Eli Lilly

FDA expands approved use of Cyramza to treat aggressive non-small cell lung cancer

Monday, December 15, 2014 12:50 PM

The FDA has expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).

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Illinois Biotechnology Industry Organization adds to board of directors

Thursday, December 11, 2014 10:51 AM

The Illinois Biotechnology Industry Organization (iBIO) has elected several new additions to its board of directors. The new board members include Daniel Brennan of Lundbeck U.S., Jamie Oldani of Eli Lilly, Susanne Resatz of Vetter Development Services USA and Geeta Vemuri of Baxter Ventures.

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Global policymakers urged to accelerate cancer research, biomedical discovery

Monday, December 8, 2014 01:09 PM

Accelerating the delivery of promising new treatments to patients must be an international priority, according to the National Patient Advocate Foundation (NPAF), a Wash. D.C.-based nonprofit organization providing the patient's voice in improving access to quality cancer care.

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Zosano Pharma, Eli Lilly to develop osteoporosis treatment

Wednesday, December 3, 2014 12:58 PM

Zosano Pharma, based in Fremont, Calif., and Eli Lilly have entered into an exclusive agreement to develop ZP-PTH, Zosano's proprietary formulation of parathyroid hormone 1-34 (PTH) using Zosano's microneedle patch system for treating osteoporosis patients, globally. Zosano has completed a phase II study of ZP-PTH for the treatment of severe osteoporosis and plans to conduct phase III development.

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CDISC, TransCelerate release new standards for diabetes, cardiovascular disease

Wednesday, November 26, 2014 11:45 AM

The Clinical Data Interchange Standards Consortium (CDISC), a global nonprofit, and King of Prussia, Pa.-based nonprofit TransCelerate BioPharma have made available therapeutic area standards for diabetes and cardiovascular (CV) disease areas through the Coalition for Accelerating Standards and Therapies (CFAST), a joint initiative of CDISC and the Critical Path Institute (C-Path).

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Global oncologists share insights into cancer immunology

Monday, November 24, 2014 08:00 AM

Cancer immunotherapy has become one of the hottest fields of clinical research in decades.

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Edward Lanphier elected chairman of the Alliance for Regenerative Medicine

Thursday, November 13, 2014 02:15 PM

Sangamo BioSciences has announced that Edward Lanphier, the company's president and CEO, has been elected as the next chairman of the Alliance for Regenerative Medicine (ARM). Wash. D.C.-based ARM is an international organization that represents and supports industry, clinical institutions, patient advocates and other stakeholders in the development of safe and effective gene and cell therapies. Lanphier succeeds Geoff MacKay, president and CEO of Organogenesis, who will complete his two-year term as chairman on Dec. 31.

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Cloud Pharmaceuticals ratifies board of directors

Friday, November 7, 2014 01:42 PM

Cloud Pharmaceuticals, a therapeutics company focused on cloud-based drug design and development, has ratified its board of directors. Members of the board include Cloud Pharmaceuticals chairman and CEO Ed Addison, chief scientific officer Shahar Keinan, Ph.D., and chief information officer Lawrence Husick. Other members of the board include:

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Spark Therapeutics receives FDA Breakthrough Therapy designation for SPK-RPE65

Friday, November 7, 2014 01:29 PM

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has announced that its lead product candidate, SPK-RPE65, has received Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where initial clinical evidence demonstrates a significant improvement over existing therapies. SPK-RPE65 targets a group of blinding conditions known as inherited retinal dystrophies (IRDs) caused by autosomal recessive mutations in the RPE65 gene, and for which there currently is no pharmacologic treatment available.

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Novartis to sell influenza vaccines business to CSL for $275M

Monday, November 3, 2014 02:39 PM

Novartis has agreed to divest its influenza vaccines business to CSL for $275 million. This transaction requires regulatory approvals and is expected to close in the second half of 2015.

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CWWeekly

December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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The CenterWatch Monthly

December

Growing adoption of feasibility review committees
Early reports cite fewer amendments, improved cycle time

AMCs vying to better compete for industry trials
Working to conquer study start-up delays, IRB review process

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The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

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