Clinical Intelligence

Johnson & Johnson begins phase I clinical trial of Ebola vaccine regimen

Thursday, January 8, 2015 02:19 PM

Johnson & Johnson has begun a phase I, first-in-human clinical trial of a preventive Ebola vaccine in development at its Janssen Pharmaceutical Companies. The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Pediatrics. Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January.

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FDA grants Soligenix Fast Track designation for SGX301 for lymphoma

Thursday, January 8, 2015 02:12 PM

Soligenix, a late-stage biopharmaceutical company developing products that address unmet medical needs in the areas of inflammation, oncology and biodefense, has announced that its SGX301 (synthetic hypericin) development program for the first-line treatment of cutaneous T-cell lymphoma (CTCL) has received Fast Track designation from the FDA.

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The CenterWatch Monthly, January 2015

Monday, January 5, 2015 07:00 AM

U.S. watching EMA’s adaptive licensing pilot

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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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Anergis starts phase II trial with birch pollen allergy vaccine AllerT

Monday, December 15, 2014 08:00 AM

Anergis, a Swiss-based company developing proprietary ultra-fast allergy vaccines, has begun a phase II trial designed to finalize the dose selection for the phase III study of AllerT. AllerT is Anergis´ lead vaccine against birch pollen allergy that originated from the company´s proprietary Contiguous Overlapping Peptide (COP) platform. COPs are pharmaceutical-grade, long-peptide immunotherapeutics designed for an ultra-fast, safe and long-lasting treatment of allergy patients.

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Amgen initiates trial of Talimogene Laherparepvec and Merck's Keytruda

Thursday, December 11, 2014 01:46 PM

Amgen has initiated a trial of talimogene laherparepvec, an investigational oncolytic immunotherapy, in combination with an investigational use of Merck's FDA approved, anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with regionally or distantly metastatic melanoma. The trial has enrolled its first patient and will evaluate the combination of these two therapies in approximately 110 patients across 35 clinical trial sites in the U.S., Australia and Europe.

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Neurocrine Biosciences expands clinical pipeline

Thursday, December 11, 2014 01:12 PM

Neurocrine Biosciences has announced that NBI-77860, a proprietary corticotropin releasing factor 1 (CRF) receptor antagonist, has entered clinical trials for the treatment of classic congenital adrenal hyperplasia (CAH) a disease that affects approximately 20,000-30,000 people in the U.S. The company has successfully completed a pilot clinical trial in adults with classic CAH and is initiating an open-label, single ascending dose trial in approximately 15 adolescent females with classic CAH, the 1401 Study.

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FDA expands Gardasil 9 approval

Thursday, December 11, 2014 01:07 PM

The FDA has approved Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) for the prevention of certain diseases caused by nine types of Human Papillomavirus (HPV). Covering nine HPV types, five more HPV types than Gardasil (previously approved by the FDA), Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers.

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FDA approves Blincyto (Blinatumomab) for leukemia

Thursday, December 4, 2014 02:20 PM

The FDA has granted approval of Amgen’s Blincyto (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). This indication is approved under accelerated approval.

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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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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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