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Obama outlines his Precision Medicine Initiative

Friday, January 30, 2015 12:31 PM

Building on President Obama’s announcement in his State of the Union Address, the administration is unveiling details about the Precision Medicine Initiative, a new research effort to revolutionize how to improve health and treat disease.

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U.K. announces $21M investment in stratified medicine

Friday, January 30, 2015 12:29 PM

Minister for Life Sciences George Freeman has announced a further $20.6 million investment in stratified medicine collaborations funded by the Medical Research Council (MRC). Four new awards bring the total of stratified medicine consortia funded by the MRC to 13, with investments totaling over $21 million—part of the government’s $195.4 million commitment to stratified medicine set out in the U.K. life sciences strategy.

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AstraZeneca collaborates to use CRISPR technology

Friday, January 30, 2015 12:27 PM

AstraZeneca has announced four research collaborations aimed at harnessing the power of CRISPR, a pioneering genome-editing technique, across its entire discovery platform in the company’s key therapeutic areas. The four research collaborations are with the Wellcome Trust Sanger Institute, Cambridge, U.K.; the Innovative Genomics Initiative, California; Thermo Fisher Scientific, Waltham, Mass.; and the Broad Institute/Whitehead Institute, Cambridge, Mass. The technology will allow AZ to identify and validate new drug targets in preclinical models that closely resemble human disease.

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Astellas Pharma, Immunomic Therapeutics collaborate

Friday, January 30, 2015 12:25 PM

Immunomic Therapeutics, a company developing next-generation vaccines based on the LAMP-vax platform headquartered in Hershey, Pa., and Astellas Pharma of Tokyo have entered into an exclusive license agreement for Japan to develop and commercialize JRC2-LAMP-vax, Immunomic Therapeutics' vaccine designed to treat allergies induced by Japanese red cedar pollen. The companies expect to initiate a phase I trial of JRC2-LAMP-vax in Japan as soon as it is ready.

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Investigator training efficiencies highlighted in new CTTI GCP recommendations

Friday, January 30, 2015 12:14 PM

The Clinical Trials Transformation Initiative (CTTI), based in Durham, N.C., has announced recommendations to streamline Good Clinical Practice (GCP) training of investigators who participate in clinical trials. GCP is an international standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials.

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Shire's SHP609 receives FDA Fast Track designation

Thursday, January 29, 2015 01:27 PM

The FDA has granted Fast Track designation for Shire’s SHP609 (idursulfase-IT; also known as HGT-2310) for the treatment of neurocognitive decline associated with Hunter syndrome (mucopolysaccharidosis II or MPSII).

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FDA approves Natpara for blood calcium levels related to hypoparathyroidism

Thursday, January 29, 2015 01:15 PM

The FDA has approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the U.S.

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Inovio Pharmaceuticals appoints Mark Gelder vice president, clinical development

Thursday, January 29, 2015 01:09 PM

Inovio Pharmaceuticals has appointed Mark Stephen Gelder, M.D., as vice president, clinical development. Gelder will be responsible for planning and executing Inovio's clinical development strategy for its immunotherapies against human papillomavirus (HPV)-caused cervical cancer and dysplasia. He will report to Dr. Mark Bagarazzi, Inovio's chief medical officer.

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Amerita acquires Infusionrx

Thursday, January 29, 2015 12:40 PM

Amerita, an Irvine, Calif.-based, wholly owned subsidiary of institutional pharmacy services company PharMerica, has completed the acquisition of Coastal Pharmaceutical Services company InfusionRx, based in Oxnard, Calif. Financial terms of the transaction have not been disclosed.

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Regulatory update on GSK-Novartis three-part transaction

Thursday, January 29, 2015 12:25 PM

GlaxoSmithKline has received clearance from the European Commission (E.C.) of its proposed three-part transaction with Novartis, which includes the acquisition of Novartis’s vaccines business (excluding influenza vaccines), the creation of a consumer healthcare joint venture between GSK and Novartis and the divestment to Novartis of GSK’s marketed oncology portfolio, related R&D activities and rights to two pipeline AKT inhibitors.

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CenterWatch Drugs in Clinical Trials
CWWeekly

January 26

2015 CRO outlook: M&As, IPOs, strategic partnerships and increased eClinical outsourcing expected to continue

IOM, industry stakeholders propose standards, guidelines for open sharing of clinical trial data

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The CenterWatch Monthly

January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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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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