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

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

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

Axovant buoyed by early gene therapy data

After a damaging Alzheimer's setback, Axovant has bet its future on gene therapy. Its programs in Parkinson's and Tay-Sachs are its most advanced.

By Jacob Bell • March 11, 2019

Roche wins first immunotherapy approval for triple-negative breast cancer

The FDA OK, however, is contingent on further study and is only for patients whose tumors express a biomarker called PD-L1.

By Ned Pagliarulo • March 8, 2019

AMAG pregnancy drug's future in doubt after key study miss

A confirmatory trial designed to support Makena's approval failed, likely crimping its commercial prospects. Yet the drug may still remain on market. 

By Jacob Bell • March 8, 2019

Allergan depression drug fails in setback for turnaround

Rapastinel, which Allergan once pegged for $1 billion to $2 billion in peak sales, missed its goal in three studies and looks set to fall short in a fourth.

By Ned Pagliarulo • March 7, 2019

Site score card: Expert tips for moving up the ranks

Former site director shares his tips for using metrics to move a study site to the top of a clinical research sponsor’s site list of high performers.

By Sean Walsh, MBA, ACHE • March 7, 2019

Second Vertex triple combo succeeds in cystic fibrosis, setting up crucial choice

The biotech plans to take one of its experimental regimens to the FDA later this year, but wants more data in hand before deciding on which one. 

By Suzanne Elvidge • March 6, 2019

Gilead scores key HIV data as Descovy proves non-inferior to Truvada

Positive results from the DISCOVER trial will support a filing to expand Descovy's use into PrEP, an indication that has been lucrative for Truvada.

By Jacob Bell • March 6, 2019

Alnylam's givosiran clears Phase 3 test in second RNAi win

The biotech plans to submit the drug, which treats a rare genetic disease, to regulators in the U.S. and Europe later this year. 

By Kristin Jensen • March 6, 2019

FDA approves J&J's esketamine as faster-acting depression treatment

Esketamine, chemically related to ketamine, is the first drug approved in decades that works differently from available antidepressants. Yet the OK comes with several strong warnings.

By Ned Pagliarulo • Updated March 6, 2019