J&J's psoriasis drug trumps Humira in Phase 3

Janssen is testing its IL-23 inhibitor guselkumab in two other Phase 3 studies, hoping to build on the success of Stelara and the rest of its psoriasis portfolio. 

By Suzanne Elvidge • Oct. 3, 2016

Alnylam shifts gears after safety issues

Alnylam said Thursday it halted continuation of proposed liver disease drug RNAi based on safety concerns in a Phase 1-2 study, and will pursue regulatory approval for another therapy. 

By Joe Cantlupe • Sept. 30, 2016

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

UPDATED: BI plays hot potato with Hanmi, returns cancer drug

The German drugmaker abruptly abandoned a mid-stage lung cancer drug after reports surfaced about patient deaths. 

By Lisa LaMotta • Sept. 30, 2016

Regeneron slips on trial setback for Eylea combo

Pairing Eylea with an experimental antibody led to poorer safety and efficacy data in wet AMD patients than treatment with Eylea alone.  

By Ned Pagliarulo • Sept. 30, 2016

FDA halts trial of Alcobra's ADHD drug

Alcobra said the FDA verbally issued a full clinical hold due to concerns over preclinical neurological data. 

By Suzanne Elvidge • Sept. 30, 2016

Catabasis hopes to ride Sarepta approval wave

Several weeks after winning approval for eteplirsen, the Cambridge-based company is teaming up with another biotech down the street to test a combo therapy in DMD.

By Lisa LaMotta • Sept. 29, 2016

Intra-Cellular slammed by late-stage failure

The New York-based biotech lost over 60% of its value after its schizophrenia drug failed to perform better than a placebo in a Phase 3 trial. 

By Lisa LaMotta • Sept. 29, 2016

Novartis, Amgen score Phase 3 win for migraine drug

The drugmakers are testing the CGRP inhibitor in both chronic and episodic migraine, racing to beat several other companies with similar drugs to market. 

By Ned Pagliarulo • Sept. 29, 2016

Incyte pads positive early data for cancer combo

SImilar to the strategy of other biotechs, Incyte hopes to boost the efficacy of its own cancer drug by pairing it with Merck's Keytruda. 

By Suzanne Elvidge • Sept. 29, 2016

FDA hits pause on CEL-SCI Phase 3 trial

Few details were provided about a clinical hold for the company's only clinical-stage product. 

By Jacob Bell • Sept. 28, 2016

Galectin plunges after miss in exploratory NASH trial

Shares in the biotech nearly halved in value Wednesday, as investors soured on the potential of Galectin's lead drug after it failed to hit its goal in a Phase 2a study. 

By Joe Cantlupe • Sept. 28, 2016

Boehringer gets option to buy in I/O deal

Austria-based ViraTherapeutics, which received venture funding from Boehringer, will lead preclinical and Phase 1 testing of its lead oncolytic virus therapy. 

By Ned Pagliarulo • Sept. 28, 2016

Amgen's Kyprolis fails in first-line myeloma

Poor results from a late-stage trial may hinder Amgen's ability to grow market share.

By Lisa LaMotta • Sept. 27, 2016

Mast cuts back after Phase 3 miss

The San Diego-based company plans to search for potential partners to continue development of its remaining clinical-stage candidate. 

By Suzanne Elvidge • Sept. 27, 2016

Kite bolsters lead with positive CAR-T data

Interim results from the ZUMA-1 study met the primary endpoint, although some questions remain on the durability of the responses to treatment. 

By Ned Pagliarulo • Sept. 27, 2016

GW Pharma's Epidiolex hits mark for rare type of epilepsy

With positive results in hand from 2 other Phase 3 trials studying the cannabidiol drug, GW Pharma plans to apply for U.S. approval next year. 

By Suzanne Elvidge • Sept. 27, 2016

Novartis eyes showdown with Roche as cancer drug hits goal

The Swiss rivals are both chasing Pfizer's Xalkori, the standard option for first-line treatment of ALK+ non-small cell lung cancer.

By Joe Cantlupe • Sept. 26, 2016

AbbVie sees high marks in hep C study

Competition in the hepatitis C market has grown, as drugmakers seek to steal market share from Gilead's top-selling drugs Sovaldi and Harvoni. 

By Joe Cantlupe • Sept. 26, 2016

J&J firms up efficacy data on hep C triple combo

Updated results showed the cocktail of three drugs led to sustained viral responses 12 weeks after treatment in 100% of patients receiving the combo. 

By Suzanne Elvidge • Sept. 26, 2016

Lundbeck failure in Alzheimer's reverberates

The company's drug idalopirdine missed the mark in a Phase 3 study, a setback that could have repercussions for other drugs in the AD pipeline. 

By Suzanne Elvidge • Sept. 23, 2016

Gilead shutters study for anti-MMP9 drug

Although the experimental drug failed a Phase 2/3 trial in ulcerative colitis, Gilead intends to push on with other studies testing the drug in various indications. 

By Ned Pagliarulo • Sept. 22, 2016

Novartis continues data push for Entresto

Sales of the new heart failure drug have been slow to take off. But that hasn't stopped Novartis from ramping up its clinical development program.

By Suzanne Elvidge • Sept. 21, 2016

Amgen adds data for Repatha to boost profile

Hoping to improve uptake of its slow-moving drug, Amgen releases Repatha data showing changes to the underlying atherosclerotic disease.

By Suzanne Elvidge • Sept. 21, 2016

Ultragenyx gets lift from early data on bone drug

The California-based biotech is focused on development of therapies for rare and ultra-rare diseases. 

By Suzanne Elvidge • Sept. 20, 2016

Vical stumbles with latest vaccine failure

The San Diego-based drugmaker announced negative results for a mid-stage trial of their vaccine in kidney transplant patients. 

By Lisa LaMotta • Sept. 19, 2016