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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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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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Immatics, BioNTech advance personalized cancer vaccines into clinical trials

Thursday, October 16, 2014 12:00 PM

BioNTech and immatics biotechnologies are moving a novel concept of fully personalized therapeutic cancer vaccines, Glioma Actively Personalized VAccine Consortium (GAPVAC), into the clinic. The German national authority, the Paul-Ehrlich-Institute (PEI), has approved the start of a phase I/II study, GAPVAC-101, which applies for the first time the concept of treating glioblastoma patients based on drugs designed and manufactured for each patient individually according to specific characteristics of their tumor and immune system.

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Novartis publishes CTL019 data for acute lymphoblastic leukemia

Thursday, October 16, 2014 11:55 AM

Novartis and the University of Pennsylvania's Perelman School of Medicine have announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine (NEJM) evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor (CAR) therapy CTL019.

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FDA approves Ofev to treat idiopathic pulmonary fibrosis

Thursday, October 16, 2014 11:49 AM

The FDA has approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

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University of Maryland, Malian Ministry begin human trials of Ebola vaccine in West Africa

Monday, October 13, 2014 09:16 AM

The Center for Vaccine Development (CVD), in conjunction with its sister institution, the Center for Vaccine Development of Mali (CVD-Mali) and the Ministry of Health of Mali, have begun a clinical trial in health care workers (and other front-line workers) to evaluate a promising experimental Ebola vaccine.

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October 27

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

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CROs driving changes in patient recruitment
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