Global News

Spinifex Pharmaceuticals to be acquired by Novartis

Monday, June 29, 2015 09:22 AM

Novartis International has agreed to acquire Spinifex Pharmaceuticals, a company focused on the development of new drugs for the treatment of chronic pain based in Stamford, Conn., and Melbourne, Australia, for an upfront cash consideration of $200 million plus undisclosed clinical development and regulatory milestone payments.

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The critical elements of study startup

Monday, June 29, 2015 08:00 AM

The study startup phase has the lowest performance scores and the greatest variation in performance than any other stage of clinical trials.

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PRA launches Predictivv platform for global studies

Friday, June 26, 2015 09:28 AM

Global CRO PRA Health Sciences has launched its Predictivv platform, the beginning of an entirely new approach on the role technology will play in the future of clinical development. The Predictivv platform will be a fully integrated solution for designing, planning and optimizing the management of global clinical studies. Designed around a unified platform that harmonizes data, processes and people across every aspect of a clinical study, Predictivv will enable unprecedented adaptive intelligence and decision support for the ever-increasing complexities of the clinical development process.

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Illumina adds European headquarters in Cambridge, England

Friday, June 26, 2015 09:23 AM

Illumina, a San Diego-based provider of sequencing and array-based technologies, has signed a 20-year lease for a 155,000 square foot new and innovative scientific research building in Cambridge, England. The project will provide Illumina a collaborative environment and access to the highly skilled workforce in the dynamic research cluster anchored by Cambridge University.

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Parexel to cut 850 jobs

Friday, June 26, 2015 08:43 AM

Parexel International has updated its forward-looking guidance for the fourth quarter of Fiscal Year 2015 (ending June 30) and for the full Fiscal Year 2015. The company expects to restructure the company, cutting 850 positions.

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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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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

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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The CenterWatch Monthly

June

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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