Industry news

Russia Among Top Countries Progressing in Fight Against Non-communicable Disease

Sputnik

The World Health Organization said that Russia is one of the world’s 10 countries that have shown the best progress in the fighting against non-communicable disease this year.

Feds prioritize researcher access to health data in IT action plan

Nick Paul Taylor / Fierce Biotech IT

Federal officials are to prioritize making high-quality electronic health data more readily available to researchers over the next 5 years. Objectives include increased use of trial data in patient-focused outcomes studies, the application of health IT to improve clinical research and greater openness.

NEJM: FDA's proposed risk-disclosure guidelines still aren't enough

Beth Snyder Bulik / FiercePharmaMarketing

As the FDA again reviews its guidance on disclosing prescription drug risk information, two New England Journal of Medicine articles are suspicious that new guidelines would change much for patients.

New breast cancer solution enters preclinical trials in St. Pete

MarchMont Innovation News

Biocad, an innovative developer in St. Petersburg,  announced  the launch of a preclinical trial phase for its new breast cancer solution. The drug candidate is expected to show efficacy in fighting the disease at both early and advanced stages. 

How much more does the U.S. pay for drugs? Up to 10 times more, report says

Emily Wasserman / FiercePharma

Skyrocketing drug prices are triggering a firestorm of criticism, with lawmakers and the public calling for new reforms. A common point: Drugs cost more in the U.S. than in other countries that use cost assessments and price caps to keep a lid on costs.

UK scientists start stem cell trial of potential blindness cure

Kate Kelland / Reuters

The first patient has been treated in Britain in a pioneering trial of a new treatment co-developed by Pfizer and derived from embryonic stem cells designed for patients with a condition that can cause blindness.

World's largest reinsurer ready to insure against FDA actions

Eric Palmer / FeircePharmaManufacturing

If a pharma plant closes because of an explosion or a natural disaster, well there is business interruption insurance for that. But if it closes to deal with issues after the FDA issues a Form 483 or a warning letter, then the drugmaker is on the hook for all of the costs. Now a couple of insurance companies say they will offer something to soften such blows.

EP Vantage: Legal loopholes, price hikes set up aging meds for billions in 2020

Emily Wasserman and Tracy Staton / FiercePharma

In the land of pharma, off-patent drugs usually translate to lost profits. But things don't always shake out that way, as this week's controversy over Turing Pharma and its massive price hike on a 62-year-old drug shows. Thanks to financial maneuvers for some--and good old-fashioned brand strength for others--companies could collect billion-dollar sales for aging drugs by 2020, according to a new report from EvaluatePharma.

28 September 2015

Syndax and Merck Announce First Patients Dosed in Phase 1b/2 Clinical Trial of Entinostat and Keytruda®

Syndax Pharmaceuticals, Inc. and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the dosing of the first patients in the Phase 1b/2 clinical trial of Syndax’s entinostat in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with non-small cell lung cancer (NSCLC) or melanoma. The clinical trial, designated ENCORE 601 by Syndax and KEYNOTE 142 by Merck, is evaluating the safety, tolerability and efficacy of entinostat, an oral, small molecule that targets immune regulatory cells, combined with KEYTRUDA, an anti-programmed cell death protein 1 (anti-PD-1) antibody.

28 September 2015

Neothetics Expands Its Board of Directors With Appointments of Jeffrey Nugent and Hani Zeini

Neothetics, Inc.  (NASDAQ:NEOT) today announced that it has named  Jeffrey Nugent  and Hani Zeini to its Board of Directors.