Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Dynavax initiates PhIII study it hopes will quell FDA's safety concerns

FDA and EMA requests for more data on hepatitis B candidate Heplisav have set Dynavax Technologies back time and again. Now, Dynavax is embarking on a new trial it hopes will address some of those safety concerns.

Little Lexicon posts positive diabetes data as rival pharma giants race ahead

The newly downsized Texas-based Lexicon Pharmaceuticals says it nailed promising data on its experimental diabetes drug, positioning it for a late-stage study that could leave it poised to compete with a full lineup of rival treatments already brought to the market by a group of pharma giants.

Roche adds a slate of PhIII schizophrenia trial failures to bitopertin's obituary

A few months ago Roche put out the word that its schizophrenia drug bitopertin had flunked the first two Phase III studies in a lengthy lineup of clinical trials. And today the pharma giant almost completed its obituary for a drug program that had been touted as one of Roche's top blockbuster prospects, adding a long slate of trial flops to the record.

J&J axes a late-stage Botox rival, chopping project staffers

J&J says that it is discontinuing work on the neurotoxin program for PurTox, its long-acting successor to Botox, even though its Mentor subsidiary has wrapped three late-stage studies on the aesthetic therapy for smoothing out facial wrinkles.

Cytos hits the self-destruct button as PhIIb asthma study bombs

After 19 years of fruitless drug development work capped by the failure of a Phase IIb study of its experimental asthma therapy, Cytos Biotechnology is ready to call it quits.

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.