Industry News

Postmarketing Requirements and Commitments: Reports

FDA News - Fri, 2016-11-25 08:57
Added: Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability (FY2012)
Categories: Industry News

QuintilesIMS, Bristol-Myers Squibb, Lilly, Merck KGaA, Pfizer partner

Centerwatch - Wed, 2016-11-23 12:25

QuintilesIMS will lead a collaborative initiative involving founding partners Bristol-Myers Squibb, Eli Lilly, Merck KGaA and Pfizer, which aims to provide clearer and more proactive insight into how anti-cancer treatments are used in a real-world setting across key European markets. Currently, there are major information gaps and inconsistencies in knowledge about the real-world use of […]

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Categories: Industry News

Shire to establish rare disease innovation hub in Massachusetts

Centerwatch - Wed, 2016-11-23 12:21

Shire will expand its operations in Cambridge, Massachusetts, establishing a rare disease innovation hub and increasing its footprint in the heart of Kendall Square. Shire and BioMed Realty have signed a lease for a 343,000-square-foot building at 500 Kendall Street. Shire’s lease begins in Q3, 2018, with occupancy anticipated for Q1, 2019. With the adjacent space […]

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Categories: Industry News

Triphase announces full enrollment results for malignant glioma trial

Centerwatch - Wed, 2016-11-23 09:38

Triphase Accelerator, a private drug development company dedicated to advancing novel compounds through clinical phase II proof-of-concept, has announced positive full enrollment results from its multicenter, open label, phase I study evaluating marizomib (MRZ) in combination with bevacizumab (BEV) in patients with WHO grade IV malignant glioma. Triphase separately announced on November 17, 2016 that […]

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Categories: Industry News

Delaware BioScience Association announces new president

Centerwatch - Mon, 2016-11-21 14:00

The Delaware BioScience Association (Delaware Bio) has announced that its founding President Bob Dayton is retiring after 10 years of achieving continuous growth and increasing influence. As of February 1, Dayton will be succeeded by Helen Stimson, who will leave her current role as vice president and general manager of the Chemistries and Supplies Division at […]

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Categories: Industry News

Horizon Discovery enters Chinese Clinical Diagnostics Market

Centerwatch - Mon, 2016-11-21 13:56

Horizon Discovery Group, a leader in the application of gene editing technologies, has entered into partnerships with three leading Chinese diagnostic kit developers. Under the terms of the agreements, Horizon will provide HDx Reference Standards for novel Next Generation Sequencing (NGS) assay development, clinical trials, and ultimately for inclusion as in-kit controls under Original Equipment […]

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Categories: Industry News

BioSpecifics Technologies announces positive data from phase IIb cellulite study

Centerwatch - Mon, 2016-11-21 13:53

BioSpecifics Technologies, a biopharmaceutical company that originated and continues to develop collagenase based-therapies with a first in class collagenase-based product collagenase clostridium histolyticum, or CCH, marketed as XIAFLEX in the U.S. and Xiapex in Europe today announced positive, highly statistically significant results from a phase IIb study of CCH for the treatment of cellulite, or edematous fibrosclerotic panniculopathy. […]

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Categories: Industry News

ContextMedia acquires AccentHealth

Centerwatch - Mon, 2016-11-21 12:54

ContextMedia, a healthcare decision platform, will acquire AccentHealth, which provides best-in-class patient education at the point of care, in an all-cash purchase. Through this acquisition, ContextMedia becomes the largest healthcare decision platform at the point of care in the U.S., with a rapidly growing reach across clinics, hospitals and health systems. In 2016, ContextMedia has been […]

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Categories: Industry News

Biogen adds management to hemophilia spin-off Bioverativ

Centerwatch - Mon, 2016-11-21 12:50

Biogen has announced the addition of two members to the executive management team of Bioverativ, Biogen’s planned spin-off company focused on the discovery, research, development and commercialization of treatments for hemophilia and other blood disorders. Rogerio Vivaldi, M.D., will serve as executive vice president and chief global therapeutic operations officer of Bioverativ, and John T. Greene […]

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Categories: Industry News

Gilead Sciences promoted James R. Meyers to EVP, Worldwide Commercial Operations

Centerwatch - Mon, 2016-11-21 12:24

Gilead Sciences has announced the promotion of James R. Meyers to executive vice president, Worldwide Commercial Operations, with responsibility for commercial operations in North America, Europe and Japan. Meyers will become an officer of the company and member of Gilead’s senior leadership team. Mr. Meyers joined Gilead in 1996 as a regional sales director and has been the senior vice president […]

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Categories: Industry News

FDA approves Intrarosa for postmenopausal women experiencing pain during sex

Centerwatch - Mon, 2016-11-21 12:22

The FDA has approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). During menopause, levels of estrogen decline in […]

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Categories: Industry News

Kentucky startups join MassCONNECT Program

Centerwatch - Mon, 2016-11-21 12:03

Two medical device startup companies from Kentucky, Inscope Medical Solutions and Liberate Medical, have been selected to join the MassCONNECT mentoring program.  These companies are the first participants in MassCONNECT through the Kentucky—Massachusetts Turnpike, a partnership between the Kentucky Life Sciences Council (KLSC) and MassBio designed to foster collaboration between the two clusters and accelerate […]

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Categories: Industry News

MYnd Analytics, Carolina Partners to launch personalized mental health program

Centerwatch - Mon, 2016-11-21 10:46

MYnd Analytics and Carolina Partners in Mental Healthcare are teaming up to provide personalized care to veterans and civilians seeking quality evidence based mental health care. Carolina Partners, a 25 clinic outpatient psychiatry group practice based in Durham, N.C., is the first non-governmental site to launch the SMART-MD protocol for Veterans. This randomized, double-blind, multi-site […]

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Categories: Industry News

Broad Institute, Intel partner on of genomic data

Centerwatch - Mon, 2016-11-21 10:37

The Broad Institute of MIT and Harvard has announced a $25 million collaboration with Intel to scale researchers’ ability to analyze massive amounts of genomic data from diverse sources worldwide. Through a five-year collaboration, researchers and software engineers at the new Intel-Broad Center for Genomic Data Engineering will build, optimize, and widely share new tools and infrastructure […]

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Categories: Industry News

Bristol-Myers Squibb, Enterome form immuno-oncology collaboration

Centerwatch - Mon, 2016-11-21 10:29

Bristol-Myers Squibb and Enterome, a developer of pharmaceuticals and diagnostics based on the gut microbiome, announced that they have entered into an Immuno-Oncology focused collaboration agreement for the discovery and development of microbiome-derived biomarkers, drug targets and bioactive molecules to be developed as potential companion diagnostics and therapeutics for cancer. Additionally, the collaboration will seek to […]

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Categories: Industry News

QuintilesIMS to acquire TKL Research’s Clinical Trials Division

Centerwatch - Mon, 2016-11-21 10:26

TKL Research, a dermatology specialty CRO, has signed an agreement to sell its Clinical Trials Division (CTD) to QuintilesIMS. Upon closing, TKL’s CTD will become part of Novella Clinical, a Quintiles company. Moving forward, TKL Research will retain its Research Clinics Division (RCD) as TKL Research, which operates full-service inpatient and outpatient phase I facilities […]

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Categories: Industry News

Seven Bridges to integrate platform with SolveBio

Centerwatch - Mon, 2016-11-21 10:21

Seven Bridges, a biomedical data analysis company, and SolveBio have announced the integration of their complementary platforms for genomic data analysis. The integration of Seven Bridges’ platform for cloud-based biomedical data analysis with SolveBio enables biotech and pharmaceutical researchers to seamlessly transition from the analysis of large NGS datasets to clinical analysis and interpretation, speeding the progress […]

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Categories: Industry News

Medidata introduces eConnect Partner Program

Centerwatch - Mon, 2016-11-21 09:56

Medidata, a global provider of cloud-based solutions and data analytics for clinical research, has launched the Medidata eConnect Partner Program. The collaborative initiative will enable the seamless integration of healthcare data—from electronic health records (EHRs), electronic medical records (EMRs), and clinical trial electronic source data (eSource) systems—with the Medidata Clinical Cloud, a platform powering clinical trials for nearly […]

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Categories: Industry News

Movember: Bringing men’s health to the forefront

Centerwatch - Mon, 2016-11-21 07:00

Globally, men’s health outcomes are significantly worse than women’s—a paradox, given that more men participate in clinical trials than women. Across the world, men die an average of six years younger than women. November has become the month for turning the public’s attention to the unmet health needs of men. Dubbed “Movember,” this is the […]

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Categories: Industry News

The CenterWatch Weekly, November 21, 2016

Centerwatch - Mon, 2016-11-21 07:00

DrugDev acquires SecureConsent DrugDev has acquired SecureConsent, an electronic informed consent (eConsent) pro­vider, in a move that expands the company’s suite of technology offerings designed to improve the efficiency of clinical operations at investigative sites. No financial terms of the deal were disclosed. New specialty IRB targets social science research A major provider of clinical research […]

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