Theorem Clinical Research

United States

FDA accepts Actavis’ sNDA for Saphris for bipolar I disorder in pediatric patients

Thursday, November 13, 2014 02:35 PM

The FDA has accepted for filing Actavis' supplemental New Drug Application (sNDA) for Saphris (asenapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age. Actavis' sNDA for Saphris has been granted priority review status by the FDA.

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Quest Diagnostics

FDA approves sNDAs for Invega Sustenna for schizoaffective disorder

Thursday, November 13, 2014 02:22 PM

The FDA has approved Janssen Pharmaceutical's supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. The symptoms of schizoaffective disorder are complex and, without treatment, disabling. The FDA approved these sNDAs under Priority Review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

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UCB to sell generics business to private equity firms Advent, Avista Capital for $1.525 billion

Monday, November 10, 2014 12:26 PM

Advent International and Avista Capital Partners, two private equity firms with a strong healthcare focus, have agreed to acquire UCB’s U.S. specialty generics subsidiary, Kremers Urban Pharmaceuticals (KU). UCB is a multinational biopharmaceutical manufacturing company headquartered in Brussels, Belgium.

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Medidata, PPD partner to offer new approach to risk-based monitoring

Monday, November 10, 2014 12:22 PM

Medidata, a New York-based global provider of cloud-based solutions for clinical research in life sciences, and Pharmaceutical Product Development (PPD), a Wilmington, N.C.-based global CRO, are expanding their partnership to provide the life science industry with a more comprehensive approach to risk-based monitoring (RBM)—aimed at conducting drug development more intelligently, more quickly and more cost-effectively.

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Idera Pharmaceuticals, Parent Project Muscular Dystrophy collaborate

Monday, November 10, 2014 12:20 PM

Idera Pharmaceuticals, a Cambridge, Mass.-based clinical-stage biopharmaceutical company, and nonprofit organization Parent Project Muscular Dystrophy (PPMD), based in Hackensack, N.J., are collaborating to advance Idera's proprietary Toll-like receptor (TLR) technology for the treatment of Duchenne muscular dystrophy.

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Charles River, CHDI Foundation extend Huntington's disease collaboration

Monday, November 10, 2014 12:18 PM

CRO Charles River International, based in Wilmington, Mass., and the CHDI Foundation, a U.S., privately-funded, nonprofit, biomedical research organization, have extended an ongoing collaboration for an additional five years through 2019. The collaboration, which began in 2005, is focused on discovering novel drugs for Huntington's disease.

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Datatrak expands offices into Chicago

Monday, November 10, 2014 12:16 PM

Datatrak International, a developer of cloud-based, unified eClinical technologies for the clinical trials industry, will expand office locations to include downtown Chicago in early 2015.

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Stephen T. Sonis joins PlasmaTech Biopharmaceuticals' scientific advisory board

Friday, November 7, 2014 02:07 PM

PlasmaTech Biopharmaceuticals, a biopharmaceutical company advancing patient care in critical areas, has announced that Stephen T. Sonis, DMD, DMSc, has joined its scientific advisory board (SAB). A world-renowned expert in the clinical treatment and research of cancer-related mucosal toxicities, Sonis has collaborated with management in recent years on advancing the company's clinical efforts of its oral mucositis treatment, MuGard.

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Bill & Melinda Gates Foundation awards PATH $156M for malaria research

Friday, November 7, 2014 01:23 PM

The Bill & Melinda Gates Foundation, of Seattle, Wash., has awarded $156 million to PATH, a Seattle-based international nonprofit organization, to support the PATH Malaria Vaccine Initiative (MVI) in building new vaccines that will interrupt the cycle of malaria parasite transmission and help realize the "accelerating to zero" agenda. Such vaccines would ensure parasite reintroduction is prevented by providing what could be called an "immunological bed net."

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FDA issues response letter for Aeterna Zentaris' Macrilen NDA

Friday, November 7, 2014 12:58 PM

Aeterna Zentaris, is a specialty biopharmaceutical company, has received a complete response letter (CRL) from the FDA for its NDA for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.

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