Latest Headlines

Latest Headlines

Xenon's Teva-partnered pain drug flunks a test in osteoarthritis

Xenon Pharmaceuticals' Teva-partnered treatment for osteoarthritis pain missed its goals in a Phase IIb trial, a failure the biotech believes won't derail the drug's development in other indications.

UPDATED: Roche heralds PhIII successes for MS, but some tough rivals lie in wait

Roche heralded the late-stage success of two big trials for its multiple sclerosis drug ocrelizumab today, which they say puts them on a straight road to regulatory filings for the injectable in early 2016. But even under the best-case scenario for the future, the Big Pharma player will face a tough task squaring off against the new oral drugs that have been divvying up this big market recently.

Egalet's pain pill is tougher to abuse than Purdue's morphine tablet, study shows

Egalet's in-development pain pill met its goals in a study designed to prove its abuse-deterrence, beating out a rival treatment from Purdue Pharma as it heads toward an FDA filing.

Sarepta submits its DMD drug for FDA scrutiny, on the heels of BioMarin

Sarepta, ending a protracted process that may have cost its last CEO his job, submitted its treatment for Duchenne muscular dystrophy to the FDA, setting the stage for a possible approval early next year.

Vitae suffers another stinging setback as lead diabetes drug fails in PhII

Vitae Pharmaceuticals has slammed into another setback. The small biotech's lead drug, the diabetes therapy VTP-34072, failed the first leg of a mid-stage study executed by Boehringer Ingelheim.

Celladon pulls the plug on R&D after a crushing gene therapy failure

Celladon is circling the drain, suspending all research tied to its failed gene therapy and again halving its payroll as management searches for a sale and flirts with liquidation.

Aquinox's bladder pain drug misses the mark in Phase II

Aquinox's lead drug failed its main goal in a Phase II trial on bladder pain syndrome, but the company believes its oral treatment showed enough to promise to merit further study.

Catabasis pulls off a $60M IPO as biotech's Wall Street window stays open

Catabasis, at work on treatments for muscular dystrophy and high cholesterol, raised $60 million in an IPO, cashing in on investors' continued enthusiasm for bets on biotech companies.

Alcobra's drug misses the mark in Fragile X trial after flunking in ADHD

Alcobra's lead drug failed to help patients with the rare Fragile X disorder focus their attention in a Phase II study, a clinical setback that comes on the heels of a Phase III failure in attention deficit hyperactivity disorder.

Breakthrough anti-anticoagulants from Boehringer, Portola post stellar PhIII data

Portola Pharmaceuticals has laid out the last batch of Phase III data on its "breakthrough" anti-anticoagulant andexanet alfa, filling in the numbers that will be reviewed by regulators considering the biotech's upcoming pitch for marketing approval. And right alongside that announcement comes the latest numbers from Boehringer Ingelheim's breakthrough program for idarucizumab, which is already under review as an antidote to its blockbuster Pradaxa.