Theorem Clinical Research

FDA

Novartis publishes CTL019 data for acute lymphoblastic leukemia

Thursday, October 16, 2014 11:55 AM

Novartis and the University of Pennsylvania's Perelman School of Medicine have announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine (NEJM) evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor (CAR) therapy CTL019.

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FDA approves Ofev to treat idiopathic pulmonary fibrosis

Thursday, October 16, 2014 11:49 AM

The FDA has approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

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Celerion joins Cardiac Safety Research Consortium

Thursday, October 16, 2014 07:00 AM

Celerion, a Lincoln, Neb.-based provider of cardiovascular safety services in early clinical research, has become a member of the Cardiac Safety Research Consortium (CSRC). Celerion will engage with other thought leaders on key issues that impact cardiovascular safety, including discussions of alternative approaches to ICH E14 to assess arrhythmia liability in early drug development.

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Bristol-Myers Squibb withdraws NDA with FDA for asunaprevir

Thursday, October 9, 2014 11:51 AM

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which currently is being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

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Chimerix receives Emergency Investigational NDA for Ebola

Thursday, October 9, 2014 11:45 AM

Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the FDA.

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Bristol-Myers Squibb, Novartis collaborate on NSCLC

Thursday, October 9, 2014 10:00 AM

Bristol-Myers Squibb has established a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of combining Bristol-Myers Squibb’s investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) with three molecularly targeted oncology therapies (Zykadia (ceritinib), INC280 and EGF816) from Novartis. Novartis will conduct two phase I/II studies focused on non-small cell lung cancer (NSCLC).

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Report: Past drug failures vital to drug development process

Wednesday, October 8, 2014 01:36 PM

A number of investigational cancer medicines that did not succeed in clinical trials, so-called "failures," are a critical part of the drug development process, according to a report by the Wash. D.C.-based Pharmaceutical Research and Manufacturers of America (PhRMA).

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Tenax Therapeutics halts phase IIb trial

Tuesday, October 7, 2014 01:00 PM

Tenax Therapeutics, formerly named Oxygen Biotherapeutics, a Morrisville, N.C.-based specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, has announced that the company, with unanimous approval from the board of directors, has elected to stop the current phase IIb trial for its Oxycyte drug candidate and consider strategic alternatives for the program moving forward. The company will review the data generated on the patients enrolled in the trial to date.

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Actavis to acquire Durata Therapeutics

Monday, October 6, 2014 04:00 PM

Actavis, a global specialty pharmaceutical company based in Dublin, Ireland, and Durata Therapeutics, an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, headquartered in Chicago, Ill., have entered into a definitive merger agreement.

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FDA seeks permanent injunction against Pharmaceutical Innovations

Monday, October 6, 2014 03:46 PM

The FDA is seeking a permanent injunction to stop Pharmaceutical Innovations, and its principal officer, Gilbert Buchalter, from manufacturing, marketing, selling and distributing medical products until they come into compliance with all applicable FDA requirements.

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October 13

First Sunshine Act data posted online; many cite errors, lack of context to help consumers understand payments

In appreciation: Felix Gyi will be remembered for his passion, leadership and desire to educate, pay it forward

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

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CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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