DIA Biosimilars 2013

Articles Published in 2012

Allegro Diagnostics reveals positive results of BronchoGen genomic test for lung cancer

Wednesday, October 24, 2012 11:43 AM

Allegro Diagnostics, a molecular diagnostics company based in Maynard, Mass., released positive results from the AEGIS I (Airway Epithelium Gene Expression In the Diagnosis of Lung Cancer) clinical trial, which demonstrate the diagnostic accuracy of the BronchoGe genomic test in combination with bronchoscopy.

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Cenduit: Now with Patient Reminders

Seattle Genetics, Abbott expand antibody-drug conjugate collaboration

Wednesday, October 24, 2012 11:02 AM

Seattle Genetics, a Bothell, Wash.-based biotech focused on monoclonal antibody-based therapies for the treatment of cancer, has expanded its antibody-drug conjugate (ADC) collaboration with Abbott Laboratories, a global healthcare company.

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CRF Health – eCOA Forum

Forest Laboratories, moksha8 form strategic alliance for Latin America

Wednesday, October 24, 2012 10:33 AM

Forest Laboratories, an international pharmaceutical company, and moksha8, a pharmaceutical company that commercializes CNS medicines in Latin America, have entered into a broad strategic alliance that will provide Forest with a commercial footprint in Latin America and give moksha8 access to Viibryd and potentially other Forest products for the Latin American market.

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PFF calls for letters of intent for 2013 Young Investigator and Established Investigator awards

Wednesday, October 24, 2012 10:11 AM

The Pulmonary Fibrosis Foundation (PFF) is accepting letters of intent for its 2013 PFF Research Fund grants.  Letters of intent will be accepted until Monday, November 26.  

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EMA investigates Roche's alleged non-compliance with pharmacovigilance obligations

Wednesday, October 24, 2012 09:46 AM

The European Medicines Agency (EMA) has initiated an infringement procedure against Roche Registration, following a request of the European Commission, to investigate allegations that the company has failed to comply with pharmacovigilance obligations in relation to its 19 centrally authorized medicines.

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Cortex unveils growth plans, 1,400 new jobs

Wednesday, October 24, 2012 09:24 AM

Cortex, a St. Louis-based hub of bioscience and technology R&D and commercialization, has unveiled phase two of its 25-year master plan, which will bring 1,400 new jobs and 384,000 square feet of additional lab and office space to the district.

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Bayer’s riociguat meets primary endpoint in phase III study in PAH

Tuesday, October 23, 2012 07:15 AM

Bayer HealthCare Pharmaceuticals, the U.S.-based pharmaceuticals business of Bayer HealthCare, issued data from the phase III PATENT-1 pulmonary arterial hypertension (PAH) trial evaluating its investigational drug riociguat in both treatment-naive patients and those pre-treated with an endothelin receptor antagonist or an oral, inhaled or subcutaneous prostanoid.

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Lilly touts positive results from phase III trials of dulaglutide in T2D

Monday, October 22, 2012 01:24 PM

Global pharmaceutical company Eli Lilly released positive top-line results of three completed phase III AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 (GLP-1) analog being studied as a once-weekly treatment for type 2 diabetes.

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Pfizer to acquire NextWave Pharmaceuticals

Monday, October 22, 2012 12:56 PM

Pfizer, a global research-based pharmaceutical company, has agreed to acquire NextWave Pharmaceuticals, a privately-held, specialty pharmaceutical company focused on attention deficit/hyperactivity disorder (ADHD) and related central nervous system (CNS) disorders.

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AMRI, Shire ink 5-year extension of API supply agreement

Monday, October 22, 2012 12:22 PM

AMRI, a global contract research and manufacturing organization, has entered into a multi-year supply agreement for an undisclosed product with Shire U.S. Manufacturing, a subsidiary of specialty biopharmaceutical company Shire.

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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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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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