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

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

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

Lilly strengthens Trulicity's leading position with REWIND results

Wall Street analysts note data from the cardiovascular outcomes study could help differentiate the diabetes drug in the crowded GLP-1 market.

By Jacob Bell • Nov. 5, 2018

Alkermes depression drug approval odds slim after negative FDA panel vote

An agency advisory panel voted 21-2 against recommending approval for ALKS-5461, sending shares in the company sliding. 

By Ned Pagliarulo • Nov. 2, 2018

GSK's once-monthly HIV therapy shows promise, hitting goal

Positive Phase 3 results lend further support to the long-acting therapy, part of the British drugmaker's push to reinvigorate its HIV business.

By Suzanne Elvidge • Oct. 31, 2018

Roche touts eye drug pipeline progress

Swiss rival Novartis, however, is advancing its own experimental eye drug that it hopes can compete in the market for macular degeneration therapies. 

By Suzanne Elvidge • Oct. 30, 2018

Shares slump as Ultragenyx drops rare disease study

Missed endpoints in a Phase 3 study mean Ultragenyx will halt some research with UX007, one of three experimental drugs in the biotech's pipeline.

By Suzanne Elvidge • Oct. 29, 2018

How can pharma foster patient habits that will have an impact on your brand?

While there is a place for incorporating external motivators to influence behavior, behavioral science tells us that this is only part of the solution.

By Neala Havener Senior Behaviorist MicroMass Communications Inc. • Oct. 29, 2018

Esperion clears final trial hurdle in bid to shake up cholesterol market

Investors have awaited results from a fifth study of bempedoic acid to judge whether Esperion might outflank pricey PCSK9 inhibitors.

By Ned Pagliarulo • Oct. 28, 2018

FDA hits Regeneron with CRL for Eylea syringe

The biotech still expects, however, to launch the pre-filled syringe version of its blockbuster eye drug sometime next year.   

By Suzanne Elvidge • Oct. 26, 2018

Biogen dips as BAN2401 data bring more questions than answers

Whether BAN2401 is an effective drug for treating early Alzheimer's remains as divisive a question as before, despite updated results from Biogen and Eisai.

By Ned Pagliarulo , Jacob Bell • Oct. 25, 2018

Pfizer, Lilly avoid safety red flags in late-stage tanezumab trial

A key test, however, will come next year, when the companies report data from a large long-term safety study.

By Ned Pagliarulo • Oct. 24, 2018

How embracing flexibility creates success for all

When your internal processes aren't meeting the needs of your clients, considering new methods can go a long way.

Oct. 24, 2018