Clinical Trials

Column
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
Deep Dive
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
Deep Dive
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
Column
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
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
Deep Dive
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 09, 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 09, 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 06, 2018
Conatus shares slide on emricasan study failure

The focus now turns to three trials Conatus is conducting with Novartis to test the experimental liver disease drug to treat NASH.

By Randi Hernandez • April 05, 2018
Boehringer joins checkpoint inhibitor race with OSE deal

In a heavily back-ended agreement, Boehringer is betting on a second wave of I/O drug development through the exploration of targets other than PD-1/L1.

By Ned Pagliarulo • April 05, 2018
Lilly's Cyramza succeeds in Phase 3 liver cancer study

Cyramza is one of a handful of new drugs Lilly is counting on to fuel growth.

By Suzanne Elvidge • April 05, 2018
Benefit of GenSight's gene therapy not so clear

Patients received GenSight’s candidate in one eye and a sham treatment in the other. Yet visual acuity in both eyes appeared to improve, puzzling investigators.

By Randi Hernandez • April 04, 2018