Rethinking trial protocols to advance patient-centricity

Trial designers seek insight into patient burden to help plan more effective, patient-first trials.

July 12, 2018

Aquinox cuts staff by 50% in wake of late-stage miss

The study failure, announced two weeks ago, led Aquinox to halt all further development for its sole clinical candidate rosiptor.

By Ned Pagliarulo • July 10, 2018

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

Celgene's blood drug scores again in Phase 3

Luspatercept now holds late-stage victories for both beta-thalassemia and myelodysplastic syndromes, and should hit regulators' desks next year.

By Jacob Bell • July 10, 2018

Cel-Sci aims to woo shareholders after CRO fight

Fresh off a win in an arbitration case with its CRO, Cel-Sci sought to renew shareholder confidence around its Phase 3 drug Multikine

By Suzanne Elvidge • July 10, 2018

KemPharm shoots for ADHD filling in 2019

The biotech said the study met its endpoint, and intends to file for approval in early 2019.

By Lisa LaMotta • July 9, 2018

Axovant parades new preclinical therapy, much to investor delight

A licensing deal with Benitec Biopharma provides Axovant a much-needed pipeline expansion, as well as underscores its interest in gene therapy.

By Jacob Bell • July 9, 2018

CTI cancer drug faces clouded future after study failure

A confirmatory study designed to substantiate Pixuvri's benefit in non-Hodgkin lymphoma fell short of its goal, sending shares in the drugmaker tumbling. 

By Ned Pagliarulo • July 9, 2018

Regulus lays off 60% of staff, halts development

After a clinical hold led the biotech to scrap its lead drug last year, the company is pausing development of other programs as it weighs a way forward. 

By Lisa LaMotta • July 6, 2018

Biogen Alzheimer's drug shows unexpected signs of promise

Positive secondary results for the anti-amyloid drug come six months after an initial failure led many to discount its chances.

By Ned Pagliarulo • July 6, 2018

Ignorance vs. bliss: How to build a content sharing strategy on a mobile app for a wide range of patient preferences

People who join clinical trials are information-seekers and want to take an active role in their health. But developing interesting and engaging content for them is not always easy.

July 5, 2018

After failure, Zynerba shifts gears to save cash

Following unfavorable results from a Phase 1 study, the company will focus on its other asset, in Fragile X and epilepsy.

By Lisa LaMotta • July 5, 2018

Abivax up on mixed HIV data

The French biotech released topline results from the second part of its mid-stage study in HIV. 

By Lisa LaMotta • July 3, 2018

Tecentriq extends streak with win in breast cancer trial

Roche claimed Tecentriq's success in IMpassion 130 as the first positive Phase 3 study of an immunotherapy in triple-negative breast cancer. An overall survival benefit, however, has yet to be established.

By Ned Pagliarulo • July 2, 2018

In FDA first, Dermira secures approval for excessive sweating drug

The OK offers some relief to Dermira, which saw its stock plummet earlier this year on the unexpected failure of a closely watched drug. 

By Suzanne Elvidge • July 2, 2018

Celgene gets key Phase 3 win with anemia drug

After a rough year, the big biotech finally got some good news. Celgene and partner Acceleron plan to file for approval in early 2019.

By Lisa LaMotta • June 29, 2018

Galapagos posts 'underwhelming' cystic fibrosis results, boosting Vertex

In a further blow, Galapagos' partner AbbVie decided to back out of development of another triple combination study, raising doubts about the smaller biotech's program.

By Ned Pagliarulo • June 29, 2018

DIA18: CRISPR, AI, blockchain and the future of drug development

BioPharma Dive sat down with DIA's Sudip Parikh to discuss key takeaways from this year's conference as well as major challenges still to tackle.

By Jacob Bell • June 28, 2018

Aquinox scraps bladder pain drug after Phase 3 failure

Shares plummeted nearly 85% after the biotech's only clinical candidate crashed out of late-stage testing.

By Suzanne Elvidge • June 28, 2018

Summit turns from DMD after trial miss

The biotech will discontinue development of ezutromid and switch gears to antibiotics. 

By Lisa LaMotta • June 27, 2018

Global Blood bets sickle cell drug success will convince FDA

Following initial positive Phase 3 results for voxelotor, the biotech hopes to submit the drug for an accelerated approval.

By Ned Pagliarulo • June 27, 2018

FDA to pub surrogate endpoints used in cancer drug approvals

It's part of a broader effort to reassess how the agency evaluates treatment benefit amid rapid clinical advances. But the approach is not without critics.

By Ned Pagliarulo • Updated June 26, 2018

Jardiance shows potential in type 1 diabetes, clearing Phase 3 tests

Already approved for the more common type 2 diabetes, the drug has become an important asset for Lilly and Boehringer.

By Ned Pagliarulo • June 26, 2018

Immunotherapy advances spur new look at cancer vaccines

Researchers have long been intrigued by the idea of a cancer vaccine, drawn in by hints of an immune role in cases of "spontaneous" remissions to cancer.  Now, the immunotherapy boom is opening up new areas of research.

By Ned Pagliarulo • June 25, 2018

Merrimack pancreatic drug fails, development halted

The oncology company, which saw its shares lose a third of their value Monday, is shifting focus to two earlier-stage assets, as well as its pre-clinical portfolio.

By Lisa LaMotta • June 25, 2018

Roche aims for first-mover edge in small cell lung cancer

A late-stage trial win from a Tecentriq and chemotherapy pairing could put the Swiss pharma ahead of rivals in the less common lung cancer type.

By Ned Pagliarulo • June 25, 2018