Topic:

Clinical Trials

Latest Headlines

Latest Headlines

UPDATED: Watch out, Gilead. Merck is mounting a hep C combo comeback

Merck may be late to the blockbuster party with its new hepatitis C drugs, but the pharma giant is moving fast with a top contender boasting high cure rates.

Merck KGaA lung cancer vaccine gets a second shot with start of PhIII trial

Merck KGaA has breathed some life back into its lung cancer vaccine, which many wrote off after it tanked in a Phase III trial in late 2012. After vowing to make a renewed effort to find some value in the jab last September, this week the company announced the start of a new Phase III study.

FDA drops a hold on Halozyme study

The latest news sliced only 3% off the biotech's share price.

UPDATED: Alkermes hits PhIII goal line with 'blockbuster' long-acting schizophrenia drug

Alkermes has crossed the finish line in a Phase III schizophrenia study of a long-acting version of Abilify, picking up the statistically significant results needed to back a new drug application later in the year.

Puma surges as neratinib beats Herceptin in head-to-head breast cancer study

Puma Biotechnology is boasting that its experimental cancer drug neratinib bested Herceptin in a head-to-head study of HER2-positive breast cancer when used ahead of surgery.

Agios shares spike on enthusiastic response to small, early-stage leukemia study

Agios Pharmaceuticals was the biotech canary in the coal mine when it went public last year. Not only did it survive its IPO, it thrived, helping lure dozens of other biotechs into the market with solid proof that investors would buy into a drug developer with no human data in the portfolio.

Clinipace signs up to get a brain-stimulating device on the U.S. market

Global CRO Clinipace has agreed to manage clinical trials for Nexstim as the Finnish devicemaker works toward FDA approval for its neurostimulation therapy.

UPDATED: Pfizer's flagship palbociclib stymies cancer progression but falls short on survival

In the first detailed glimpse of palbociclib's impact on overall survival--a key feature to the future prospects of this flagship program--the therapy has failed to demonstrate a statistically significant improvement in extending patients' lives after an initial assessment.

UPDATED: Two deaths force MSK to hit the brakes on engineered T cell cancer study

Investigators are halting recruitment for a small study using T cells reengineered with chimeric antigen receptors against CD19-positive B cells for aggressive non-Hodgkin lymphoma, triggering concerns about the potential fallout at Juno Therapeutics, the biotech formed to commercialize the effort.

Amgen's closely watched melanoma prospect misses PhIII survival endpoint

Amgen's cancer-fighting viral vaccine has been rolling through Phase III, producing a series of positive results. But after missing a secondary endpoint in overall survival, the California-based biotech's hot prospect now has a big blot on its resume.