Drug development innovations that work: Adaptive trial design

Adaptive trials can increase the potential of a drug launch by 13%. So why is this method still underutilized by the industry?

Nov. 27, 2018

Could Gilead and Galapagos' JAK inhibitor lead the class? Wall Street thinks it has a chance.

The therapy lags its competitors in getting to market, but clinical data could make filgotinib stand out. How much would a late arrival hurt its prospects?

By Andrew Dunn • Nov. 26, 2018

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

5 rheumatologists discuss the evolving landscape of RA treatment

Drug pricing, JAK inhibitors and more personalized therapies are top of mind for many rheumatoid arthritis doctors.

By Jacob Bell • Nov. 26, 2018

Vectura asthma drug fails in Phase 3 study

As a result, the pharma will abandon VR475 but carry on with another candidate and three early-stage nebulization programs.

By Andrew Dunn • Nov. 26, 2018

ASH data helps cement Darzalex's place in multiple myeloma standard of care

Adding the J&J drug to Revlimid and dexamethasone cut risk of death or cancer progression 45% for newly diagnosed patients ineligible for transplants.

By Jacob Bell • Nov. 21, 2018

Sobi's late-breaking ASH data also spurs an approval

Emapalumab, to be branded as Gamifant, is now OK'd in the U.S. for patients with a rare inflammatory disease known as primary HLH.

By Jacob Bell • Nov. 20, 2018

FDA's Woodcock: 'The clinical trial system is broken'

The CDER director said the current system doesn't serve the interests of patients and noted support for trials capable of answering multiple clinical questions at once. 

By Andrew Dunn • Nov. 20, 2018

Bavencio falls short in ovarian cancer study

The setback is the third miss for Pfizer and Merck KGaA's checkpoint inhibitor, which is being tested in three other late-stage studies of the tumor type.

By Suzanne Elvidge • Nov. 20, 2018

Aimmune's peanut allergy drug draws mixed reactions

Publication in NEJM of the PALISADE data reinforced analysts' confidence in AR101, but also may have stoked some safety concerns among investors.

By Jacob Bell • Nov. 19, 2018

MYSTIC deals another blow to AstraZeneca as Imfinzi misses on OS

Analysts said "statistical issues" could be behind Imfinzi monotherapy not delivering on overall survival in the first-line non-small cell lung cancer setting.

By Jacob Bell • Nov. 16, 2018

Blueprint posts 'impressive' data for lead candidate, but investor response tepid

One Wall Street analyst said Blueprint's lead drug candidate is shaping up to have a best-in-class profile after reviewing fresh clinical trial results.

By Suzanne Elvidge • Nov. 16, 2018

3 hemophilia patients lift uniQure's value more than $450M

After six weeks, hemophilia B patients who received the biotech's gene therapy had Factor IX levels thought to significantly reduce the risk of bleeding events.

By Jacob Bell • Nov. 15, 2018

A look at risk-based monitoring, 12 months later

The implementation of risk-based monitoring is moving forward, but it is not without its challenges.

By Kirill Soldatov, Director of Process Improvement • Nov. 15, 2018

Solid's manufacturing work allows trial to restart

After a challenging year, it looks as though Solid Biosciences' gene therapy for Duchenne muscular dystrophy is back on track.

By Suzanne Elvidge • Nov. 14, 2018

AbbVie showcases Mavyret's curative power with shorter regimen

The aim of EXPEDITION-8, a Phase 3b study, was to see if 8-week dosing would work in treatment-naive hep C patients with compensated cirrhosis.

By Suzanne Elvidge • Nov. 14, 2018

'Super'-responder analysis gives more power to Viking's fatty liver drug

VK2809 reduced liver fat content by 50% or more in 67% of patients, the analysis found, further supporting Viking's view that its drug could help with both NAFLD and NASH.

By Kristin Jensen • Nov. 13, 2018

Ionis, Akcea succeed in heart drug trial, setting up Novartis decision

The Phase 2 trial achieved all primary and secondary endpoints, helping lower lipoprotein(a) levels with a solid safety profile. Now, Novartis can choose to lead a Phase 3 trial or back out.

By Andrew Dunn • Nov. 13, 2018

Novartis' Entresto offers superior benefit to enalapril in heart study

Results from the PIONEER-HF trial reinforce the Swiss pharma's confidence that its drug can be a foundational therapy for certain heart failure patients.

By Suzanne Elvidge • Nov. 13, 2018

AstraZeneca calls victory in CV study, but will payers feel the same?

A large cardiovascular study found the British pharma's Farxiga offers heart health benefits, yet the diabetes drug still faces stiff competition.

By Jacob Bell • Nov. 12, 2018

Amarin's Vascepa trial stirs data debate as stock drops 10%

A five-year clinical trial showed strong heart benefits for the fish oil-based pill, but questions on the placebo used in the study have raised doubts as well.

By Andrew Dunn • Nov. 12, 2018

At SITC, clear wins for immunotherapy combos remain elusive

Findings presented over the weekend illustrate the challenge drugmakers face in their quest to improve on the success of Keytruda and Opdivo.

By Ned Pagliarulo • Nov. 12, 2018

NASH drugs come into focus as field awaits late-stage data

A second wave of NASH-focused biotechs has emerged behind the four drugmakers currently out in front. Next year will prove a major test.

By Ned Pagliarulo • Nov. 9, 2018

Gilead's search for the next great liver drug won't end with its FXR agonist

GS-9674 scored in clinical trials across multiple indications, but the drug is having difficulty standing out against rival therapies.

By Jacob Bell • Nov. 9, 2018

Mallinckrodt's rare disease drug set back by confusing trial result

Study results were supposed to show the drugmaker's treatment slowed disease progression more than placebo. Instead, both active and placebo groups showed no disease progression.

By Suzanne Elvidge • Nov. 8, 2018

Nektar lures Pfizer with promise of combo immunotherapy

A new research collaboration suggests the big pharma sees potential for Nektar's drug to boost response rates to immunotherapy. The jury on NKTR-214 is still out, however. 

By Ned Pagliarulo • Nov. 6, 2018