorization of Bavencio for renal cell carcinoma

The European Medicines Agency (EMA) accepted for consideration a authorization application from Merck KGaA for Bavencio (avelumab) for the treatment of patients with advanced renal cell carcinoma (CRP). The regulator is considering the application for the use of Bavencio in combination with Inlyta (axitinib), which was submitted on the results of Phase III pivotal clinical […]

Tecentriq was approved in the US for the treatment of breast cancer

Roche’s immunotherapy drug Tecentriq was approved in the United States for treatment of patients suffering from triple negative breast cancer (TNBC), which is a progress in fight with this aggressive disease. The FDA approved Tecentriq in combination with a chemotherapeutic drug Abraxane for the treatment of inoperable locally advanced or metastatic TNMP in patients with […]

For clinical trials, ‘convenience’ services to be a standard offering in 2019

The industry’s pledge to improving the patient experience drove significant change in 2018 and will continue to do so this year, with so-called “convenience” services to become standard, says Greenphire CCO, who outlines several other trends to watch. The clinical trial sector’s overall commitment to improving the patient experience was perhaps the most significant positive […]

In the US, approved a drug for the treatment of rare blood diseases

Sanofi received a Marketing Authorization from US regulatory authorities for caplacizumab (caplacizumab) for the treatment of thrombotic thrombocytopenic purpura. This is quite a serious and rare disease. Such therapy is registered only for adult patients. This decision was made after studying the results of a clinical study that was conducted with 145 patients. Clinical trial […]