Industry News

Gilead announces FDA priority review designation for fixed-dose treatment of HIV

Centerwatch - Fri, 2017-08-11 13:55

Gilead Sciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for an investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI) and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection. Gilead filed […]

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Mark Rothera appointed CEO at Orchard Therapeutics

Centerwatch - Fri, 2017-08-11 13:25

Orchard Therapeutics has announced the appointment of Mark Rothera as President and Chief Executive Officer. Rothera brings 28 years of experience in the biopharmaceutical industry including driving the transition of multiple emerging biotechnology companies from R&D stage to commercialization. During his career, he has focused on bringing novel therapies to market for patients with rare […]

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Galapagos announces phase IIa results with GLPG1690 in IPF patients

Centerwatch - Fri, 2017-08-11 09:03

Galapagos NV has announced positive topline results with its autotaxin inhibitor GLPG1690 in patients with idiopathic pulmonary fibrosis (IPF) in the FLORA phase IIa trial. FLORA was an exploratory, randomized, double-blind, placebo-controlled trial investigating a once-daily oral dose of GLPG1690. The drug candidate was administered for 12 weeks in 23 IPF patients, 17 of whom received […]

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Iovance Biotherapeutics appoints Timothy Morris CFO

Centerwatch - Thu, 2017-08-10 15:29

Iovance Biotherapeutics, a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, announced the appointment of Timothy E. Morris as Chief Financial Officer of the company, effective August 14, 2017. Morris has over 30 years of strategic financial and operating experience in the biotechnology sector. “We are very pleased to welcome Tim […]

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Ocugen receives FDA Orphan designation for ocular graft versus host disease

Centerwatch - Thu, 2017-08-10 15:25

Ocugen, a clinical stage biopharmaceutical company developing novel treatments for sight-threatening diseases, announced the FDA has granted orphan drug designation (ODD) for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease (oGVHD). Ocular GVHD is a common complication that occurs in 40-60% of patients who have undergone allergenic hematological stem cell transplantation […]

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PRA Health Sciences to acquire Symphony Health Solutions

Centerwatch - Thu, 2017-08-10 11:24

PRA Health Sciences, a CRO, has signed a definitive agreement to acquire Symphony Health Solutions, a privately held best-in-class provider of data, analytics and consulting solutions to the life sciences market. The acquisition reflects PRA’s commitment to a more agile, flexible and adaptive future of clinical development in which technology allows research to integrate seamlessly into […]

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BioreclamationIVT acquires Asterand Bioscience

Centerwatch - Thu, 2017-08-10 09:43

BioreclamationIVT, a provider of biospecimens and related services, has acquired Asterand Bioscience, a global provider of high quality, well-characterized human tissue and research solutions with a focus on the oncology market. Asterand Bioscience advances drug research by accelerating target identification and biomarker validation, and improving drug candidate selection to increase the likelihood of clinical success. […]

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AGTC files IND for X-linked retinitis pigmentosa treatment

Centerwatch - Thu, 2017-08-10 09:39

Applied Genetic Technologies, a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, has filed an Investigational New Drug application (IND) with the FDA to conduct a phase I/II clinical trial of the company’s gene therapy product candidate for the treatment of X-linked retinitis pigmentosa (XLRP) […]

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Tyler Pugsley joins Medable as VP of Life Sciences

Centerwatch - Thu, 2017-08-10 09:35

Medable, an application and analytics platform for healthcare, announced Tyler Pugsley has joined the company as Vice President of Life Sciences. Pugsley was the Director of Business Development for IBM Watson Health. “Medable is leading a new era in clinical research, in which technology enables clinical trials to be taken directly to patients, anytime, anywhere,” […]

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Certara adds externalization technology to its D360 scientific informatics platform

Centerwatch - Thu, 2017-08-10 09:32

Certara, a global provider of model-informed drug development and regulatory science, has added externalization technology to its D360 scientific informatics platform. The resulting new product, D360 Partner, facilitates collaboration between sponsors and their external research partners. Those external collaborators could include academic institutions, contract research organizations or third-party research groups. Those partners all have similar […]

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Ohio State Wexner Medical Center develops regenerative medicine breakthrough

Centerwatch - Wed, 2017-08-09 15:30

Researchers at The Ohio State University Wexner Medical Center and Ohio State’s College of Engineering have developed a new technology, Tissue Nanotransfection (TNT), that can generate any cell type of interest for treatment within the patient’s own body. This technology may be used to repair injured tissue or restore function of aging tissue, including organs, blood vessels and nerve […]

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Cempra, Melinta merge to form commercial-stage anti-infectives company

Centerwatch - Wed, 2017-08-09 15:03

Cempra, Inc., a clinical-stage pharmaceutical company focused on developing differentiated anti-infectives for acute care and community settings to meet critical medical needs in the treatment of infectious diseases, and Melinta Therapeutics, a privately held company focused on discovering, developing and commercializing novel antibiotics to treat serious bacterial infections, have announced that the companies have entered into […]

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First FDA-approved treatment for ALS in 22 years now available in U.S.

Centerwatch - Wed, 2017-08-09 10:42

Mitsubishi Tanabe Pharma America announced RADICAVA (edaravone), an intravenous therapy indicated for all adult patients diagnosed with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, is now available for treatment in the U.S. RADICAVA, the first FDA-approved ALS treatment option in more than 20 years, has been demonstrated to slow the decline in the loss of […]

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ACRP, The Avoca Group announce strategic clinical research partnership

Centerwatch - Wed, 2017-08-09 09:00

The Association of Clinical Research Professionals (ACRP) and the Avoca Group have announced a new strategic partnership aimed at driving quality, standardization and collaboration in clinical research. The Avoca Group, whose clients include top five pharmaceutical companies and global contract research organizations (CROs), is a driving force behind the continuous improvement of outsourced clinical research […]

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Veritas Genetics acquires Curoverse for AI and Machine Learning in Genomics

Centerwatch - Wed, 2017-08-09 08:32

Veritas Genetics, the genome company, announces the acquisition of Boston-based Curoverse, the preeminent computing and bioinformatics company behind the Personal Genome Project (PGP) at Harvard Medical School, and creator of the open-source platform Arvados. Curoverse software is used by industry leaders such as the Wellcome Trust Sanger Institute to manage, process and share petabytes of genomic and biomedical data […]

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Bristol-Myers Squibb to acquire IFM Therapeutics

Centerwatch - Wed, 2017-08-09 08:29

Bristol-Myers Squibb and IFM Therapeutics (IFM) announced that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders. The acquisition will give Bristol-Myers Squibb full […]

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QPS Delaware expands translational medicine capabilities

Centerwatch - Wed, 2017-08-09 08:22

QPS Holdings, a full-service GLP/GCP-compliant CRO providing testing services to support preclinical and clinical research and development, is investing in additional technical personnel and laboratory capacity for translational medicine at its flagship Delaware Technology Park facility. This significant expansion will enable QPS Delaware to process the high sample volumes required for phase III clinical drug […]

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Takeda, Cardurion launch cardiovascular development partnership

Centerwatch - Wed, 2017-08-09 08:12

Takeda Pharmaceutical and Cardurion Pharmaceuticals announced the creation of a new cardiovascular development partnership. Cardurion, a recently launched Boston-area based biotechnology company, is focused on the development of novel, next-generation therapeutics for the treatment of heart failure and other cardiovascular diseases. Cardurion is led by two physician scientists with extensive experience in cardiovascular science, medicine […]

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HitGen, LEO Pharma partner

Centerwatch - Wed, 2017-08-09 08:05

HitGen announced that the company has entered into a multi-target multi-year collaboration with LEO Pharma to discover novel small molecule leads for multiple therapeutic targets of interest to LEO Pharma. According to the agreement, HitGen will use its advanced technology platform, based on DNA-encoded library design, synthesis and screening to discover novel leads which will […]

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Charles River Laboratories acquires Brains On-Line

Centerwatch - Wed, 2017-08-09 08:02

Charles River Laboratories International has acquired Brains On-Line, a CRO providing critical data that advances novel therapeutics for the treatment of central nervous system (CNS) diseases. With operations in San Francisco, the Netherlands, and Germany, Brains On-Line is considered the world’s premier provider of microdialysis for CNS research. Additionally, Brains On-Line offers sophisticated in vivo efficacy and pharmacokinetics testing to […]

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