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Margaret A. Hamburg appointed Institute of Medicine foreign secretary

Friday, April 10, 2015 11:29 AM

Margaret A. Hamburg, former commissioner of the FDA, has been appointed as the next foreign secretary of the Institute of Medicine, the health arm of the National Academy of Sciences. In this part-time position, Hamburg will work as a senior adviser on international matters to the IOM president and council and as liaison to foreign academies of medicine and science.

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Quest Diagnostics

FDA grants Priority Review to lifitegrast NDA for dry eye disease in adults

Thursday, April 9, 2015 02:20 PM

The FDA has accepted for filing Shire's NDA for lifitegrast and granted a Priority Review designation. Lifitegrast is an investigational treatment for dry eye disease in adults and, if approved, has the potential to be the first treatment indicated to address both signs and symptoms of the disease. The FDA is expected to provide a decision on October 25, based on the Prescription Drug User Fee Act V action date.

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EnteroMedics appoints Scott A. Shikora EVP of medical affairs, CMO

Thursday, April 9, 2015 02:09 PM

EnteroMedics, a developer of medical devices using neuroblocking therapy to treat obesity, metabolic diseases and other gastrointestinal disorders, has named Scott A. Shikora, M.D., FACS, executive vice president of medical affairs and chief medical officer of EnteroMedics, effective June 1. He will lead the company's medical affairs, clinical and regulatory functions.

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Greenphire opens new global headquarters

Thursday, April 9, 2015 01:49 PM

Greenphire, a provider of payment technology for the clinical trials industry, has moved its operations to new headquarters in King of Prussia, Pa. The move quadruples the company's office space in the region and supports Greenphire's ongoing growth strategy that will see the business rapidly scale its operational infrastructure to support its growing global client base.

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Sanford-Burnham, Daiichi Sankyo ink agreement

Thursday, April 9, 2015 01:48 PM

Sanford-Burnham Medical Research Institute, a nonprofit, independent institute that employs more than 1,000 scientists and staff in San Diego, Calif., and Orlando, Fla., has signed a licensing agreement to further develop a first-in-class small molecule with Daiichi Sankyo for the treatment of cardiovascular-metabolic disease.

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DARPA awards Inovio $45M Ebola program grant

Thursday, April 9, 2015 01:43 PM

Inovio Pharmaceuticals, based in Plymouth Meeting, Pa., has been awarded a $45 million grant from the Defense Advanced Research Projects Agency (DARPA) to lead a collaborative team to develop multiple treatment and prevention approaches against Ebola.

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Roche becomes majority shareholder in Foundation Medicine

Thursday, April 9, 2015 01:41 PM

Roche has become a majority shareholder of Foundation Medicine, a molecular information company based in Cambridge, Mass. Roche purchased approximately 15.6 million shares of common stock through a tender offer from Foundation Medicine stockholders at a price of $50 per share.

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Mylan proposes to acquire Perrigo for $205 per share

Thursday, April 9, 2015 01:36 PM

Mylan, a global generics and specialty pharmaceutical company, has made a proposal to acquire Perrigo, an Irish international manufacturer of over-the-counter pharmaceuticals, in a cash-and-stock transaction.

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Rhythm initiates phase IIb clinical trial of relamorelin for diabetic gastroparesis

Thursday, April 9, 2015 12:59 PM

Rhythm, a biopharmaceutical company, and Actavis, a global pharmaceutical company, have initiated a phase IIb clinical trial assessing the efficacy and safety of relamorelin (RM-131), Rhythm's ghrelin agonist, for the treatment of gastroparesis in patients with type 1 and type 2 diabetes. Ghrelin is a peptide hormone produced in the stomach that stimulates gastrointestinal (GI) motility. Actavis has an exclusive option to acquire Rhythm's wholly owned subsidiary, Rhythm Pharmaceuticals, upon the completion of the phase IIb study.

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Celtaxsys to begin phase II trial of oral CTX-4430 for acne vulgaris

Thursday, April 9, 2015 12:48 PM

Atlanta-based pharmaceutical company Celtaxsys has received regulatory clearance to commence a phase II trial for its flagship compound, CTX-4430, in patients with moderate to severe facial acne vulgaris. This approval triggers site engagement to screen and enroll appropriate patients with acne.

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CWWeekly

April 20

Christie Clinic, PMG Research's 12th clinical research site, expands its geographic reach north to Illinois

Clinipace acquires Accovion to expand European presence, following an infusion of equity that could lead to more deals

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The CenterWatch Monthly

April

PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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