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Johnson & Johnson Innovation inks 17 collaborations

Friday, June 12, 2015 12:02 PM

Johnson & Johnson Innovation has announced 17 new collaborations with research institutions and healthcare companies, bringing the total number of collaborations formed since the 2013 launch of Johnson & Johnson Innovation to more than 200. Johnson & Johnson Innovation seeks to identify and advance scientific innovation across the Johnson & Johnson segments of Pharmaceutical, Medical Devices and Consumer businesses.

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Quest Diagnostics

Altan Pharma acquires Spain-based pharma GES Group

Friday, June 12, 2015 10:33 AM

Altan Pharma, an Irish specialty pharmaceutical company has acquired a privately held group of Spanish companies, The GES Group. The GES Group develops, manufactures and markets specialty injectable drugs. GES, headquartered in Spain, is comprised of three operating companies: GES Genéricos Españoles Laboratorio, Genfarma Laboratorio and Biomendi. 

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Schulman IRB breaks ground on new RTP location

Friday, June 12, 2015 10:18 AM

Schulman Associates IRB, a central IRB in customer service and technology, recently began build-out of its new office space on Laboratory Drive in Research Triangle Park, Durham, N.C. The location will house review board and administrative staff, including IT, operations and customer service professionals.

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FDA grants Breakthrough designation for Actemra in Systemic Sclerosis

Thursday, June 11, 2015 12:59 PM

Genentech, a member of the Roche Group, has announced that the FDA has granted Breakthrough Therapy designation status to Actemra (tocilizumab) for systemic sclerosis, also known as scleroderma. This designation is intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases and to help ensure patients have access to them as soon as possible. Genentech also has initiated a phase III study in systemic sclerosis (NCT02453256), a disease for which there are inadequate treatment options.

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Arrowhead receives Orphan designation for liver disease treatment ARC-AAT

Thursday, June 11, 2015 12:57 PM

The FDA has granted Arrowhead Research’s ARC-AAT Orphan Drug designation. ARC-AAT is Arrowhead’s RNAi-based therapeutic candidate being investigated for the treatment of liver disease associated with Alpha-1 Antitrypsin Deficiency (AATD), a rare genetic disease that severely damages the liver and lungs of affected children and adults. Arrowhead currently is conducting part B of a phase I study of ARC-AAT in patients with PiZZ genotype AATD.

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FDA grants Orphan designation to Agios’ AG-120 for leukemia

Thursday, June 11, 2015 12:56 PM

The FDA has granted Agios Pharmaceuticals’ Orphan Drug designation for AG-120 for treatment of patients with acute myelogenous leukemia (AML). AG-120 is an oral, first-in-class IDH1 mutant inhibitor being evaluated in a phase I clinical trial in patients with advanced hematologic malignancies that carry an IDH1 mutation.

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bluebird bio completes NIH review, moved forward with trial against recommendation

Thursday, June 11, 2015 12:34 PM

bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies, has completed the NIH Recombinant DNA Advisory Committee's (RAC) public review of the HGB-208 pediatric study protocol for bluebird bio's LentiGlobin BB305 product candidate in beta-thalassemia major. The RAC recommendation was to delay initiation of the study in the U.S. for one to two years. This recommendation has no effect on the HGB-207 protocol plan.

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Theorem Clinical Research, Decision Driver Analytics host mobile medical applications webinar

Thursday, June 11, 2015 12:04 PM

Theorem Clinical Research, a global CRO based in King of Prussia, Pa., and Decision Driver Analytics, a Asheville, N.C.-based provider of product life cycle value analysis and health economic insight for drug and medical device developers, will host the webinar, “Embracing a Mobile Medical App in a Clinical Development Strategy to Improve Clinical Outcomes, Increase ROI and Lower Costs,” at 10 a.m. June 25 (EDT).

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GlobeImmune restructures, cuts “majority” of workforce

Thursday, June 11, 2015 12:03 PM

GlobeImmune, a biopharmaceutical company based in Louisville, Colo., will eliminate the majority of positions in its workforce. This is not expected to have an impact on ongoing clinical trials being conducted by its collaborators in oncology and hepatitis B.

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Sanford Consortium, Takeda partner in $10M innovation alliance

Thursday, June 11, 2015 11:58 AM

The Sanford Consortium for Regenerative Medicine in La Jolla, Calif., and Takeda Pharmaceutical have agreed to establish a $10 million, five-year innovation alliance that would advance each organization's research missions. Specifically, translational research and proof-of-concepts research projects will be identified and generated with an ultimate goal of delivering innovative therapeutic products to patients.

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June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly


Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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