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2014 Drug Approvals: Speeding Novel Drugs to the Patients Who Need Them

Wednesday, December 17, 2014 03:15 PM

Margaret A. Hamburg, M.D., commissioner of the FDA, spoke about 2014 drug approval data on the FDA’s official blog FDAVoice.

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MMG names Helen West president, Ann Kottcamp as COO

Wednesday, December 17, 2014 12:51 PM

MMG, a Rockville, Md.-based global, full-service patient recruitment group, a Ketchum company and part of the Omnicom Group, has appointed Helen West president, effective Jan. 1. She succeeds John Benbrook, who is departing MMG to become CEO of a Pennsylvania-based publishing company.

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FDA announces Pharmacy Compounding Advisory Committee members

Wednesday, December 17, 2014 12:29 PM

The FDA has announced the membership of the Pharmacy Compounding Advisory Committee. The committee is comprised of 14 members—12 voting and two non-voting—who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.

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PPD, ERT partner to enhance drug development

Wednesday, December 17, 2014 12:28 PM

Pharmaceutical Product Development (PPD), a global CRO based in Wilmington, N.C., and ERT, a Philadelphia, Pa.-based provider of patient safety and efficacy data collection solutions, have partnered to facilitate delivery of ERT’s comprehensive solutions for patient safety and efficacy endpoint data collection to help biopharmaceutical clients conduct clinical trials in a more efficient and cost-effective manner.

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Infraredx, Massachusetts General Hospital collaborate on cardiovascular imaging devices

Wednesday, December 17, 2014 12:26 PM

Infraredx, a Burlington, Mass.-based cardiovascular imaging company, is collaborating with Massachusetts General Hospital (MGH) and coronary imaging researcher Gary Tearney, M.D., Ph.D., professor of pathology at Harvard Medical School, Mike and Sue Hazard Family MGH Research Scholar and founder of the Tearney Lab at the Wellman Center for Photomedicine at MGH. The multi-year collaboration will focus on research and development of new and combination technologies that aim to provide enhanced information about coronary disease in patients.

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CRF Health partners with EuroQol to become a preferred eCOA provider

Wednesday, December 17, 2014 12:21 PM

CRF Health, a global provider of eCOA solutions for the life sciences industry based in Plymouth Meeting, Pa., has inked an agreement with EuroQol to launch the EQ-5D web system on its TrialMax Web software platform. CRF Health has become the first eCOA provider to be granted permission to host the EQ-5D web version for use in clinical trials. CRF Health now is uniquely positioned to provide a single solution for eCOA that combines the benefits of EQ-5D to make data collection faster and optimize the valuation of health outcomes. 

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Curie-Cancer, GamaMabs Pharma renew research partnership

Wednesday, December 17, 2014 12:17 PM

Curie-Cancer, the London-based body responsible for developing Institut Curie’s industry partnership activities, and GamaMabs Pharma, a French biotechnology company developing monoclonal antibodies for cancer, have extended their partnership to develop the 3C23K antibody for the treatment of gynecological cancers.

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ClinicalRM tests convalescent plasma therapy for Ebola treatment

Monday, December 15, 2014 01:24 PM

Clinical Research Management (ClinicalRM), a full-service CRO with headquarters in Ohio, has announced that the clinical trial evaluating the safety and efficacy of Ebola convalescent plasma (ECP) for the treatment of Ebola virus disease (EVD) in Liberia has commenced. The first donor survivors at the ELWA Hospital 2 unit in Monrovia, Liberia have undergone plasmapheresis. The donated convalescent plasma was transferred to a Liberian patient with EVD in an effort to help them combat this disease. The ClinicalRM trial is being funded through a grant from the Bill & Melinda Gates Foundation.

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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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Parexel ClinPhone RTSM named interactive response technology leader

Monday, December 15, 2014 12:48 PM

Parexel International, a global biopharmaceutical services provider, has announced that its randomization and trial supply management (RTSM) services, ClinPhone RTSM, ranked as the leader of Interactive Response Technology (IRT), according to a new global survey of pharmaceutical and biotechnology companies by Industry Standard Research (ISR). ClinPhone RTSM also was cited as the most preferred and widely used IRT solution.

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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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