Industry news

New tools for turning genes into drug factories

Arlene Weintraub / FierceBiotech

Synthetic biologists have long dreamed of designing genetic circuits in the body that can produce drugs in response to environmental cues. But it’s been a challenging task. Now scientists at Rice University say they’ve created a toolkit of gene “promoters” that can turn genes on and off at command.

FDA approves first treatment for breast cancer with a certain inherited genetic mutation

U.S. Food and Drug Administration

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Patients are selected for treatment with Lynparza based on an FDA-approved genetic test, called the BRACAnalysis CDx.

The coming of age of gene therapy: A review of the past and path forward

U.S.National Institute of Heath

After three decades of hopes tempered by setbacks, gene therapy—the process of treating a disease by modifying a person’s DNA—is no longer the future of medicine, but is part of the present-day clinical treatment toolkit. The Jan. 12 issue of the journal Science provides an in-depth and timely review of the key developments that have led to several successful gene therapy treatments for patients with serious medical conditions.

Russia approves the mechanism for introducing the medicines into circulation

GMP News

A draft federal law on the introduction of medicinal products for human use into civil circulation was prepared by the Russian Ministry of Health. The bill proposes to establish a more effective legal regulation of relations associated with the elaboration, application and enforcement of requirements in the area of circulation of medicinal products for human use, namely, by establishing a mechanism for release control of medicines coming into the civil circulation in Russia.

Drug discovery IT solutions will reach $5.3 billion globally by 2020

GMP News

The latest analysis, Growth Insights – Global Pharmaceutical Drug Discovery IT Solutions Market, Forecast to 2020, by Frost & Sullivan highlights the growing interest in big data analytics and artificial intelligence (AI)-based solutions.

Clinical trials of Russian polio vaccine will be completed by mid-2018

GMP News

Russian scientists plan to complete the clinical trials of domestically developed inactivated polio vaccine by mid-2018 and are preparing the documents required for the registration of this drug. This was announced by Aidar Ishmukhametov, the Director of M.P. Chumakov Federal Scientific Center for Research and Development of Immunobiological Products of Russian Academy of Sciences.

Russia’s drugs exports in January – November 2017 amounted to 19 billion rubles

GMP News

In the first 11 months of 2017, the exports of medicinal products from Russia (excluding the shipments to EAEU) reached 19.0 billion rubles (including the customs duties). This means that, when calculated in the Russian currency, the increase over the same period of 2016 was only 0.4%. However, the mere fact of positive dynamics is quite encouraging, as the results for January-October were much gloomier (at that time, the long-term growth rate was -2.2%).

Ferring announced a research collaboration with the Chinese Academy of Sciences

GMP News

Ferring Pharmaceuticals and the Chinese Academy of Sciences (CAS) today announced a long-term collaboration to advance basic and translational research in reproductive medicine through the development of novel product candidates and therapeutic strategies.

Russian State Duma to ease imports of APIs

Remedium

The Russian national Parliament (State Duma) plans to approve a bill that will ease imports of active pharmaceutical ingredients (APIs) to the country, according to press-service of the Russian Duma, reports The Pharma Letter’s local correspondent.

11 January 2018

Genentech, Syndax expand HDAC-PD-L1 combination pact

Nick Paul Taylor / FierceBiotech

Genentech and Syndax have expanded their exploration of the effects of combining HDAC and PD-L1 inhibitors. The new agreement clears the Roche subsidiary to test its Tecentriq in combination with Syndax’s entinostat in a subset of breast cancer patients.