Theorem Clinical Research

Celgene

Celgene collaborates with Sutro Biopharma, inks option to acquire

Friday, October 24, 2014 01:09 PM

Sutro Biopharma, located in South San Francisco, has entered into a strategic collaboration and option agreement with Celgene to discover and develop multispecific antibodies and antibody drug conjugates (ADCs). This new agreement follows the December 2012 collaboration between the two companies and focuses on the field of immuno-oncology, while further broadening the Sutro platform for discovery, development and manufacture of best-in-class biotherapeutics.

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Report: Data sharing measures improving

Wednesday, September 10, 2014 02:45 PM

Citeline, an Informa business unit, has reported that clinical trial transparency, also known as responsible data sharing, is in a much healthier state than shown in previous studies.

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Bristol-Myers Squibb, Celgene collaborate on combination regimen

Thursday, August 21, 2014 01:44 PM

Bristol-Myers Squibb and Celgene have established a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of BMS’ investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), and Celgene’s nab technology-based chemotherapy Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in a phase I study.

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Celgene acquires Crohn's disease product from Nogra Pharma for $710M

Friday, April 25, 2014 10:58 AM

Celgene entered into a global license agreement with Nogra Pharma, a private pharmaceutical company based in Dublin, Ireland, to develop and commercialize GED-0301, an oral antisense DNA oligonucleotide targeting Smad7 mRNA for the treatment of moderate-to-severe Crohn's disease and other indications.

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Ian Read becomes PhRMA board chairman; Ken Frazier, George Scangos on board

Friday, April 18, 2014 10:37 AM

Ian C. Read, chairman and CEO of Pfizer, was elected chairman of the Pharmaceutical Research and Manufacturers of America (PhRMA). Read succeeds Robert J. Hugin, chairman and CEO of Celgene, as PhRMA's chairman. Also elected were Kenneth C. Frazier, chairman, president and CEO of Merck, as chairman-elect of the PhRMA board of directors, and George A. Scangos, Ph.D., CEO of Biogen Idec, as board treasurer.

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CEO Roundtable on Cancer launches data-sharing initiative to accelerate drug development

Thursday, April 10, 2014 01:03 PM

The CEO Roundtable on Cancer has launched Project Data Sphere, a new online oncology data-sharing platform using de-identified cancer patient information with the goal of accelerating drug discovery—by developing more efficient clinical trial protocols, epidemiological studies and, ultimately, new cancer therapies. 

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FDA approves Otezla to treat psoriatic arthritis

Friday, March 28, 2014 12:50 PM

The FDA has approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

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Orphan drug market expected to grow through 2018

Monday, March 24, 2014 02:51 PM

The returns on investment from orphan drugs are expected to help pharma companies overcome the impact of revenue loss due to expiry of patents of blockbuster drugs, according to ReportsnReports.com.

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Agios enrolls first patient in phase I study of AG-120

Friday, March 21, 2014 09:49 AM

Agios Pharmaceuticals, a company focused on discovering and developing novel drugs to treat cancer and inborn errors of metabolism (IEMs), has announced that the first patient has been dosed in a phase I study of AG-120 in patients with advanced hematologic malignancies with an isocitrate dehydrogenase-1 (IDH1) mutation. AG-120 is an orally available, selective, potent inhibitor of the mutated IDH1 protein, making it the first targeted therapeutic candidate to treat patients with cancers that harbor the IDH1 mutation.

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Abide Therapeutics, Celgene collaborate on immune disorders

Monday, March 3, 2014 12:50 PM

Abide Therapeutics has entered into a strategic collaboration with Celgeneto discover and develop new drugs in inflammation and immunology. Abide has pioneered innovative technologies to selectively target serine hydrolases, one of the largest enzyme families involved in regulating human physiology.

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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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