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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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PhotoxAir reduces airborne bacteria in clinical trials

Thursday, October 9, 2014 11:54 AM

Wake Forest Baptist Medical Center, a North Carolina-based medical center, has announced that studies have conclusively demonstrated that the PhotoxAir purification system significantly reduced airborne bacteria in clinical trials conducted in an emergency department setting.

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Bristol-Myers Squibb withdraws NDA with FDA for asunaprevir

Thursday, October 9, 2014 11:51 AM

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which currently is being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

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Chimerix receives Emergency Investigational NDA for Ebola

Thursday, October 9, 2014 11:45 AM

Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the FDA.

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Noven receives FDA new indication approval for Minivelle

Thursday, October 2, 2014 02:01 PM

Noven Pharmaceuticals has announced that the FDA has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes. With this new approval, women who are using Minivelle to treat their VMS symptoms have the benefit of also helping to prevent osteoporosis.

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