Gilead and Novo Nordisk pair up to take on NASH

Combinations are seen as the best way to combat the disorder, which is believed to be growing in prevalence thanks to rising obesity rates.

By Jonathan Gardner • April 12, 2019

Wave delays key data readout for Huntington's therapy

Screening and administration challenges are pushing back expected readouts as much as six months, helping to reaffirm Roche and Ionis' leading position.

By Jacob Bell • April 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

Intercept sputters as it reveals full Ocaliva NASH data to doctors

Side effects and a competitive threat from Gilead derailed what should have been a good day for Intercept. 

By Jonathan Gardner • April 11, 2019

Alkermes touts Aristada efficacy on-par with J&J's market leader

Aristada and Invega Sustenna showed similar efficacy in a six-month study evaluating them as treatments for acute exacerbation of schizophrenia.

By Suzanne Elvidge • April 10, 2019

Unblinded: Hervé​ Hoppenot on solving Incyte's 'single asset syndrome'

Last April, a closely watched study of an Incyte cancer drug failed, sending the biotech back to the drawing board. This year could help answer what's next. 

By Ned Pagliarulo • April 10, 2019

Audentes lays down marker in muscular dystrophy

In a challenge to Sarepta, Solid and Pfizer, a new gene therapy approach aims to deliver a more functional muscle-repairing protein to DMD patients.

By Jonathan Gardner • April 8, 2019

United Therapeutics scraps drug after late-stage miss

A failed trial has pushed the drugmaker to halt development of esuberaprost, which execs thought could expand the market opportunities for Tyvaso.

By Jacob Bell • April 8, 2019

No return for the Merrimack

The cancer drugmaker is shelving another lead candidate and shaving down its workforce — the latest in a year of setbacks.

By Jacob Bell • April 5, 2019

Pfizer wins expanded Ibrance approval using real world data

Relying on EHRs and real-world use of the cancer drug, the FDA broadened Ibrance's label to include men with certain advanced breast cancers. 

By Ned Pagliarulo • April 5, 2019

Allergan eye drug fails to impress on safety, upping pressure ahead of key meeting

Analysts were skeptical of the new data on abicipar, giving investors new reasons to question Allergan's pipeline before a May 1 annual meeting.

By Andrew Dunn • April 3, 2019

Astellas' AML therapy bests chemo in Phase 3 study

Confirmatory results from the trial back up Xospata's accelerated approval from the FDA last November. 

By Emily Mullin • April 2, 2019

Early pancreatic cancer data give Clovis a new path in PARP market

Yet pharma rival AstraZeneca remains ahead, having posted positive Phase 3 data in pancreatic cancer earlier this year.

By Andrew Dunn • April 2, 2019

Sangamo hemophilia A progress boosts shares

Early data suggest Sangamo's gene replacement therapy could restore near-normal levels of a needed clotting factor. Competitors in the space still maintain a sizable lead, however. 

By Ned Pagliarulo • April 2, 2019

Despite research boom, few immunotherapy studies targeting pancreatic cancer

Investment in immunotherapy research is surging, yet studies testing new drugs for the hard-to-treat tumor type are relatively less common.

By Ned Pagliarulo • April 1, 2019

Early studies hint at some potential for CAR-T therapy in solid tumors

While the cell treatments have proved a breakthrough in treating certain blood cancers, research efforts to replicate that success in solid tumors have so far fallen short. 

By Ned Pagliarulo • March 31, 2019

AstraZeneca finds early-stage success with MET inhibitor in lung cancer

The Phase 1b study showed the potential of a new treatment path for a particularly difficult-to-treat lung cancer type.

By Andrew Dunn • March 31, 2019

AstraZeneca inks ambitious $6.9B deal for Daiichi cancer therapy

The deal gives the British pharma access to an antibody-drug conjugate that the companies view as a challenger to several on-market cancer drugs. 

By Ned Pagliarulo • March 29, 2019

Gilead earns needed trial win as arthritis drug succeeds in 2 studies

Filgotinib, a JAK inhibitor that Gilead's bet heavily on, met the goals of two large Phase 3 trials. But its road through the FDA remains uncertain.

By Ned Pagliarulo • March 28, 2019

Seattle Genetics bladder cancer drug succeeds in Phase 2 trial

The biotech, along with partner Astellas, plans to submit an application for approval of the drug later this year. 

By Kristin Jensen • March 28, 2019

Sarepta to seek speedy approval of third DMD drug

Interim muscle biopsy data could support a mid-year filing of casimersen, which works in a similar fashion to Sarepta's approved drug Exondys 51.

By Ned Pagliarulo • March 28, 2019

Pfizer squeezes out positive data for fructose-fighting NASH drug

The Phase 2 findings, however, come with several questions, not least of which is how the drug works.

By Jacob Bell • March 28, 2019

Jazz's narcolepsy treatment passes Phase 3 test

Analysts at Cowen & Co. view the drug, dubbed JZP-258, as a potential successor to the company's blockbuster franchise Xyrem.

By Kristin Jensen • March 27, 2019

Aimmune's peanut drug moves closer to European market

AR101 hit the primary endpoint of a Phase 3 European study, results Aimmune intends to include in a mid-year submission to the EMA.

By Suzanne Elvidge • March 26, 2019

Conatus drug misses goal, hitting NASH stocks

A Phase 2b study showed Conatus' emricasan failed to beat out placebo in NASH fibrosis, sending other biotechs in the space into the red on Friday. 

By Emily Mullin • March 22, 2019

Pharmacquired: Biogen could use a big deal. Too bad it doesn't do those

Failure of aducanumab puts Biogen in a tight spot. A major buy could help, but finding the right target will be a challenge.

By Jacob Bell • March 22, 2019