Theorem Clinical Research

Novartis

Fidelity Biosciences and Atlas Venture launch Unum Therapeutics

Wednesday, October 22, 2014 11:28 AM

Fidelity Biosciences and Atlas Venture, with participation from Sanofi-Genzyme BioVentures, have launched Unum Therapeutics, a company developing cellular immunotherapy to treat cancer. Fidelity Biosciences invests venture capital in biopharmaceutical, medical technology, healthcare information technology and healthcare service companies, while Atlas Venture is an early-stage investor. All three are based in Cambridge, Mass.

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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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Covance, Novartis collaborate to develop a clinical data warehouse

Wednesday, October 15, 2014 01:21 PM

Covance has entered an in-kind collaboration with Novartis Institutes for Biomedical Research (NIBR) to accelerate the development of a state-of-the-art clinical data warehouse designed to support data integration and meta-analysis for preclinical and clinical research.

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Oxford BioMedica, Novartis colaborate

Monday, October 13, 2014 08:57 AM

Oxford BioMedica, a U.K. gene and cell therapy company, has signed contracts with Novartis which build on a collaboration between the companies announced May 2013.

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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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Immutep to be acquired by Prima BioMed

Friday, October 3, 2014 11:04 AM

Immutep, an Orsay, France-based, late stage private biopharmaceutical company focused on immuno-oncology, has reached an agreement to be acquired by Prima BioMed, a Sydney, Australia-based developer of personalized immunocellular therapeutic products for cancer. Prima will pay up to approximately $28 million through a combination of cash, shares and warrants, subject to the achievement of certain performance milestones.

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Novartis to open Center for Advanced Cellular Therapeutics at University of Pennsylvania

Monday, September 15, 2014 12:29 PM

The University of Pennsylvania’s alliance with Novartis has unveiled plans for the construction of a first-of-its-kind Center for Advanced Cellular Therapeutics (CACT) on the Penn Medicine campus in Philadelphia.

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Bay Area BioEconomy Initiative appoints Pablo Cagnoni to steering committee

Friday, September 12, 2014 01:01 PM

The Bay Area BioEconomy Initiative (BAB) has named Pablo J. Cagnoni, M.D., president of Onyx Pharmaceuticals, to its steering committee. Onyx, an Amgen subsidiary, is engaged in the development and commercialization of innovative therapies to improve the lives of people with cancer.

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Mallinckrodt appoints new leaders following completion of Questcor acquisition

Thursday, August 28, 2014 02:07 PM

Mallinckrodt, an Ireland-based global specialty pharmaceutical company, has announced that Gary Phillips, M.D., current senior vice president and chief strategy officer, has been appointed senior vice president and president of the company’s autoimmune and rare disease business, which includes the commercial organization supporting H.P. Acthar Gel.

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Novartis provides drug candidate compounds to TB Alliance

Thursday, August 21, 2014 01:48 PM

Novartis has signed an exclusive worldwide licensing agreement with the Global Alliance for TB Drug Development (TB Alliance), which has locations in the U.S., Brussels and South Africa, for compounds to fight tuberculosis (TB) that have been discovered at the Novartis Institutes for Tropical Diseases (NITD).

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October 20

Toronto Star, with FDA data, exposes weaknesses in Health Canada's clinical trial, inspection oversight

Crowdsourcing effort aims to fund updated online social media guide for sponsor interaction with patients

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September

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

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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