Industry news

Talking cents in pharma? PhRMA finally launches campaign to discuss drug costs

Beth Snyder Bulik / FiercePharmaMarketing

Probably one of the last things the pharma industry wants to talk about today is the cost of drugs. Or does it? Industry trade group PhRMA has launched new advertising meant to tackle the issue head-on.

King cancer: The top 10 therapeutic areas in biopharma R&D

John Carroll / Endpoints News

It’s not going to come as a surprise to anyone who’s been paying attention to drug R&D trends that cancer is the number 1 disease in terms of new drug development projects. But it is amazing to see exactly how much oncology dominates the industry as never before.

Russia approves a draft law for monitoring the circulation of medicines

At its meeting on July 13, the Russian government approved the draft federal laws “On Amendments to the Federal Law “On Circulation of Medicines” and “On Amendments to the Code of the Russian Federation on Administrative Offenses.”

Russian scientists developed 26 innovative cancer drugs

GMP News

These drugs should improve the quality of life for the patients, including those with advanced forms of cancer. This was announced by the Russian Minister of Health Veronika Skvortsova at a meeting of the Council on Guardianship under the Government of the Russian Federation.

FAS of Russia advocates the “third wheel” rule transformation

GMP News

Igor Artemyev, the Head of the Federal Antimonopoly Service of Russia, spoke about his agency’s position on the current use of “third wheel” rule in public procurement of drugs, when a foreign company can no longer participate in a tender if there are two Russian companies.

By the end of 2020 manufacturers in EAEU states have to decide on drug regisration

GMP News

All documents of the Eurasian Economic Commission elaborated and enacted from May 6, 2017, are directly applicable documents. This means that they do not require the adoption of any national regulations governing their application in each of the member states. As a result, from May 6, all stages of developing, manufacturing, and assessing the medicinal products in preclinical studies and clinical trials should be conducted in accordance with the requirements of the relevant decisions adopted by the Commission.

Russia may authorize compulsory licensing of medicinal products this year

GMP News

The procedure for compulsory licensing of drugs may be introduced in Russia as early as this year, said Igor Artemyev, the Head of the Federal Antimonopoly Service.

11 July 2017

Preclinical Results Support Entinostat's Role in Targeting the Tumor Microenvironment to Enhance Immune Checkpoint Therapy

Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications, in collaboration with The Wistar Institute and Indiana University Melvin and Bren Simon Cancer Center, today announced the publication of a preclinical report demonstrating that entinostat, Syndax's oral, Class-I histone deacetylase inhibitor, enhances the antitumor effect of PD-1 (programmed death receptor-1) blockade through the inhibition of myeloid derived suppressor cells (MDSCs).

11 July 2017

Clearside Biomedical Announces First Patient Randomized in Phase 2 Clinical Trial of CLS-TA Used Together with Eylea in Patients with Diabetic Macular Edema

Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced the enrollment of the first patient in a phase 2 clinical trial (“TYBEE”) of CLS-TA for suprachoroidal administration (“suprachoroidal CLS-TA”), Clearside’s proprietary suspension formulation of the corticosteroid triamcinolone acetonide, used together with intravitreally administered EYLEA® (aflibercept) (“intravitreal Eylea”) for the treatment of diabetic macular edema (“DME”).

Personalized cancer vaccines stake their claim to the next frontier in immuno-oncology

John Carroll / Endpoints News

Two small human studies using personalized cancer vaccines engineered with mutant proteins that collectively create a unique thumb print which can be used to identify and target cancer cells for a precision attack by the immune system have demonstrated strong potential in a select number of cases. And their early successes — outlined in Nature today — are outlining a path forward that many academic and industry researchers believe represents one of the next big steps forward for combinations using the leading PD-(L)1 therapies now on the market.