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AveXis gains EMA Orphan designation from for spinal muscular atrophy treatment

Thursday, June 25, 2015 11:02 AM

The EMA has granted Orphan Drug designation to a gene transfer therapeutic currently in clinical development in the U.S. for the treatment of type 1 spinal muscular atrophy (SMA). AveXis, a gene therapy company developing treatments for rare and life-threatening genetic diseases, received Orphan Drug designation for SMA in the U.S. in Oct. 2014.

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Quest Diagnostics

Pfizer enrolls first patient in phase III sickle cell disease trial

Thursday, June 25, 2015 10:54 AM

Pfizer has announced that the first patient has been enrolled in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study—a phase III clinical trial assessing the efficacy and safety of rivipansel for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease who are 6 years of age or older.

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Broad Institute, Google Genomics partner to expand access to research tools

Thursday, June 25, 2015 10:26 AM

Broad Institute of MIT and Harvard is teaming up with Google Genomics to explore how to break down major technical barriers that increasingly hinder biomedical research by addressing the need for computing infrastructure to store and process enormous datasets, and by creating tools to analyze such data and unravel long-standing mysteries about human health.

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NeoStem finalizes name change to Caladrius Biosciences

Thursday, June 25, 2015 10:17 AM

Caladrius Biosciences, a cell therapy company with a late-stage clinical program for immuno-oncology, has finalized its corporate name change from NeoStem to Caladrius.

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Huntingdon Life Sciences, Harlan Laboratories to become Envigo

Wednesday, June 24, 2015 11:21 AM

Huntingdon Life Sciences (HLS) and Harlan Laboratories, a U.K. CRO, have announced that the combined companies will be called Envigo.

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Claritas Genomics, Genetic Alliance partner on patients’ results sharing

Wednesday, June 24, 2015 10:38 AM

Claritas Genomics, a Cambridge, Mass.-based genetic diagnostic laboratory, and Genetic Alliance, a nonprofit health advocacy organization based in Wash. D.C., announced a partnership to help patients and families find and participate in relevant research opportunities that will advance understanding of individual genetic disorders and development of new therapies.

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ASBM responds to Australia’s breaks with other regulators on biosimilar substitution

Wednesday, June 24, 2015 10:20 AM

The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.

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PrimeGen Biotech opens new research facility, HQ in California

Wednesday, June 24, 2015 10:16 AM

PrimeGen Biotech, a privately-held research firm, has opened a new 10,000 square-foot research facility located in Santa Ana, Calif. Founded by co-founder of AST Computers and former CEO of SRS Labs, Thomas C.K. Yuen plans to utilize PrimeGen's new research facility and his experience in marketing technologies to lead PrimeGen's team of research scientists in the discovery of new breakthroughs in stem cell science, and bringing advanced treatments of degenerative and aging related diseases to market.

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FDA, TransCelerate, INC Research to speak at 10th Annual Global Site Solutions Summit

Wednesday, June 24, 2015 10:11 AM

The Society for Clinical Research Sites (SCRS), a global trade organization representing the interests of clinical research sites, has announced an invigorated, solution-driven program for the 10th Annual Global Site Solutions Summit. The Summit will be Oct. 8-11, in Amelia Island, Fla. The annual meeting, which attracts investigators, site executives and industry executives from around the globe, is inclusive of interactive sessions, knowledge and best practice sharing, and networking opportunities, centered around the collaboration-focused theme “Better Together.”

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Juniper, OxSonics partner for cancer drug delivery platform

Wednesday, June 24, 2015 10:02 AM

Juniper Pharma Services, a contract development and manufacturing organization (CDMO) subsidiary of Juniper Pharmaceuticals, has entered into a long-term collaboration with OxSonics to support the development, scale-up and GMP manufacturing of OxSonics' proprietary "sono-sensitive particles." OxSonics was established in July 2013 to develop and commercialize therapeutic ultrasound advancements invented at the University of Oxford's Institute of Biomedical Engineering.

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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

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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