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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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Quest Diagnostics

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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OpenClinica releases Participate to capture research data directly from patients

Thursday, June 11, 2015 11:57 AM

OpenClinica, a Boston-based provider of software for electronically capturing clinical research data, has launched Participate, a mobile, device independent solution for engaging participants in clinical research. Participate broadens possibilities for clinical research, by making it easier to meaningfully engage patients and collect high quality, timely data from patients in a way that is convenient for them.

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ERT launches Site Selection Analytics for Insights Cloud

Thursday, June 11, 2015 11:56 AM

ERT, a global provider of patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions headquartered in Philadelphia, Pa., has added the Site Selection Analytics within the ERT Insights Cloud. Site Selection Analytics joins the Insights Cloud suite of data analytics, visualization and workflow applications that examine real-time clinical data and deliver actionable insights and process optimization to pharmaceutical companies and CROs.

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Panasonic Healthcare acquires Bayer Diabetes

Wednesday, June 10, 2015 11:18 AM

Panasonic Healthcare Holdings (PHCHD), based in Tokyo, has inked an agreement to acquire Bayer Diabetes Care (BDC) for $1.2 billion to create a global diabetes care solutions business. BDC is a provider of blood glucose monitoring systems to people with diabetes and healthcare professionals around the world. It was formed as a business unit within Bayer and is present in more than 125 countries. It generated sales of $1 billion in 2014.

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With buyout option, Celgene collaborates with Lycera

Wednesday, June 10, 2015 11:17 AM

Lycera, a U.S.-based privately held biopharmaceutical company developing breakthrough immune modulatory medicines, has formed an exclusive global collaboration with Celgene to take forward Lycera's proprietary pipeline for cancer and immune-mediated diseases.

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CWWeekly

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

July

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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The CenterWatch Monthly.

The CenterWatch Monthly

June

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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