Reata stock surges on positive data in CKD patients

The results could mean a quicker route to approval for bardoxolone methyl in a rare form of chronic kidney disease.

By Suzanne Elvidge • July 24, 2018

Tecentriq misses another chance to catch Keytruda

In initial looks at two Phase 3 studies this year, Roche's immunotherapy has fallen short of the bar set by Merck's rival drug. 

By Ned Pagliarulo • July 19, 2018

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

Allergan's eye drug stacks up against Lucentis, but wider market still iffy

Late-stage tests showed abicipar was non-inferior to Roche's blockbuster. But greater inflammation suggests Allergan has more work to prove the drug's marketability.

By Jacob Bell • July 19, 2018

Pfizer, Lilly tout positive tanezumab data, but safety questions remain

Trial results showed the non-opioid pain drug improved physical function. But details on safety, a key issue for NGF inhibitors like tanezumab, were limited.

By Lisa LaMotta • July 18, 2018

Invokana renal trial stopped early for efficacy

A late-stage outcomes study could help reverse the fortunes of the multinational's aging diabetes medicine.

By Lisa LaMotta • July 17, 2018

Roche experimental flu drug clears second Phase 3

The Swiss pharma has already submitted the antiviral for U.S. approval, with a decision expected by late December. 

By Ned Pagliarulo • July 17, 2018

CytoDyn touts new data in drug-resistant HIV patients

Even amid an acquisition and new interest in cancer, HIV is still the main focus for CytoDyn and its lead candidate.

By Suzanne Elvidge • July 17, 2018

Cassiopea prospects fill in as hair loss drug shows promise

The small biotech believes these results, while preliminary, show efficacy to compete with Propecia.

By Ned Pagliarulo • July 16, 2018

Dermavant finds 'cornerstone' drug in GSK's pipeline

The British pharma will out-license tapinarof, in testing for psoriasis and atopic dermatitis, to Dermavant for nearly $200 million.

By Ned Pagliarulo • July 12, 2018

New epilepsy data sets Zogenix up for showdown with GW

More late-stage data showed patients with a rare form of epilepsy had greater reductions in monthly seizures when taking ZX008 compared to placebo.

By Jacob Bell • July 12, 2018

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

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