Global News

FORUM Pharmaceuticals receives FDA Fast Track for schizophrenia

Thursday, June 25, 2015 12:12 PM

The FDA has granted Fast Track designation to encenicline, FORUM Pharmaceuticals’ lead compound in development to treat cognitive impairment in schizophrenia. Encenicline is a novel alpha 7 agonist in phase III development by FORUM to treat cognitive impairment in schizophrenia and Alzheimer's disease. The company recently completed patient enrollment in its pivotal phase III COGNITIV SZ clinical trial program investigating the use of encenicline as a pro-cognitive therapy in patients with schizophrenia who are currently being treated with atypical antipsychotics.

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HHS announces innovation award winners

Thursday, June 25, 2015 12:05 PM

Department of Health and Human Services Secretary Sylvia M. Burwell has announced the seven winners of the 2015 HHS Innovates Awards. This annual award program, in its eighth round, recognizes creative solutions developed by HHS employees in response to some of the nation’s most challenging problems in health, health care and government. Winners this year reflected a number of collaborative innovation projects representing seven different operating divisions.

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DBV Technologies planning Viaskin Peanut global phase III trial in children

Thursday, June 25, 2015 11:11 AM

DBV Technologies, a clinical-stage specialty biopharmaceutical company, has announced the completion of its End-of-Phase II meeting with the FDA. The outcome of this meeting on the clinical development plan for Viaskin Peanut is consistent with the previously announced positive opinion of the Pediatric Committee of the EMA on Viaskin Peanut’s Pediatric Investigation Plan (PIP).

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Pfizer enrolls first patient in phase III sickle cell disease trial

Thursday, June 25, 2015 10:54 AM

Pfizer has announced that the first patient has been enrolled in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study—a phase III clinical trial assessing the efficacy and safety of rivipansel for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease who are 6 years of age or older.

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NeoStem finalizes name change to Caladrius Biosciences

Thursday, June 25, 2015 10:17 AM

Caladrius Biosciences, a cell therapy company with a late-stage clinical program for immuno-oncology, has finalized its corporate name change from NeoStem to Caladrius.

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Huntingdon Life Sciences, Harlan Laboratories to become Envigo

Wednesday, June 24, 2015 11:21 AM

Huntingdon Life Sciences (HLS) and Harlan Laboratories, a U.K. CRO, have announced that the combined companies will be called Envigo.

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Claritas Genomics, Genetic Alliance partner on patients’ results sharing

Wednesday, June 24, 2015 10:38 AM

Claritas Genomics, a Cambridge, Mass.-based genetic diagnostic laboratory, and Genetic Alliance, a nonprofit health advocacy organization based in Wash. D.C., announced a partnership to help patients and families find and participate in relevant research opportunities that will advance understanding of individual genetic disorders and development of new therapies.

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ASBM responds to Australia’s breaks with other regulators on biosimilar substitution

Wednesday, June 24, 2015 10:20 AM

The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.

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FDA, TransCelerate, INC Research to speak at 10th Annual Global Site Solutions Summit

Wednesday, June 24, 2015 10:11 AM

The Society for Clinical Research Sites (SCRS), a global trade organization representing the interests of clinical research sites, has announced an invigorated, solution-driven program for the 10th Annual Global Site Solutions Summit. The Summit will be Oct. 8-11, in Amelia Island, Fla. The annual meeting, which attracts investigators, site executives and industry executives from around the globe, is inclusive of interactive sessions, knowledge and best practice sharing, and networking opportunities, centered around the collaboration-focused theme “Better Together.”

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Juniper, OxSonics partner for cancer drug delivery platform

Wednesday, June 24, 2015 10:02 AM

Juniper Pharma Services, a contract development and manufacturing organization (CDMO) subsidiary of Juniper Pharmaceuticals, has entered into a long-term collaboration with OxSonics to support the development, scale-up and GMP manufacturing of OxSonics' proprietary "sono-sensitive particles." OxSonics was established in July 2013 to develop and commercialize therapeutic ultrasound advancements invented at the University of Oxford's Institute of Biomedical Engineering.

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Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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