Industry news

27 July 2016

Syndax Appoints Leading Experts to Scientific Advisory Board (SAB)

Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat in multiple cancer indications, today announced that it has entered into an exclusive worldwide license agreement with UCB for UCB6352, an IND-ready anti-CSF-1R monoclonal antibody, which is expected to begin clinical trials in 2016.

China poised to make CRISPR history with first in vivo trial

EJ Lane / Fierce Pharma

A research team led by You Lu has received ethics clearance for what is expected to be the first in vivo trial using CRISPR gene editing technology. The Phase I trial is slated to be conducted at the West China Hospital.

To avoid shortages, FDA allows imports from 8 drug plants banned for quality shortfalls

Eric Palmer / Fierce Pharma

With the vast majority of drugs and drug ingredients being manufactured outside the U.S., the FDA has had to step up its international oversight and often ban products from plants that don’t meet its standards. But the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability.

Building a bulletproof CAR? Scientists engineer a built-in PD-1 shield

John Carroll / ENDPOINTS

CAR-Ts won’t be on the market before next year, but the technology arms race inspired by the prospect of a multibillion-dollar market has inspired a group of prominent investigators to design a new, 3.0 model in the lab that includes a built-in checkpoint mechanism. And it worked like a charm in mouse models of solid tumors—a critical hurdle that the key players have been struggling to clear.

26 July 2016

Clearside Biomedical, Inc. Announces Patient Treatment Comparison from the Phase 2 Trial (TANZANITE) in Patients with Macular Edema Associated with Retinal Vein Occlusion

Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage clinical biopharmaceutical company developing first-in-class drug therapies to treat blinding diseases of the eye, today reports additional top-line data from its Phase 2 clinical trial (TANZANITE). 78% of Patients Required No Additional Treatment in the Trial Arm with Concomitant Suprachoroidally Administered Zuprata™ and Intravitreally Administered Eylea®.

Your inhaler's watching you: drugmakers race for smart devices

Ben Hirschler / Reuters

Makers of inhalers to treat asthma and chronic lung disease are racing to develop a new generation of smart devices with sensors to monitor if patients are using their puffers properly.

'Sunshine' hits Europe: Pharma's doc payments now available, but numbers are far from comprehensive

Beth Snyder Bulik / FiercePharmaMarketing

The sun is finally shining on drug company payments to doctors in Europe. Under the disclosure requirement by the European Federation of Pharmaceutical Industries and Associations (EFPIA), U.K. drugmakers officially reported numbers for 2015 on June 30 and payment information across the association's 33-country coverage area has begun to trickle out.

Pfizer/Spark team gets a ‘breakthrough’ in gene therapy alliance

John Carroll / ENDPOINTS

A couple of years ago, Pfizer set up a new group to tackle the hot gene therapy field, drafting Michael Linden from King’s College to get it going. Right off the bat, the pharma giant also teamed with Spark Therapeutics – a hot player in the gene therapy field – to partner on an experimental program for hemophilia B. And now the partners can boast of a ‘breakthrough’ drug designation at the FDA to help speed their work along.

25 July 2016

Tobira’s Cenicriviroc Reduces Inflammation and Fibrosis in Animal Models of Chronic Liver and Kidney Disease Including NASH

Tobira Therapeutics, Inc. (NASDAQ:TBRA), a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases, today announced results from CENTAUR, its Phase 2b clinical trial evaluating the efficacy and safety of cenicriviroc (CVC) for the treatment of NASH in 289 adults with liver fibrosis. 

Researchers identify brain circuits that help people cope with stress

U.S. National Institute od Health

Research supported by the National Institutes of Health has identified brain patterns in humans that appear to underlie “resilient coping,” the healthy emotional and behavioral responses to stress that help some people handle stressful situations better than others. People encounter stressful situations and stimuli everywhere, every day, and studies have shown that long-term stress can contribute to a broad array of health problems. However, some people cope with stress better than others, and scientists have long wondered why. The new study, by a team of researchers at Yale University, New Haven, Connecticut, is now online in the Proceedings of the National Academy of Sciences.