Industry news

State Duma adopted a bill to simplify registration of drugs

GMP News

It will be possible to register drugs that have the same international nonproprietary names, but different trade names, and being manufactured at the same site. The corresponding government bill No. 327290-7 on amendments to the Federal Law “On Circulation of Medicines” was adopted by the State Duma in the third reading.

Today’s realities in the development of local and contract manufacturing

GMP News

The representatives of pharmaceutical companies met at the forum of the Adam Smith Institute where they shared their views on the development of local and contract manufacturing. Victor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers, said that Russian manufacturers continue to consider the quality of their products as the most important issue.

Russian Ministry included the Kirov region biotech cluster in its register

GMP News

The Ministry of Industry and Trade of Russia confirmed that the industrial biotechnology cluster of the Kirov region and its specialized organization “The Association of Industrial Biotechnology Cluster” comply with the requirements approved by the Decree of the Russian Government No. 779, dated July 31, 2016.

22 May 2018

Evofem Biosciences Announces Pricing of Public Offering of Common Stock and Warrants

Evofem Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, announced today the launch of an underwritten public offeringEvofem Biosciences, Inc., (NASDAQ: EVFM) ("Evofem" or the "Company"), a clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health, announced today the pricing of an underwritten public offering of up to 8.5 million shares in aggregate of common stock or, in lieu of shares of common stock, pre-funded warrants exercisable for shares of common stock, and accompanying common warrants to purchase an aggregate of 1.7 million shares of common stock.of $40.0 million of its common stock. All of the shares in the offering are to be sold by Evofem.

Russian pharmaceutical market: stability in unstable environment

GMP News

According to DSM Group, in 2017, the Russian market was worth 1629 billion rubles, which 8% higher than in 2016. For the first time in three years, the market grew in dollar- and euro-denominated terms. In physical terms, the market growth is similar to the dynamics in value terms. Therefore, the factor of higher prices played virtually no role in expanding the market volume. In 2017, the main driver was the increase in the actual consumption of medicinal products, i.e., the growth in terms of sold packages.

New Processing System Streamlines Cell Therapy Manufacturing

BioPrarm International

The Sefia S-2000 cell processing system, a multifunctional technology from GE Healthcare, streamlines the isolation, harvesting, and final formulation steps in the cell therapy manufacturing process by allowing operators to conduct multiple cell therapy manufacturing steps with one instrument.

European and Indian Pharmacopoeias Coordinate on Quality Standards

BioPrarm International

The European Directorate for the Quality of Medicines and Healthcare (EDQM), the European Pharmacopoeia Commission (Ph. Eur.), and the Indian Pharmacopoeia Commission (IPC) held a symposium on April 26 in Mumbai to discuss how the two pharmacopeias could work together to pool resources to improve quality standards for medicines and to harmonize activities.

Japanese firms open rehab center in Russia

Remedium

Japanese firms have opened a physical rehabilitation center in Vladivostok in Russia's Far East as part of the plan for economic cooperation between the 2 countries. JGC, an engineering firm, and Hokkaido-based Hokuto Social Medical Corporation, invested in setting up the rehabilitation center. JGC has experience in building hospitals.

Start-up pushes for artificial intelligence to support medical diagnostics

Marchmont Innovation News

TeleMD, a Russian start-up, is developing a software platform that uses artificial intelligence (AI) for cancer diagnostics and prognostication. Over the past few months the start-up has been focused on fine-tuning the platform’s image recognition functionality for cancer diagnostics, and also on making the solution scalable for medical specialists from across disciplines to be able to analyze heterogeneous medical data. 

17 May 2018

Syndax Announces Updated Results from Phase 2 ENCORE 601 Trial of Entinostat in Combination with KEYTRUDA® (pembrolizumab)

Syndax Pharmaceuticals, Inc.  ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced updated results from multiple cohorts of the ongoing Phase 2 ENCORE 601 trial of entinostat in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1) therapy. This data will be presented at the  American Society of Clinical Oncology  ( ASCO ) Annual Meeting being held  June 1-5, 2018  in  Chicago, Illinois .