Looking past FDA snub, Portola touts new Andexxa data

Interim results from a real-world study showed the Factor Xa inhibitor antidote effectively stopped bleeding in patients on blood thinners.

By Ned Pagliarulo • Aug. 30, 2016

Rigel makes comeback with Phase 3 data

Investors were cheered by the positive results for Rigel's low platelet count drug, although some had hoped for stronger data. 

By Lisa LaMotta • Aug. 30, 2016

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

Trial failure dashes Vectura's hopes for wider use of asthma drug

The British drugmaker aimed to market its asthma treatment for COPD in Europe, but the drug failed to demonstrate superiority over an existing option. 

By Ned Pagliarulo • Aug. 30, 2016

CardioCell offers bright spot in stem cell development

Phase 2 data for the company's heart failure therapy showed statistically significant improvements across a number of measurements. 

By Lisa LaMotta • Aug. 29, 2016

Novartis scores a win in progressive MS

The experimental treatment, known as BAF312, is meant to be a successor to Novartis' approved MS therapy Gilenya, which will likely face generic competition.

By Lisa LaMotta • Aug. 25, 2016

BioCardia finds alternative funding solution

The California biotech is conducting a reverse merger to help fund a late-stage study. 

By Lisa LaMotta • Aug. 24, 2016

Tokai continues to unwind clinical program

The biotech ends another study after a Phase 3 failure showed its prostate cancer drug was ineffective.

By Lisa LaMotta • Aug. 23, 2016

Puma's neratinib closing in on EU market

European regulators accepted a filing for the biotech's breast cancer drug, despite known gastrointestinal issues caused by the drug. 

By Suzanne Elvidge • Aug. 23, 2016

Cerulean slashes staff after trial fails

The biotech will have only 23 employees after the layoffs, it announced. 

By Lisa LaMotta • Aug. 19, 2016

Nutrinia raises $30M for pediatric oral insulin

The biotech will use its latest injection of cash to focus on babies born with short bowel syndrome.  

By Nicole Gray • Aug. 19, 2016

Cerulean flunks another Phase 2 trial

The biotech reported a second clinical failure for its only drug, leaving it in dire straits as it tries to salvage the program. 

By Lisa LaMotta • Aug. 17, 2016

Indivior a step closer to US opioid market

The British biotech reports positive results for its opioid dependece treatment as concerns surge in the U.S. about opioid abuse. 

By Lisa LaMotta • Aug. 17, 2016

Boehringer seeks real-world data to support reversal agent

The pharmaceutical company is hoping to bolster sales of Pradaxa with real-wrold data supporting the use of its anti-coagulant reversal agent Praxabind. 

By Nicole Gray • Aug. 16, 2016

Bristol inks two combo deals after Opdivo miss

The cancer drug developer is making combination therapies a priority for its closely-watched Opdivo, which recently did not beat out chemotherapy in first-line treatment of lung cancer. 

By Lisa LaMotta • Aug. 16, 2016

Cynapsus proceeds after safety OK

Cynapsus hopes to introduce a sublingual version of apomorphine, which is used to treat the 'off' state in patients with Parkinson's disease. 

By Nicole Gray • Aug. 16, 2016

Vertex undeterred despite CF setback

The specialty pharma will continue to develop VX-661 plus ivacaftor in several cystic fibrosis populations after falling short in a high-risk patient group. 

By Lisa LaMotta • Aug. 16, 2016

OncoGenex scrambles after trial fail

A Phase 3 study of the small pharma's lead candidate failed to demonstrate a survival benefit in advanced prostate cancer. 

By Ned Pagliarulo • Aug. 16, 2016

Aurinia succeeds, but safety concerns loom

A high number of patient deaths in both treatment arms of the study overshadowed the positive efficacy findings, leading Aurinia stock to fall by more than half yesterday. 

By Nicole Gray , Ned Pagliarulo • Aug. 16, 2016

ICPE Booth A2 - ICON

Discover a convergence model driven by real-world intelligence and patient-centric innovation.

By Ramita Tandon, Executive Vice President
 Commercialisation & Outcomes, ICON plc • Aug. 16, 2016

AcelRx meets goal in Phase 3, but stock slips

The California biotech has partnered with the Department of Defense for development of its formulation of the powerful pain drug sufentanil. 

By Ned Pagliarulo • Aug. 15, 2016

Nymox readies FDA filing for prostate drug

Following strong Phase 3 results, Nymox plans to submit an application for approval sometime in the next three to six months. 

By Lisa LaMotta • Aug. 12, 2016

Spark Therapeutics on track to file gene therapy in 2017

The biotech reported positive results from a late-stage trial of its lead gene therapy candidate. 

By Nicole Gray • Aug. 11, 2016

NIH shuts down facility used to produce drugs for clinical trials

Inspections by the FDA last year revealed serious violations of proper manufacturing processes, prompting a sweeping review of all sterile production at the national medical research agency.

By Ned Pagliarulo • Aug. 10, 2016

Hopes of early end to Lilly breast cancer trial dashed

The big pharma's CDK 4/6 inhibitor will continue through its Phase 3 program as planned, but Lilly had hoped the trial would be stopped early.

By Lisa LaMotta • Aug. 10, 2016

AstraZeneca's lung cancer hopeful fails in Phase 3

Deevelopment of selumetinib for thyroid cancer and neurofibromatosis will continue, despite the setback. 

By Nicole Gray • Aug. 10, 2016