Theorem Clinical Research

FDA

Wright Medical Group, Tornier to merge

Wednesday, October 29, 2014 01:29 PM

Wright Medical Group, a specialty orthopedic company that provides extremity and biologic solutions, and Tornier, a global medical device company, have entered a definitive merger agreement under which Wright and Tornier will combine in an all-stock transaction with a combined equity value of approximately $3.3 billion.

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Synageva BioPharma reports positive results from LAL Deficiency study

Monday, October 27, 2014 01:46 PM

Synageva BioPharma, a biopharmaceutical company developing therapeutic products for rare disorders, has announced results of sebelipase alfa for LAL Deficiency in two different trials.

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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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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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Cancer Innovation forum calls for improving cancer research ecosystem

Monday, October 27, 2014 12:58 PM

Accelerating the delivery of promising new cancer treatments depends on one critical requirement—ensuring patients are actively involved in the cancer research and drug development process from beginning to end.

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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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ProNAi Therapeutics adds five to senior management team

Thursday, October 23, 2014 03:17 PM

ProNAi Therapeutics, a private company dedicated to developing and commercializing a new class of therapies based on its proprietary DNAi platform, has added five seasoned executives to its senior management team.

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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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INC Research to perform FDA due diligence audit for Provectus

Thursday, October 23, 2014 01:10 PM

Provectus Biopharmaceuticals, a Knoxville, Tenn.-based development-stage oncology and dermatology biopharmaceutical company, has retained INC Research, a Raleigh, N.C.-based global CRO, to conduct an FDA due diligence audit of its regulatory documents for PH-10 and PV-10.

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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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The CenterWatch Monthly

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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The CenterWatch Monthly

September

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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