Global News

The CenterWatch Monthly, August 2014

Friday, August 1, 2014 01:46 PM

Reality of costs and impact rain on Sunshine Act

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WIRB Copernicus Group

MGC Diagnostics completes acquisition of MediSoft

Friday, August 1, 2014 01:43 PM

MGC Diagnostics, a global medical technologies company, has completed its acquisition of MediSoft, a privately held manufacturer of cardiorespiratory diagnostic products based in Belgium.

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ACRO backs COMPETE Act to expand R&D tax credit

Thursday, July 31, 2014 02:07 PM

On the eve of Congress’ summer departure, an R&D tax credit bill called the COMPETE Act was introduced this morning that would make the R&D tax credit permanent, increase the credit rate to 25% of qualifying research investments and enable investors in small research companies to claim the credit.

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FDA expands approved use of Imbruvica for chronic lymphocytic leukemia

Thursday, July 31, 2014 01:55 PM

The FDA has expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a Breakthrough Therapy Designation for this use.

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Noxxon initiates phase IIa study of Anti-Hepcidin Spiegelmer Lexaptepid Pegol

Thursday, July 31, 2014 01:52 PM

Noxxon Pharma, a biopharmaceutical company developing proprietary therapeutics called Spiegelmers, has treated the first patient with its anti-hepcidin Spiegelmer lexaptepid pegol (NOX-H94) in a phase IIa proof-of-concept clinical trial to treat erythropoietin (EPO) hyporesponsive anemia in dialysis patients.

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INC Research appoints Jan Schreur senior vice president, human resources

Thursday, July 31, 2014 01:22 PM

INC Research, a global phase I to IV CRO, has appointed Jan Schreur as the company's senior vice president, human resources. Schreur brings nearly 30 years of progressive human resources experience to the role, including senior leadership positions at global biopharmaceutical organizations.

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AstraZeneca to acquire Almirall’s respiratory franchise

Thursday, July 31, 2014 12:39 PM

Barcelona-based Almirall has entered an agreement to transfer its respiratory franchise to AstraZeneca for an initial consideration of $875 million on completion and up to $1.22 billion in development, launch and sales-related milestones. AZ also has agreed to make various sales-related payments.

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CDC awards Leidos $44 million contract

Thursday, July 31, 2014 12:37 PM

Leidos, a national security, health and engineering solutions company, was awarded a prime task order by the Centers for Disease Control and Prevention (CDC) to provide development, support and maintenance of the National Healthcare Safety Network (NHSN).

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Pfizer to buy Baxter’s commercial vaccines business for $635M

Thursday, July 31, 2014 12:35 PM

Baxter International will sell its two commercially marketed vaccines and related production facilities to Pfizer for $635 million in cash.

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Incyte, Genentech ink clinical trial agreement for cancer immunotherapies

Thursday, July 31, 2014 12:33 PM

Incyte has entered into a clinical trial agreement with Genentech to evaluate the safety, tolerability and preliminary efficacy of Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360, in combination with Genentech's PD-L1 immune checkpoint inhibitor, MPDL3280A, in patients with non-small cell lung cancer (NSCLC).

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July 28

WCG acquires Alliance Biosciences to expand its biosafety oversight capabilities, ensure compliance

Facilitated review meetings for protocol design catching on, decreasing amendments, complexity

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The CenterWatch Monthly

August

Reality of costs and impact rain on Sunshine Act
Concerns mount over compliance burden on CROs, sponsors, unanticipated consequences for research

Cloud computing expanding into all areas of clinical trial conduct
Benefits outweigh the complexities, challenges of finding right vendors

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The CenterWatch Monthly

July

IRB market consolidating rapidly
Private equity driving a new commercial ethical review landscape

Lessons learned from medical device trials
Smaller, faster, more flexible trials hold important insights for pharmaceutical innovation

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