Topic:

Pipeline

Latest Headlines

Latest Headlines

Novo Nordisk walks back some U.S. optimism for its next-gen insulin

Novo Nordisk is sounding a more cautious tone on Tresiba, its once-rejected new insulin. After hinting at an accelerated trip back to the FDA for the long-acting diabetes treatment, the Danish drugmaker now says it could be another few years before the injection is ready for another shot at approval.

Xencor moves on without Amgen, ditching its hopes in arthritis

Xencor has reacquired the rights to an Amgen-optioned antibody, walking away from the Big Biotech and an arthritis indication with hopes of a new path in rare disease.

Cara's pain drug clears an abuse hurdle as it trots toward Phase III

Cara Therapeutics is touting positive data from a trial in which its in-development treatment proved significantly less abuse-friendly than a commonly used opiate, results the company believes could make the drug a standout on the market.

Receptos' lead drug scores another promising PhII--this time for ulcerative colitis

San Diego-based Receptos is on a roll. After the markets closed on Monday, the biotech spread the word that its mid-stage trial for lead drug RCP1063 hit its primary endpoint for spurring remissions and clinical responses among patients suffering from ulcerative colitis in the trial. And the results quickly spurred a 37% spike in its share price, which follows a similar surge when the same drug hit its marks in a mid-stage trial for multiple sclerosis back in the summer.

GlaxoSmithKline cozies up to Five Prime for respiratory R&D

GlaxoSmithKline, facing widespread scrutiny for its underperforming respiratory business, has expanded its relationship with Five Prime Therapeutics, digging in to discover new treatments in the field.

Regulus soars on promising--but early--results for its hep C contender

Regulus Therapeutics, at work on a microRNA approach to hepatitis C, watched its shares skyrocket on positive early data for its lead candidate, which significantly reduced viral loads with a single dose.

Omeros halts a Phase II Huntington's trial over alarming rat results

Following the FDA's advice, Omeros has hit the brakes on a mid-stage human trial of its Huntington's disease treatment in light of data from a separate animal study, news that tanked the biotech's share value.

AbbVie's $55B deal for Shire is officially dead. Now what?

Shire and AbbVie have formally called it quits on a planned $55 billion merger, leaving each company to get by on the merits of its own pipeline and talk up the benefits of life without the other.

Despite a mid-stage miss, Cytokinetics is taking its ALS drug toward Phase III

Earlier this year, Cytokinetics tanked as its lead prospect, a treatment for amyotrophic lateral sclerosis (ALS), missed its primary endpoint and a slew of secondary goals in a mid-stage trial. But the drug did come through on one measure of lung function, and, upon analysis of the results, the biotech believes that could be its ticket to FDA approval.

Amgen sues to block Sanofi and Regeneron at the PCSK9 goal line

Sanofi and Regeneron have cut to the front of the line in the race to develop a new class of cardio drugs, but now rival Amgen has made a chess move of its own, filing a patent-infringement lawsuit designed to block its rivals from reaching what's expected to be a blockbuster market.