AcelRx stock jumps after trial success

Positive results from a third and final Phase 3 trial of AcelRx's opioid painkiller clear the way for an NDA by the end of the year. 

By Ned Pagliarulo • Sept. 15, 2016

Roche bolsters evidence for MS drug Ocrevus

New post-hoc data showed Ocrevus helped better control relapsing MS better than Roche's Rebif, while also showing efficacy in primary progressive MS. 

By Ned Pagliarulo • Sept. 14, 2016

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

Foamix shares bubble up on Phase 2 data

A topical minocycline foam developed by the specialty pharma helped control rosacea symptoms. 

By Suzanne Elvidge • Sept. 14, 2016

PhRMA highlights industry's autoimmune drug pipeline

A new report from the industry association touts the 300+ drug pipeline, which could bring a wave of new meds to autoimmune disease patients.

By Suzanne Elvidge • Sept. 14, 2016

How to expedite FDA approvals of orphan drugs

A rare disease drug approval was pushed through with the support of PK models to inform dosing strategies.

Sept. 13, 2016

Aveo halts study of lung cancer drug

The Cambridge-based oncology company has struggled to shrug off other troubles tied to its lead candidate, settling fraud charges with the SEC in March. 

By Ned Pagliarulo • Sept. 12, 2016

AstraZeneca searches for differentiator in diabetes market

The big pharma begins multiple outcomes studies for its type 2 diabetes drug. 

By Lisa LaMotta • Sept. 12, 2016

Lexicon, Sanofi tout positive T1 diabetes data

The pair announced strong results in Phase 3 for an SGLT2 inhibitor in type 1 diabetes patients. 

By Lisa LaMotta • Sept. 9, 2016

J&J pushes forward with hep C triple-combo

Interim results released Friday by J&J partner Achillion showed promise for treating the liver disease in a shorter time period than existing options.

By Ned Pagliarulo • Sept. 9, 2016

Repros climbs on Phase 2 data

Results from an ongoing trial showed Repros' endometriosis drug cut pain pill use by half in women with moderate to severe endometriosis. 

By Suzanne Elvidge • Sept. 8, 2016

Bluebird proceeds with late-stage trial after key improvement

Shares of Bluebird moved higher on news the Cambridge-based biotech would be able to proceed with an improved manufacturing process in its Phase 3 trial. 

By Ned Pagliarulo • Sept. 8, 2016

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

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