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

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

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

Aducanumab's failure puts pressure on field to look beyond amyloid

"At this point, we've done the right experiment and the hypothesis didn't hold true," said Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation.

By Ned Pagliarulo • March 22, 2019

Optimizing protocol design and enhancing patient enrollment

Using their extensive proprietary data sources, Covance guided an emerging pharmaceutical company who was uncertain about how to balance the selection of the right patients for their trial endpoints with the ability to achieve rapid patient recruiting.

March 22, 2019

Merck, NGM Bio extend research deal through 2022

Tucked in that announcement, however, was news Merck has handed back to NGM rights to two candidates for the treatment of obesity.

By Suzanne Elvidge • March 21, 2019

Biogen halts Alzheimer's drug trials in major setback for biotech

Aducanumab, which targets beta-amyloid, was considered one of the most advanced therapies in clinical testing for the neurodegenerative disease, making its failure a blow to research efforts. 

By Jacob Bell • Updated March 21, 2019

FDA issues partial hold on studies of AbbVie, Roche drug in multiple myeloma

A higher proportion of deaths were observed in the treatment arm versus control group of a study testing Venclexta in the blood cancer.

By Suzanne Elvidge • March 20, 2019

Pfizer, Merck KGaA miss again in ovarian cancer

Bavencio, the companies' PD-L1 antibody, has fallen short in three ovarian cancer trials, adding to its struggles to make gains in the immuno-oncology market.

By Andrew Dunn • March 20, 2019

Roche's Tecentriq secures another immunotherapy first

The drug is the first immunotherapy approved for first-line small cell lung cancer, and the first new initial treatment option for the cancer type in decades.

By Ned Pagliarulo • March 19, 2019

Heart benefits to AstraZeneca's Farxiga detailed in new findings

While the SGLT-2 inhibitor showed a heart benefit across a wide range of Type 2 diabetes patients, the effect appeared greatest in those with reduced ejection fraction.

By Ned Pagliarulo • March 18, 2019

Amarin's Vascepa shows 30% CV risk reduction in new analysis

The fish oil-derived pill reduced total cardiovascular events by a wide margin against placebo, but the new look does little to answer lingering questions.

By Andrew Dunn • March 18, 2019

Dermira shares double on positive eczema data

The dermatology-focused biotech is now mulling a late-stage trial that would test two higher-dose regimens of its drug, lebrikizumab.

By Jacob Bell • March 18, 2019

Apple heart study: Early proof of concept, or a bit of a gimmick?

Cardiologists at the ACC meeting said the Apple Watch's foray into health monitoring needs more data to prove its value.

By David Lim • March 16, 2019

Amgen not done in quest to prove Repatha

A study set to begin in June will assess the cholesterol drug in patients who are at high risk of — but have not yet had — cardiovascular events like stroke.

By Jacob Bell • March 15, 2019

Lilly's Cyramza comes up positive in first-line lung cancer trial

A late-stage study of certain lung cancer patients found significantly longer progression-free survival for those who received Cyramza versus those who didn't.

By Suzanne Elvidge • March 13, 2019

Celgene's Abraxane fails late-stage pancreatic cancer study

A pivotal Phase 3 trial showed the drug combined with chemotherapy did not improve disease-free survival as an adjuvant treatment.

By Andrew Dunn • March 13, 2019

Why virtualize clinical trials?

Virtual clinical trials eliminate many obstacles presented by the standard model of clinical trials and bring benefits for sponsoring companies, investigators, and patients themselves. 

March 12, 2019

Takeda's Entyvio beats AbbVie's Humira in head-to-head UC study

The Phase 3b trial found ulcerative colitis patients had more clinical responses when using Takeda's biologic rather than the world's top-selling drug. 

By Andrew Dunn • March 11, 2019