DIA Biosimilars 2013

Global News

Theorem Clinical Research names Joseph Sgherza head of infectious diseases

Tuesday, October 1, 2013 09:44 AM

Global CRO Theorem Clinical Research has named Joseph Sgherza vice president of biopharmaceutical development for its infectious disease franchise. Sgherza has 24 years in the pharmaceutical, biotech and CRO industries.

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Cenduit: Now with Patient Reminders

The CenterWatch Monthly, October 2013

Tuesday, October 1, 2013 09:00 AM

New growth and decline in Asia clinical trials

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CRF Health – eCOA Forum

Lundbeck simplifies and restructures, 200 jobs to be cut

Monday, September 30, 2013 03:40 PM

Lundbeck, a global pharmaceutical company specialized in brain diseases, has simplified its commercial structure, increased alignment across countries and improved competencies and investments in market access as a result of its Fit-for-the-Future program.

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GlaxoSmithKline sells brands, plant to Aspen Group

Monday, September 30, 2013 02:50 PM

GlaxoSmithKline has reached agreement to sell its thrombosis brands, Arixtra and Fraxiparine, and the Notre-Dame de Bondeville (NDB) manufacturing site to the Aspen Group, a South African pharmaceuticals company, for $1.13 billion in cash, of which $161.9 million relates to inventory. 

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Life Technologies launches EZQC Online

Monday, September 30, 2013 02:46 PM

Life Technologies, a global biotechnology company, has launched EZQC Online, a web-based tool for quality control management in molecular diagnostic labs. EZQC Online contains three modules: a guidance tool for initial validation and verification of molecular tests, a tool to help labs meet CLIA standards for calibration verifications and a tool for ongoing quality control monitoring that provides an opportunity for peer-to-peer comparisons.

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Gliknik, Pfizer enter autoimmune disease licensing agreement

Monday, September 30, 2013 02:44 PM

Gliknik, a privately-held biopharmaceutical company, has entered into an exclusive worldwide licensing agreement with Pfizer for GL-2045, Gliknik's recombinant stradomer, a drug candidate that is designed to replace and improve on pooled human intravenous immunoglobulin (IVIG). GL-2045 has shown promising results in preclinical tests and is being developed as a potential treatment for a wide variety of autoimmune diseases, including those in which IVIG is clinically used.

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Parexel launches China Trials Solution

Monday, September 30, 2013 02:40 PM

Global CRO Parexel International has launched Parexel Dĭng Huī, China Trials Solution. The offering combines advanced technology and international SOPs (Standard Operating Procedures) with local experience and resources to deliver cost-effective services that meet global quality standards. Parexel Dĭng Huī will support clients through locally delivered, streamlined services that support single-country registration trials and are tailored to meet Chinese NDA submission requirements.

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H. D. Smith acquisition Triplefin

Monday, September 30, 2013 02:37 PM

H. D. Smith, a pharmaceutical wholesaler and services provider based in Springfield, Ill., has acquired Triplefin, a reimbursement, patient assistance and pharmaceutical brand-support services company headquartered in Cincinnati, Ohio. H. D. Smith secured majority representation on Triplefin's board of directors in January and majority stock ownership interest in May. H.D. Smith has now acquired the remaining 49% of Triplefin shares, giving the company full ownership.

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Transcept, SNBL partner for acute migraine treatment

Monday, September 30, 2013 02:35 PM

Transcept Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of proprietary products to address therapeutic needs in neuroscience, and Shin Nippon Biomedical Laboratories (SNBL) have entered into an exclusive worldwide licensing agreement for a novel, rapidly absorbed treatment for acute migraine incorporating dihydroergotamine (DHE) as the active drug. 

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JSS Medical Research completes acquisition of LatAm Clinical Trials

Friday, September 27, 2013 01:23 PM

CRO JSS Medical Research has acquired LatAm Clinical Trials, a multinational CRO in South and Central America.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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The CenterWatch Monthly

September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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