Theorem Clinical Research

United States

PharmaTimes launches 2015 Clinical Researcher of the Year competition

Wednesday, October 29, 2014 08:21 AM

The 2015 PharmaTimes Clinical Researcher of the Year-The Americas competition is open for entry. All research professionals are encouraged to enter.

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Burzynski Research Institute to launch diffuse intrinsic brainstem glioma trial

Monday, October 27, 2014 01:38 PM

Burzynski Research Institute (BRI) has announced that the FDA has given the company permission to conduct an open-label study of Antineoplastons A10 and AS2-1 in patients >3 months of age with a diffuse intrinsic brainstem glioma (DIPG).

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Synchrogenix appoints two new global submissions directors

Monday, October 27, 2014 01:30 PM

Synchrogenix Information Strategies, a regulatory writing company headquartered in Wilmington, Del., has added two new global submissions directors: Kelley Hill and Aaron Bernstein.

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FDA approves new treatment for rare form of hemophilia

Monday, October 27, 2014 01:24 PM

The FDA has approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVIII] deficiency).

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SRI International opens clinical trial unit in Michigan

Monday, October 27, 2014 01:04 PM

SRI Biosciences, a division of SRI International, a California-based independent nonprofit research institute, has completed construction of an early-phase clinical trial facility in Plymouth, Mich. The 9,400-square-foot unit, located in the Michigan Life Science Innovation Center, now is open and fully equipped for early-stage human research studies of new medicines and medical devices. 

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Xiaflex approved for concurrent treatment in Dupuytren's contracture patients

Friday, October 24, 2014 12:48 PM

Auxilium Pharmaceuticals has announced that the FDA has approved a supplemental Biologics Application (sBLA) for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.

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TWi Biotechnology receives Orphan Drug designation for AC-201

Thursday, October 23, 2014 03:29 PM

TWi Biotechnology has received the designation of Orphan Drug from the FDA for using AC-201 to treat epidermolysis bullosa (EB). TWi Biotechnology has developed proprietary formulations to be used topically for the indication of EB.

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Adheris Health, Behavioral Insights Group launch ethnographic study

Thursday, October 23, 2014 01:51 PM

Adheris Health, an inVentiv Health company and a provider of medication adherence programs, has announced the start of the next phase of an ethnographic study into how Americans make healthcare decisions and the role of American culture in influencing health behaviors.

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aTyr Pharma appoints John C. McKew vice president, research

Thursday, October 23, 2014 01:45 PM

aTyr Pharma, an innovative rare disease therapeutics enterprise, has announced that John C. McKew, Ph.D., has joined the company as vice president, research. McKew brings more than two decades of experience in translational research, including key leadership positions at the NIHWyeth Research and Genetics Institute (prior to its acquisition by Wyeth). McKew will lead aTyr's efforts to expand and translate its novel Physiocrine biology into meaningful therapeutics to treat rare, grave immune-driven disorders.

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ALS ACT, ALS Association, Northeast ALS Consortium request proposals

Thursday, October 23, 2014 01:12 PM

ALS ACT, a novel academic-foundation-industry partnership; the ALS Association, a Wash. D.C.-based national nonprofit organization; and the translational Northeast ALS Consortium (NEALS) clinical trials network have announced a call for phase II clinical trial applications for novel, high-potential treatments in amyotrophic lateral sclerosis (ALS).

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October 27

NIH’s I-Corps boot camp aims to transform researchers into better businesspeople before they launch products

Covance, Frenova form partnership to share patient databases, find effective treatments for renal disease

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October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

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Today's fastest, most economical sponsors
Standout sponsors reveal how they shorten regulatory, clinical cycle times

From the trenches: Sites' eye view of state of the industry
CW’s first site focus groups uncover frustration with 'progress,' but a passion for their mission

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