United States

FDA approves GSK's four-strain seasonal influenza vaccine

Monday, December 17, 2012 04:28 PM

The FDA has approved GlaxoSmithKline’s Fluarix Quadrivalent (influenza virus vaccine) for the immunization of adults and children (three years and older) to help prevent disease caused by seasonal influenza virus subtypes A and B contained in the vaccine.

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Promedior opens new office and labs in Lexington, Mass.

Monday, December 17, 2012 03:34 PM

Promedior, a clinical stage biotechnology company focused on fibrosis, is opening its new office and laboratory space at 101 Hartwell Avenue, Lexington, Mass.

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23andMe raises more than $50M in new financing

Monday, December 17, 2012 02:37 PM

23andMe, a personal genetics company based in Mountain View, Calif., has raised more than $50 million in a Series D financing. Participants in the financing include Yuri Milner, a new investor, as well as existing investors Sergey Brin, 23andMe CEO Anne Wojcicki, New Enterprise Associates, Google Ventures and MPM Capital. This investment will help the company achieve its growth goal of one million customers.

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Naurex completes $38M Series B financing

Monday, December 17, 2012 12:03 PM

Naurex, an Evanston, Ill.-based clinical-stage company focused on developing treatments for CNS disorders, has completed a $38 million Series B financing led by new investor Baxter Ventures. 

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The Medicines Company to acquire Incline Therapeutics

Friday, December 14, 2012 10:14 AM

The Medicines Company, a medical solutions company based in Parsippany, N.J., has agreed to acquire Incline Therapeutics, hospital-focused specialty pharmaceutical company based in Redwood City, Calif.

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Pernix Therapeutics to acquire Somaxon Pharmaceuticals

Wednesday, December 12, 2012 09:22 AM

Pernix Therapeutics, a specialty pharmaceutical company based in The Woodlands, Texas, has entered into a definitive merger agreement to acquire Somaxon Pharmaceuticals, a San Diego-based specialty pharmaceutical company, in a stock-for-stock transaction with a total equity value of $25 million.

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Biogen Idec, Isis collaborate on antisense programs for neurological disorders

Monday, December 10, 2012 11:54 AM

Weston, Mass.-based Biogen Idec and Isis Pharmaceuticals of Carlsbad, Calif., have entered into a global collaboration agreement to discover and develop antisense drugs against three undisclosed targets to treat neurological or neuromuscular disorders. Biogen Idec and Isis are already collaborating on antisense drugs to treat spinal muscular atrophy and myotonic dystrophy type 1 under previously established collaborations.

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DIA begins transition to new executive leadership

Monday, December 10, 2012 09:12 AM

DIA, a neutral, global, nonprofit association that provides knowledge resources across the full spectrum of medical product development, announced that Paul Pomerantz, worldwide executive director of DIA, will be leaving effective March 3, 2013, to assume the position of CEO for the American Society of Anesthesiologists.

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NanoString touts positive results from study of PAM50-based breast cancer assay

Friday, December 7, 2012 03:01 PM

NanoString Technologies, a Seattle, Wash.-based privately held provider of life science tools for translational research and developer of molecular diagnostic products, released positive results from the second clinical validation study of its in vitro diagnostic breast cancer assay based on the PAM50 gene expression signature.

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FDA grants Biodel orphan drug designation for rare insulin disease

Friday, December 7, 2012 02:34 PM

The FDA has given special designation to glucagon, developed by specialty pharmaceutical company Biodel,for patients with congenital hyperinsulinism (CHI), or abnormally low blood sugar—a rare disorder that affects children.

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CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

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The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

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December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

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