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FDA approves Avastin to treat aggressive and late-stage cervical cancer

Friday, August 15, 2014 12:43 PM

The FDA has approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.

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WIRB Copernicus Group

Juventas Therapeutics completes enrollment of phase I/II RETRO-HF trial

Friday, August 15, 2014 12:41 PM

Juventas Therapeutics, a private, clinical-stage company developing a drug-based approach to regenerative medicine, has successfully completed the phase I arm of the RETRO-HF clinical trial, and fully enrolled the phase II arm that is evaluating the safety and preliminary clinical efficacy for retrograde infusion of JVS-100 in patients with heart failure.

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Telik appoints new board of director members

Friday, August 15, 2014 12:19 PM

Telik, a clinical stage oncology drug development company based in California, which recently merged with MabVax Therapeutics in July, has appointed six new members of the board of directors to help guide the company and its management in developing an expanded product development pipeline post-merger.

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Peter Hirth joins Trovagene's scientific advisory board

Friday, August 15, 2014 10:34 AM

Trovagene, a California-based developer of cell-free molecular diagnostics, has hired K. Peter Hirth, Ph.D., who joins the company's scientific advisory board. A pioneer in the field of personalized medicine, Hirth led the organizations that developed both Sutent and Zelboraf; two successful targeted cancer therapeutics.

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Susan Dallabrida named to PharmaVOICE 100

Friday, August 15, 2014 09:25 AM

PHT has announced Susan Dallabrida, Ph.D., vice president of clinical science and consulting, is among this year’s PharmaVOICE 100 most inspiring professionals in the life sciences industries. Dallabrida is the 6th PHT executive to earn a place on the list. PHT is a provider of technologies used to collect patient-driven eData for clinical research.

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FDA approves new sleep drug Belsomra

Friday, August 15, 2014 09:17 AM

The FDA has approved Belsomra (suvorexant) tablets for use as needed to treat difficulty in falling and staying asleep (insomnia).

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Group of 19 institutional investors seeks support for biosimilars from top biopharma companies

Thursday, August 14, 2014 02:34 PM

Don’t bad mouth biosimilars—they are needed to help hold down skyrocketing drug costs.

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Biocryst Pharmaceuticals receives NIAID funds for hemorrhagic fever viruses

Thursday, August 14, 2014 11:44 AM

BioCryst Pharmaceuticals, based in Research Triangle Park, N.C., has announced the National Institute of Allergy and Infectious Diseases (NIAID) has exercised additional options to conduct phase I clinical human safety trials of an intramuscular formulation of BCX4430.

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ZAI Lab, Sanofi ink agreement for chronic respiratory disease compounds

Thursday, August 14, 2014 11:43 AM

ZAI Lab, a biotech company in China, has entered into a global licensing agreement with Sanofi for two novel compounds for the potential treatment of chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), asthma and idiopathic pulmonary fibrosis (IPF). The compounds were discovered by Sanofi and currently are in preclinical stage.

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Almac Group to expand, create 348 new jobs

Thursday, August 14, 2014 11:41 AM

The Almac Group is investing over $90.1 million and creating 348 jobs over the next five years. Almac Group provides services including drug discovery, diagnostics, R&D, the manufacture of active pharmaceutical ingredients, formulation development and clinical trials.

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CenterWatch Drugs in Clinical Trials
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August 25

Verizon Communications enters clinical trial space with technology, network, and cloud and data services

Sponsors look to the power of genomic profiling to screen, enroll patients in trials for targeted therapies

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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