After accelerated approval, Merck's Keytruda fails in liver cancer study

The negative results raise questions about Keytruda's earlier OK, which was based on findings from a smaller Phase 2 trial.

By Andrew Dunn • Feb. 20, 2019

Pfizer tweaks Xeljanz trial after embolism safety signal

An independent analysis raised concerns over the occurrence of pulmonary embolisms among patients receiving 10 mg of Xeljanz twice daily.

By Jacob Bell • Feb. 20, 2019

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

Pfizer, Lilly roll out more late-stage results for non-opioid pain drug

Yet safety questions on tanezumab and the anti-NGF class persist, making prospects for approval more uncertain even as the FDA encourages non-opoid pain drug development. 

By Andrew Dunn • Feb. 19, 2019

Intercept NASH drug succeeds in field's first positive Phase 3 trial

The results position Intercept to be first to market with a treatment for the fatty liver disease, now the target of substantial drugmaker investment.

By Ned Pagliarulo • Feb. 19, 2019

Hunt for immunotherapy combinations turns up success in kidney cancer

Drug pairings tested by Merck and Pfizer proved effective, and could soon compete with Bristol-Myers' combo in metastatic renal cell carcinoma. 

By Ned Pagliarulo • Feb. 16, 2019

New prostate cancer data puts Bayer drug in line with Pfizer, J&J rivals

Pfizer and J&J are already on the market with products for non-metastatic prostate cancer. Bayer aims to compete with its drug darolutamide.

By Andrew Dunn • Feb. 15, 2019

DBV sets sights on FDA resubmission for peanut allergy treatment

The biotech withdrew its application last December after the FDA asked for details on the company's manufacturing and quality control for Viaskin Peanut.

By Ned Pagliarulo • Feb. 14, 2019

Merck plans trio of Phase 3 Keytruda studies in prostate cancer

Announcement of the trials comes as the drugmaker unveiled mid-stage data from testing of several Keytruda combos in the common cancer type.

By Andrew Dunn • Feb. 14, 2019

J&J's esketamine wins backing of key advisory panel

Committee experts recommended the FDA approve the depression drug, giving cover for the agency to take a more flexible approach in its review.

By Ned Pagliarulo • Feb. 12, 2019

Merck kidney cancer data impresses, putting pressure on Bristol-Myers

Trial results showing a strong survival benefit for Merck's Keytruda in renal cancer could help the pharma make further gains on its immuno-oncology rival.

By Ned Pagliarulo • Feb. 12, 2019

Gilead's lead NASH drug not so STELLAR in first late-stage readout

While predicted by many, selonsertib's failure in STELLAR 4 further dims the drug's prospects as a treatment for the fatty liver disease.

By Jacob Bell • Feb. 12, 2019

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

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