Prothena pulls Phase 3 drug, stock plummets

The Irish biotech scrapped its amyloidosis candidate after a late-stage futility analysis returned disappointing results.

By Suzanne Elvidge • April 24, 2018

Novartis bolsters case for siponimod with new data

The results support Novartis' filing of the drug, which the pharma hopes will secure FDA approval for secondary progressive MS.

By Suzanne Elvidge • April 23, 2018

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

Merck antibiotic data positive in Phase 3

The promising data moves the pharma closer to a submission to the FDA.

By Suzanne Elvidge • April 23, 2018

Prescribed Reading: Shire on the block; FDA flip-flops

There are potentially multiple suitors looking to take out Shire. Elsewhere, the FDA is making surprise reversals.

By Lisa LaMotta • April 20, 2018

Tagrisso wins first-line lung cancer approval, boosting AstraZeneca

Securing the FDA OK is a key step in AstraZeneca's plan to turn Tagrisso into a multi-billion dollar drug franchise.

By Suzanne Elvidge • April 20, 2018

FDA seeks info on DMD drug as hold remains

Solid Biosciences said it will respond within weeks to the latest agency questions regarding its experimental gene therapy.

By Suzanne Elvidge • April 19, 2018

ImmuPharma dives on late-stage lupus failure

A high placebo response threatens to squash interest from larger pharma companies in the U.K. biotech's drug, Lupuzor.

By Jacob Bell • April 18, 2018

Celldex cancer drug crashes out at Phase 2b

The biotech will ditch further development after the drug failed to meet its primary endpoint in a triple-negative breast cancer study.

By Suzanne Elvidge • April 17, 2018

Merck looks to catch Bristol with new melanoma data for Keytruda

In one of several successes for Keytruda at AACR, the immunotherapy helped reduce the risk of melanoma recurring following surgery. 

By Randi Hernandez • April 16, 2018

Two years after cancer setback, Bristol-Myers' new biomarker bet pays off

The success of CheckMate-227 is a step toward validating tumor mutational burden, but questions remain about how easily the test could be adopted.

By Ned Pagliarulo • April 16, 2018

I/O combos inch forward in pharma's lung cancer quest

An impressive survival benefit could lift Merck's Keytruda plus chemo regimen, while Bristol-Myers hopes its checkpoint inhibitor pairing can help it catch up. 

By Ned Pagliarulo • April 16, 2018

NGM Bio hits endpoint in Phase 2 NASH study

The biotech's engineered hormone drug rapidly reduced liver fat and fibrosis in patients with liver disease. The next step will be a Phase 2b study in NASH patients later this year.

By Suzanne Elvidge • April 16, 2018

FDA removes clinical hold on Bellicum's cell therapy

Bellicum's trials for BPX-501, which are investigating the candidate as an adjunctive therapy for stem cell transplantation in cancer, may now resume after the FDA OK’d protocol modifications.

By Randi Hernandez • April 13, 2018

Prescribed Reading: Novartis ups the ante in gene therapy, while GSK folds on the space

Big pharmas are placing their bets on the future of gene therapy, with one European company going all-in and another pulling out.

By Lisa LaMotta • April 13, 2018

The power of AI in transforming clinical trials

Artificial intelligence, combined with automatically collected big data, holds the potential to solve many key clinical trial challenges.

April 12, 2018

Roche pauses Tecentriq/Cotellic cancer trial after 4 patient deaths

The Swiss pharma called a temporary halt to recruitment in its PD-L1/MEK inhibitor Phase 2 study for metastatic colorectal cancer.

By Suzanne Elvidge • April 12, 2018

Gene therapy heavyweights talk next steps for CAR-T

Several big names in cell and gene therapy development discussed what's on the horizon at a meeting of the Alliance for Cancer Gene Therapy.

By Lisa LaMotta • April 11, 2018

Pfizer's Inlyta misses mark in Phase 3 kidney cancer study

Attention will now turn to a combination study testing the tyrosine kinase inhibitor together with Pfizer's immunotherapy Bavencio.

By Ned Pagliarulo • April 11, 2018

Kadmon gets FDA go-ahead for ROCK2 inhibitor study

​Based on the regulator's feedback, Kadmon says a planned Phase 2 open-label study could potentially support registration of the drug in graft-versus-host disease.

By Suzanne Elvidge • April 11, 2018

Menlo's Phase 2 skin data disappoints, shares plummet

Though it could not scratch the Phase 2 itch, the company is still banking on the NK-1 receptor agonist's potential in other indications. 

By Randi Hernandez • April 10, 2018

Latest Phase 3 failure underscores Alzheimer's indomitable nature

Shares of vTv Therapeutics fell nearly 70% on the news it is discontinuing clinical studies of its lead candidate following a late-stage miss.

By Jacob Bell • April 10, 2018

AstraZeneca snaps up NASH candidate from Ionis

The British pharma will pay Ionis $30 million to take over development reins, the third time it has licensed a drug from Ionis under a 2015 deal. 

By Suzanne Elvidge • April 10, 2018

With study success, AbbVie's arthritis hopeful looks to be a safer bet

Upadacitinib hit on all trial endpoints in a large Phase 3 study, results that eased concerns about the experimental JAK inhibitor's safety profile.

By Ned Pagliarulo • April 9, 2018

Keytruda shows OS benefit across broader range of lung cancer patients

Merck's drug improved overall survival in NSCLC patients with PD-L1 levels at or greater than 1%, according to an interim analysis.

By Jacob Bell • April 9, 2018

Incyte cancer study fails, setting back drug combo hopes

Dealing a major blow to Incyte, epacadostat failed to perform as expected in a closely watched study pairing the IDO inhibitor with Merck's Keytruda.

By Ned Pagliarulo • April 6, 2018