Tonix shelves fibromyalgia plans after Phase 3 miss

While the fibromyalgia program will be discontinued, Tonix hopes to move ahead with clinical development of TNX-102 in PTSD. 

By Ned Pagliarulo • Sept. 7, 2016

CoLucid gets boost from Phase 3 migraine results

The Cambridge, MA-based biopharma hopes its drug can be an effective treatment option for patients with cardiovascular risk factors. 

By Suzanne Elvidge • Sept. 7, 2016

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

AstraZeneca makes a play for asthma market with positive data

Benralizumab could cut hospitalizations with every-other-month dosing and make the big pharma competitive in the space. 

By Suzanne Elvidge • Sept. 6, 2016

Merck ditches long-troubled bone drug

The big pharma has finally scrapped development of its beleaguered osteoporosis drug after several years of delays. 

By Lisa LaMotta • Sept. 2, 2016

Momenta pulls the plug on pancreatic cancer drug

Enrollment in a Phase 2 trial testing necuparanib was halted earlier this month. Now the biotech is discontinuing the program altogether. 

By Ned Pagliarulo • Sept. 2, 2016

MedCo holds out for full analysis of cholesterol data

Medicine Company’s cholesterol drug interim data was 'inconclusive' and the company is waiting on the final trial results. 

By Suzanne Elvidge • Sept. 1, 2016

Roche's Tecentriq ready to compete in lung cancer

But stiff competition looms: Bristol-Myers' Opdivo and Merck's Keytruda have already staked out a significant lead in the red-hot immuno-oncology market. 

By Ned Pagliarulo • Sept. 1, 2016

Tonix preps to enter PTSD market

The biotech cleared Phase 2 and is readying its lead compound for late-stage trials.

By Lisa LaMotta • Aug. 31, 2016

CTI gets mixed data, but hold stands

Shares of the Seattle-based biotech jumped on the news, but development is still shadowed by a full clinical hold placed on the drug by the FDA in February. 

By Lisa LaMotta • Aug. 30, 2016

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

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