Xtandi results bolster Pfizer, Astellas in prostate cancer

Strong data in hormone-sensitive prostate cancer could help Pfizer and Astellas as they face a challenger in J&J's Erleada.

By Suzanne Elvidge • Feb. 12, 2019

Eylea's PANORAMA data give fuller view of efficacy in label expansion bid

Regeneron's blockbuster eye drug benefited certain patients with severe diabetic retinopathy, a market the big biotech is eager to break into.

By Jacob Bell • Feb. 11, 2019

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

UniQure update bolsters outlook for hemophilia B gene therapy

While data came from only three patients, treatment with uniQure's experimental gene therapy led to Factor IX activity levels high enough to reduce bleeding risk.

By Suzanne Elvidge • Feb. 11, 2019

Sangamo setback pulls down gene editing biotech peers

Disappointing data from an in vivo study of Sangamo's zinc finger nuclease tech spurred sell-offs in other makers of gene editing-based therapies.

By Ned Pagliarulo • Feb. 8, 2019

Sanofi turns R&D focus inward amid cuts to drug pipeline

Following an industry-wide trend, the French drugmaker has dropped 13 developments projects this year in a bid to boost productivity.

By Ned Pagliarulo • Feb. 7, 2019

Solid's early DMD data comes up short, sinking shares

Preliminary biopsy data showed underwhelming results from the first three patients dosed. Company execs plan to carry on with higher dosing levels.

By Andrew Dunn • Feb. 7, 2019

MacroGenics breast cancer drug tops Herceptin in late-stage trial

Shares in the biotech more than doubled in value Wednesday, as the positive results surprised Wall Street. 

By Kirsten Jensen • Feb. 6, 2019

Sanofi's multiple myeloma drug hits goal, setting up 2019 filing

The French pharma said its therapy extended progression-free survival as a third-line treatment for patients with the blood cancer. 

By Andrew Dunn • Feb. 5, 2019

Pharma is shuffling around jobs, but a skills gap threatens the process

Drugmakers have found difficulty luring employees who can work with the latest technologies away from the likes of Amazon and Google, for instance. 

By Jacob Bell • Feb. 4, 2019

Does Merck need more than Keytruda?

The cancer drug's meteoric rise is responsible for most of Merck's growth, but analysts aren't sure if that's such a good thing.

By Jacob Bell • Feb. 1, 2019

J&J's Erleada has big shoes to fill, and a tough competitor to boot

Positive data from the TITAN trial supports a label expansion for the prostate drug, which would be helpful as it competes with Pfizer's Xtandi.

By Jacob Bell • Jan. 31, 2019

Takeda's dengue vaccine meets goal in Phase 3 study

The pharma is building its case for the vaccine in the mosquito-borne disease, which is considered a top 10 threat to global health by the WHO. 

By Suzanne Elvidge • Jan. 30, 2019

Roche Alzheimer's setback puts Biogen in lonely spot

A decision to discontinue two Phase 3 studies of crenezumab leaves Biogen's aducanumab as the chief hope of anti-amyloid proponents.

By Ned Pagliarulo • Jan. 30, 2019

Biogen leaves analysts guessing on aducanumab

The biotech declined to share details on interim readouts for the Alzheimer's drug, but plans to start another late-stage study testing whether it can prevent or delay clinical onset of the disease.

By Jacob Bell • Jan. 29, 2019

Decentralized clinical trials: Are we ready to make the leap?

Is the biopharma industry ready to take the next step and fully implement the ultimate in patient-centricity: "decentralized,” or virtual, clinical trials that allow patients to participate while almost never visiting a clinical site?

Jan. 29, 2019

Alexion's follow-on to Soliris succeeds in late-stage trial

The positive data support a U.S. submission of ravulizumab in the first half of 2019 for a rare blood clotting disorder known as aHUS.

By Jacob Bell • Jan. 28, 2019

Advaxis hit with clinical hold for cervical cancer drug

The FDA flagged issues with Advaxis' chemistry, manufacturing and controls, handing the biotech another setback. 

By Suzanne Elvidge • Jan. 24, 2019

Opdivo questions hang over Bristol-Myers amid sales miss

The pharma wants to focus on the drug pipeline it gains by buying Celgene. But withdrawal of a key application for Opdivo has analysts wondering about the immunotherapy's future.

By Ned Pagliarulo • Jan. 24, 2019

Potential Restasis rival falls short in head-to-head study

While Aurinia Pharma believes it has a dry eye drug to take on Allergan's top-selling treatment, new clinical data shade that notion with some doubt.

By Andrew Dunn • Jan. 22, 2019

AbbVie, J&J's Imbruvica falls short in pancreatic cancer

Combining the top-selling drug with chemo failed to improve survival in a Phase 3 study, illustrating the challenges presented by the tough-to-treat tumor type. 

By Suzanne Elvidge • Jan. 22, 2019

Lilly suspends Lartruvo promotion after Phase 3 failure

A miss on overall survival in the pharma's ANNOUNCE study calls into question the cancer drug's earlier accelerated approval.

By Jacob Bell • Jan. 18, 2019

Aptinyx stung by pain drug's mid-stage miss

The biotech's shares fell roughly 70% Wednesday morning as investors questioned the outlook for its lead candidate.

By Jacob Bell • Jan. 16, 2019

FDA to bulk up cell and gene therapy staff, growing with the field

Two FDA leaders said the development of cell and gene therapies has reached  "a turning point," leading to new agency plans to keep pace with research.

By Andrew Dunn • Jan. 16, 2019

At JPM, the NASH flood gates start to crack

Multiple late-stage results are slated for 2019, bringing to the forefront a question of how battle lines will be drawn across the market.

By Jacob Bell • Jan. 11, 2019

Hunting productivity, drugmakers pitch new 'pillars' of R&D

By some measures, returns on R&D have fallen to decade lows. Pharmas and biotechs, however, argue new technologies could open faster paths to market. 

By Ned Pagliarulo • Jan. 11, 2019