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Sen. Warren to push law establishing “swear jar” concept for drug companies facing fraud penalties to help fund NIH

Friday, January 23, 2015 02:40 PM

Democratic Senator Elizabeth Warren of Massachusetts told the audience at a national healthcare advocacy conference Thursday she will introduce a new law—the Medical Innovation Act—to advance medical research.

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BIO responds to President Obama's State of the Union speech

Friday, January 23, 2015 11:53 AM

The Biotechnology Industry Organization (BIO), a trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the U.S. and in more than 30 other nations, has issued a statement in response to President Obama's State of the Union speech.

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Syncona, UCLB form Autolus cancer immunotherapy company

Friday, January 23, 2015 11:47 AM

Syncona, a London-based subsidiary of the Wellcome Trust, and UCL Business, the wholly-owned technology transfer company of University College London (UCL), have announced the creation of Autolus, a London-based biopharmaceutical company focused on the development and commercialization of next-generation engineered T-cell therapies for hematological and solid tumors. Autolus is founded upon the work of Dr. Martin Pule, an academic clinical hematologist and thought-leader in T-cell engineering. Syncona has committed $33.5 million to Autolus in a Series A financing. Dr. Christian Itin, former CEO of Micromet, has joined the company as chairman.

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Sigma-Aldrich, VIB ink alliance on novel translational research tools

Friday, January 23, 2015 11:46 AM

Sigma-Aldrich's research business unit, which supports translational researchers by supplying the products, services and solutions needed to enable scientific discovery, has formed an alliance with VIB, a life science research institute based in Flanders, Belgium, focused on translational research in medical, agricultural and industrial applications. The alliance will focus on the commercialization and supply of new tools and technologies to help meet the evolving needs of translational researchers.

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Academy of Medical Royal Colleges not supporting Medical Innovation Bill

Friday, January 23, 2015 11:43 AM

The Academy of Medical Royal Colleges has released a statement on the proposed Medical Innovation Bill.

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Array to acquire Novartis BRAF inhibitor encorafenib (LGX818)

Friday, January 23, 2015 11:40 AM

Array BioPharma, based in Boulder, Colo., has reached a definitive agreement with Novartis Pharma to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in phase III development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals.

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CytRx announces FDA's removal of partial clinical hold for aldoxorubicin trials

Thursday, January 22, 2015 02:41 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced that the FDA has removed the partial clinical hold on the company's aldoxorubicin clinical trials. Enrollment and dosing of new patients now is permitted after study sites' Institutional Review Boards (IRBs) approve the revised trial protocols.

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VolitionRx begins first ovarian cancer detection study

Thursday, January 22, 2015 02:39 PM

VolitionRx, a Belgium-based life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, has signed an agreement to commence a pilot ovarian cancer study in collaboration with Singapore General Hospital (SGH). Blood and tissue samples collected from 40 patients will be assessed to establish the feasibility of VolitionRx's proprietary NuQ assays in detecting ovarian cancer. If this test proves to be accurate, it could offer hope as an early-stage screening tool.

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Celator Pharmaceuticals receives FDA Fast Track for CPX-351 for AML

Thursday, January 22, 2015 01:54 PM

The FDA granted Fast Track designation for Celator Pharmaceuticals’ CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

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INC enhances clinical delivery focus with executive leadership promotions

Thursday, January 22, 2015 01:38 PM

INC Research Holdings, a, global phase I to IV CRO based in Raleigh, N.C., has announced the promotions of Alistair Macdonald and Michael Gibertini, Ph.D., to key roles within the C-suite.

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CenterWatch Drugs in Clinical Trials
CWWeekly

January 19

Roche takes $1B majority stake in Foundation Medicine to use genomic testing to personalize oncology treatments

BRANY launches software, iPad app to streamline protocol creation for investigator-initiated trials

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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