Topic:

Clinical Trials

Latest Headlines

Latest Headlines

Novo Nordisk defers dream of expanding Victoza label after PhIII falls short

Novo Nordisk has hit a roadblock in its drive to expand the label for Victoza to cover use in Type 1 diabetics. The snag arose when Victoza failed to deliver hypoglycaemic benefit experienced by Type 2 diabetics in people with the other form of the disease in a Phase III trial.

Vital Therapies' shares crash on news of a PhIII failure

Vital Therapies has joined the growing list of biotechs crushed by a single catalyst after it reported late Friday that their cell-based therapy for liver damage had failed a late-stage study.

Vernalis cuts the cord on a late-stage pain drug after a trial flop

An in-development pain treatment from Vernalis missed its main goal in a proof-concept study, leading the U.K. drugmaker to back away from a drug it once believed could bring in more than $500 million a year.

Bavarian Nordic to start PhI trial of RSV jab

Things are heating up in the race for a respiratory syncytial virus (RSV) vaccine.Novavax reported Phase II results for its investigational vaccine just a week ago, and now, Danish biotech Bavarian Nordic is starting a Phase I trial of its candidate.

UPDATED: Heard the latest Kite Pharma rumor? CEO says it ain't so

Kite CEO Arie Belldegrun has a simple message for investors this morning: Relax.

Hunting fast OK in lung cancer, Roche racks up a positive PhII for 'atezo'

Roche is spotlighting another success for its PD-L1 checkpoint drug atezolizumab, with company execs applauding a positive finish in a big mid-stage study in non-small cell lung cancer. The news follows a string of steady pipeline advancements for a drug that has emerged as the pharma giant's biggest single late-stage blockbuster contender.

Adynxx eyes an IPO, late-stage program after pain drug clears a PhII hurdle

Adynxx says that their second shot at statistically significant results in a midstage study for their lead pain drug proved the charm. The San Francisco-based biotech didn't post any data, but CEO Rick Orr said that the drug hit the primary endpoint without raising any red flags on the safety side.

Merck Ebola vaccine posts 100% efficacy in PhIII

Merck's Ebola vaccine, developed in tandem with NewLink, has protected 100% of patients from Ebola infection, according to interim results published in The Lancet on Friday.

Lexicon rockets up after a positive PhIII study sets up an NDA

Shares of Lexicon Pharmaceuticals soared 35% this morning after The Woodlands, TX-based biotech claimed a win in Phase III for one of its lead drugs. The biotech said that telotristat etiprate proved effective against rare cases of carcinoid syndrome, a condition triggered by neuroendocrine tumor cells that causes severe diarrhea.

Synergy Pharma jumps as second PhIII scores a success against constipation

Synergy Pharmaceuticals handed over a fresh set of Phase III data from its second pivotal study of plecanatide, confirming the first round of positive efficacy results for chronic constipation and delivering a slightly improved safety profile that should help as the biotech makes a run at a drug approval and market launch.