Industry news

After disappointing 2016, new drug approvals roared back to life in 2017

Amirah Al Idrus / FierceBiotech

New drug approvals all but screeched to a halt in 2016, with a measly 22 new OKs after a pair of bountiful years. But the FDA wasted no time in 2017, signing off on 12 drugs in the first quarter alone—besting its record for the same period of any year in recent history.

Biotech stocks fail to lift on so-so J.P. Morgan conference's first day

Ben Adams / FierceBiotech

Last year, things were pretty quiet out of the J.P. Morgan Healthcare Conference: few deals, few major updates. That seemed to set the tone for much of the year, at least on the M&A front.

10 January 2018

Syndax Pharmaceuticals Announces Clinical Collaboration to Evaluate Entinostat in Combination with anti-PD-L1 Cancer Immunotherapy in Breast Cancer

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 a new clinical collaboration with  Genentech , a member of the Roche Group. As part of the collaboration, the two companies will evaluate the combination of Syndax's entinostat, an oral, small molecule, class I HDAC inhibitor, and  Genentech's  programmed cell death ligand 1 (PD-L1) blocking antibody, atezolizumab (TECENTRIQ^®), in patients with second-line hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) metastatic breast cancer.

Russian President signs the Federal Law on introduction of drug labeling

GMP News

Russian President Vladimir Putin signed the Federal Law “On amendments to the Federal law “On Circulation of medicines.” The law provides for the establishment of state information system to monitor the movement of medicinal products for human use from the manufacturer to the final consumer by using the means of identification with regard to medicinal products in order to ensure the quality control of medicinal products for human use, that are in circulation, and protect the legal trade from falsified, counterfeit, and substandard medicines.

A pharmaceutical technopark is planned to be established in the Baikal region

GMP News

A meeting of Scientific Coordination Council under the Governor of the Irkutsk region was held in the Government of the Irkutsk region. The meeting was attended by Sergey Levchenko, the head of the region, and discussed the establishment of an innovative chemical and pharmaceutical technopark.

The Federation Council of Russia ratifies the MEDICRIME Convention

GMP News

Russian senators have approved the Federal Law “On ratification of the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health” (MEDICRIME Convention).

FAS will support Russian manufacturers in the registration of prices

GMP News

The head of Federal Antimonopoly Service (FAS) of Russia Igor Artemyev met with the executives of Pharmstandard PJSC and BIOCAD CJSC, two major Russian pharmaceutical companies. At their meeting, the parties discussed the ways to support the domestic pharmaceutical manufacturers in the draft Decree of the Government of the Russian Federation “On State Registration and Re-Registration of Maximum Ex-Works Prices for Medicinal Products Included in the List of Vital and Essential Drugs” which is currently being elaborated.

Pharmaceutical industry grew by 80% in Kaluga region

GMP News

On December 25, in the media center of Vest, a newspaper in Kaluga, the Governor of Kaluga region Anatoly Artamonov held a press conference on the results of outgoing year. In his opening remarks, the head of the region presented the preliminary figures for 2017 to the media community of the region. The pharmaceutical industry demonstrated a growth of 180% compared to the last year.

The top 10 pharma R&D budgets in 2016

Ben Adams / FierceBiotech

Last year, biopharma won its share of new drug approvals, though not as many as we're used to in the U.S., as research spending came to fruition. But drugmakers also suffered a number of R&D setbacks, cut research staff, rejigged their operations and refocused their pipelines.

Researchers in Tomsk develop a fundamentally new anti-inflammatory drug

GMP News

Researchers from Iphar, a Tomsk-based company, are working on an anti-inflammatory drug with a fundamentally new mechanism of action that will ensure its safe use.