Topic:

Clinical Trials

Latest Headlines

Latest Headlines

UPDATED: Startup Epirus lays claim to a PhIII success for Remicade biosimilar

A low-profile startup in Boston backed by some marquee venture groups has posted positive data from a Phase III study of its biosimilar of Remicade, a blockbuster rheumatoid arthritis drug.

Duke's CRO nabs another trial deal

As research universities around the world look to put their labs to lucrative use by launching CROs, Duke University has nailed down another development deal, teaming up with the International Stem Cell Corporation on a Parkinson's disease treatment.

Astex reports positive PhII results for leukemia drug

Dublin, CA-based Astex Pharmacueticals revealed Wednesday morning that its small molecule SGI-110 showed "clear activity" in a Phase II trial of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome. 

UPDATED: Gilead's sofosbuvir cures some of the toughest hepatitis C cases

An NIH-sponsored study of Gilead's sofosbuvir combined with ribavirin demonstrated that the experimental therapy provided a "safe and effective" interferon-free approach for even some of the toughest hepatitis C cases.

Roche's gRED sees promising results in PhII macular degeneration study

Investigators say that lampalizumab slowed progression of AMD in patients with advanced disease, shrinking the area of geographic atrophy by 20.4%. AMD is a leading cause of blindness and major market opportunity for the drug giant, which has executed a sequence of big advances in R&D.

Acura investors feel the pain as abuse-deterrence tech flops in PhII

Shares of Acura Pharmaceuticals took a drubbing overnight after the biotech reported the failure of a midstage study of a painkiller designed to reduce its appeal for abuse.

Tiny Catalyst soars after rare disease drug scores 'breakthrough' at FDA

The treatment, Firdapse, is marketed in Europe by BioMarin and is now in a Phase III study designed to win an FDA approval. And the company's shares, battered last fall after its lead drug flopped in a Phase IIb trial for cocaine addiction, instantly zoomed up 48% on the news.

Sanofi to return to FDA with new flu vaccine data

In 2009, Sanofi made its play for the seniors flu vaccine market by introducing Fluzone High-Dose. After running a trial of 30,000 people aged 65 and older, the company is ready to go back to FDA to seek a new label for the vaccine.

Rigel shares slide after another drug flops in PhII asthma study

Shares of Rigel Pharmaceuticals took a dive this morning, dropping 17% after the South San Francisco-based biotech announced that it is burying a program for allergic asthma after its drug R343 flunked a midstage study.

CRO Psi jumps into India

Switzerland's Psi is reaching into India's clinical research market, opening up shop in the country and continuing its global expansion.