Clinical Trials: Page 111
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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 -
Explore the Trendline➔
National Institutes of Allergy and Infectious Diseases. (2016). "Human natural killer cell" [Micrograph]. Retrieved from Flickr.TrendlineCell 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 -
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 -
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