Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Sarepta rockets up after mapping a shortcut to the FDA with DMD hopeful eteplirsen

After keeping investors on a roller coaster ride of speculation for months, Sarepta says it now plans to shoot for an accelerated approval of its Duchenne muscular dystrophy drug eteplirsen. The biotech says it will file for an early approval by the end of this year after launching a slate of new clinical trials to get the data that the FDA is looking for.

Zafgen tees up an $86M IPO for eye-catching obesity drug

Zafgen has been turning heads with some jaw-dropping results from its mid-stage studies for a promising new obesity drug. And now the biotech hopes to parlay its eye-catching, if risky, technology into an $86 million IPO.

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.