Roche stays competitive in I/O race

Tecentriq helped previously treated NSCLC patients live longer compared to standard chemotherapy, regardless of PD-L1 expression. 

By Suzanne Elvidge • Oct. 10, 2016

RedHill adds option for Phase 3 early stop in Crohn's

The biotech is confident an interim analysis next year in its Phase 3 trial will show positive results. 

By Suzanne Elvidge • Oct. 7, 2016

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

Prescribed Reading: Pharma re-focuses, face-off at ESMO, Hep C boxed

Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.

By Lisa LaMotta • Oct. 6, 2016

Alnylam abandons RNA drug after patient deaths

While the company said the decision would not affect its other RNAi programs, shares plunged by over 45% on the news. 

By Joe Cantlupe • Oct. 6, 2016

Scynexis buoyed by mid-stage data, new funding

Positive results from two Phase 2 studies bolstered the profile of the company's lead antifungal candidate. 

By Suzanne Elvidge • Oct. 6, 2016

AstraZeneca's Brilinta loses out to old standby

The setback, six months after a failure in a major stroke study, could put a major dent in the company's efforts to grow revenues from the drug. 

By Joe Cantlupe • Oct. 5, 2016

Tracon readies Phase 3 cancer trial

The San Diego-based biopharma plans to begin late-stage testing for its angiosarcoma drug by year end. 

By Suzanne Elvidge • Oct. 4, 2016

Cempra charging ahead in NASH race

The company reported positive Phase 2 interim results for its NASH drug, just as competition to be first to market heats up among other players in the space. 

By Joe Cantlupe • Oct. 3, 2016

Regeneron and Sanofi tout dupilumab success

Data from two Phase 3 studies, published in NEJM over the weekend, show the drug helped clear symptoms of patients with severe eczema. 

By Suzanne Elvidge • Oct. 3, 2016

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

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