Industry news

EMA published a new guidelines on evaluation of advanced therapy medicines

GMP News

The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers of these medicines – often small and medium-sized enterprises (SMEs) or academic spin-offs – navigate the regulatory process in the EU.

Russia backs medical IT developers

Marchmont Innovation News

Russia’s Advanced Research Fund (ARF) has been boosting support for developers of IT projects to be used in medicine. “We’re witnessing a growing number of IT projects in the field of medicine. These primarily include mobile apps for telemedicine, nervous disorder diagnostics by analyzing the way a person speaks, rehabilitation following strokes and brain damages, and many others,” ARF Deputy CEO Sergei Garbuk was quoted as saying. He is in charge of the IT department at the Fund. 
 

MIT study finds that 14% of trials see approvals—higher than first thought

Ben Adams / FierceBiotech

A 14% hit rate for drug approvals coming out of clinical trials might not sound great, but researchers at the Massachusetts Institute of Technology say this is much higher than they thought, and that approvals are bouncing up again after a period of decline.

Pfizer and ICMR will create an antimicrobial resistance centre in India

GMP News

The Indian Council of Medical Research (ICMR) and Pfizer have announced a partnership to set up a centre aimed at combating growing antimicrobial resistance (AMR) in India. The centre will help in three basic things – expanding ICMR’s Antimicrobial Stewardship Programme across the country in a phased manner with the focus on smaller in-patient centres and enhancing its existing AMR Surveillance Programme by training specialists to run an expanded network.

Russia increases its budget for antiretroviral drugs by 20% in 2018

GMP News

The Russian Ministry of Health wants to prevent disruptions in the supplies of antiretroviral drugs. This year, the budget of the Ministry allocated 21.6 billion rubles for this purpose, which is 20% more than in 2017 (17.8 billion rubles), according to the press service of the Ministry of Health.

Hospitals Launch Their Own Generic Drug Company

BioPharm International

A consortium of four healthcare groups, citing frustration with ongoing shortages and high costs of generic medications, announced on Jan. 18, 2018 the formation of a not-for-profit generic drug company. The healthcare groups, Ascension, Intermountain Healthcare, SSM Health, and Trinity Health—working in consultation with the US Department of Veterans Affairs (VA)—represent more than 450 hospitals in the US.

PhRMA points finger at insurers on new drug cost website for consumers

Beth Snyder Bulik / FiercePharma

PhRMA wants to keep talking about drug costs. So as part of its ongoing “Let’s Talk About Cost” marketing campaign, the pharma trade organization launched a new consumer-facing website to address the issue and explain the industry's perspective.

01 February 2018

Syndax Announces Immuno-Oncology Clinical Trial Collaboration with AstraZeneca

Syndax Pharmaceuticals, Inc.  ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, today announced a new clinical collaboration with AstraZeneca  to evaluate the safety and efficacy of AstraZeneca's durvalumab, a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with SNDX-6352, Syndax's monoclonal antibody inhibitor of Colony-Stimulating Factor 1 Receptor (CSF1R), across a variety of solid tumors.

WHO published new insights on antibiotic resistance

GMP News

WHO’s first release of surveillance data on antibiotic resistance reveals high levels of resistance to a number of serious bacterial infections in both high- and low-income countries.

Russian Ministry of Industry and Trade takes steps to reduce drug prices

GMP News

The Ministry of Industry and Trade of Russia prepared a draft law that would allow the manufacturers of medicinal products and medical devices to minimize their payments of value added tax for imports and sales of medical products in the Russian Federation and, thereby, reduce the final price of these products for consumers.