Industry news

Svetlana Akselrod from Russia joins the leadership team of WHO

GMP News

Svetlana Akselrod, an employee of the Department of International Projects in Healthcare, Institute of Leadership and Healthcare Management, Sechenov University, joined the new leadership team of WHO.

The Chinese Government set new rules to speed up drug approvals

GMP News

China will encourage innovation in drugs and medical equipment by expanding the reform of review and approval system in the medical sector, according to a guideline recently issued by the General Office of the Communist Party of China Central Committee and the General Office of the State Council.

Russian government introduces rules for distance sales of medicinal products

GMP News

The government introduced the rules for distance sales of medicines in order to eliminate the trading in counterfeit products. This was announced at a government meeting by the Prime Minister Dmitry Medvedev.

Scientists reverse heart failure via newly discovered regeneration pathway

Carly Helfand / Fierce Pharma

A signaling pathway in the body called Hippo is well known in scientific circles for its potential role in cancer, but now scientists at Baylor believe they have found another place where manipulating this system could be beneficial—the heart.

Most new cancer meds haven't proved they can improve or extend lives: study

Carly Helfand / Fierce Pharma

Sixty-eight cancer drug indications won European approval between 2009 and 2013—but most of them did so without showing they could extend or improve life, a new study shows.

EMA, facing a Brexit-shaped hole, moves to add staff

Nick Paul Taylor / Fierce Pharma

The European Medicines Agency (EMA) has put out a big tender for temporary workers. EMA’s call for extra staff comes as it is bracing itself for the likely loss of employees when it moves from its current home in London.

Russia rises in latest global competitiveness report

Marchmont Innovation News

Russia rose five spots to #38 out of 137 countries in the latest edition of the World Economic Forum’s (WEF)  Global Competitiveness Index , with its score increasing to 4.64 from 4.51 in last year’s report, the US-Russia Business Council reported, citing the source. 
 

05 October 2017

Syndax Announces Dosing of First Patient in Pivotal Trial of Entinostat for the Treatment of Advanced or Recurrent Breast Cancer in Japan by Partner Kyowa Hakko Kirin

Syndax Pharmaceuticals, Inc.  ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, today announced that Kyowa Hakko Kirin Co., Ltd (Kyowa Hakko Kirin), its  Japan  and  Korea  sublicensee, has now dosed the first patient in a randomized, double-blind, placebo-controlled, pivotal Phase 2 trial of entinostat (designated KHK2375 by Kyowa Hakko Kirin), Syndax's oral Class-I histone deacetylase inhibitor, in combination with exemestane versus exemestane plus placebo in Japanese patients with advanced or recurrent hormone receptor-positive (HR+), human epidermal growth factor receptor two-negative (HER2-) breast cancer. Enrollment of the first patient in this trial triggers a  $5 million  milestone payment to Syndax from Kyowa Hakko Kirin.

Supplies of APIs from China and India to Russia have declined by 5%

GMP News

In January – August 2017, the imports of active pharmaceutical ingredients (APIs) to Russia amounted to 48.9 billion rubles (in prices set for release to free circulation, including VAT).

Russian Ministry receives authority to approve drugs for circulation in EAEU

GMP News

The Russian Government amended the Statute of the Ministry of Health of the Russian Federation. The corresponding Decree No. 1159 was signed by Prime Minister Dmitry Medvedev on September 25, 2017.