Global News

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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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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EFPIA hires Joe Jimenez, CEO of Novartis, as new president

Thursday, December 11, 2014 12:06 PM

EFPIA has appointed Joe Jimenez, CEO of Novartis, as its new president. He will work alongside Dr. Stefan Oschmann, CEO Pharma of Merck, and Marc de Garidel, chairman and CEO of Ipsen, who have been appointed as vice presidents by the board.

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Report: Return on pharmaceutical R&D on the rise

Thursday, December 11, 2014 11:57 AM

The rate of return on pharmaceutical R&D is on the rise for the first time since 2010. Since 2013, there has been an increase in R&D returns, from 5.1% to 5.5%, according to a study by Deloitte, a U.K. professional services firm.

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Ono Pharmaceutical, Bristol-Myers Squibb, Kyowa Hakko Kirin partner

Thursday, December 11, 2014 11:56 AM

Bristol-Myers Squibb and Japan-based companies Ono Pharmaceutical and Kyowa Hakko Kirin have entered into a clinical trial collaboration agreement to conduct a phase I combination study with Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor, and mogamulizumab, an anti-CCR4 antibody. The study, which will be conducted in Japan, will focus on evaluating the safety, tolerability and anti-tumor activity of combining Opdivo and mogamulizumab as a potential treatment option for patients with advanced or metastatic solid tumors.

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NIH initiates Centers Without Walls, awards $5.9M in funding

Thursday, December 11, 2014 11:54 AM

Nine groups of scientists will receive funding totaling $5.9 million in 2014 to work together on increasing the understanding of sudden unexpected death in epilepsy (SUDEP), the leading cause of death from epilepsy. The consortium becomes the second Center Without Walls, an initiative to speed the pace of research on difficult problems in epilepsy by promoting collaborative research. The U.S. National Institute of Neurological Disorders and Stroke (NINDS), part of the NIH, funds this initiative.

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PPMD calls for greater transparency, accountability of FDA patient engagement efforts

Wednesday, December 10, 2014 01:16 PM

Parent Project Muscular Dystrophy (PPMD), an advocacy organization working to end Duchenne muscular dystrophy, is urging Congress to build upon gains in recent years to further strengthen and enhance programs to ensure the patient voice is heeded during the drug development process. PPMD is advocating for provisions within the 21st Century Cures Initiatives focused on measuring how the agency is or is not using new patient engagement tools.

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Society for Clinical Research Sites, Clinical Ink partner

Wednesday, December 10, 2014 01:14 PM

The Society for Clinical Research Sites (SCRS), an Ellicott City, Md.-based global trade organization representing the interests of clinical research sites, has announced a two-year collaboration with Clinical Ink, a Winston-Salem, N.C.-based provider of eSource solutions for clinical trials. Clinical Ink will participate as a Global Impact Partner (GIP).

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TrialScope updates PharmaCM, now supports European results reporting

Wednesday, December 10, 2014 01:09 PM

TrialScope, a Jersey City, N.J.-based global provider of clinical trial transparency and compliance solutions, has made available the latest release of the PharmaCM platform (v.2.2) that automates and manages clinical trial results reporting via the EMA's European Clinical Trials Database (EudraCT).

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Merck to acquire Cubist Pharmaceuticals for $9.5B to expand hospital acute care pipeline

Monday, December 8, 2014 03:29 PM

Shying away from mega-mergers to instead focus on mid-sized drug makers that complement its product pipeline, Merck said this morning it will acquire Cubist Pharmaceuticals for $9.5 billion, including $1.1 billion in debt.

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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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