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Articles Published in 2011

Bionovo enrolls first patient in phase III Menerba trial

Tuesday, November 22, 2011 02:36 PM

Bionovo has reported that the first patient has now been randomized and will begin dosing in the phase III pivotal clinical trial evaluating the safety and efficacy of two doses of Menerba (MF101) among a cohort of postmenopausal women for the treatment of menopausal hot flashes.

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Cenduit: Now with Patient Reminders

Ferring Pharmaceuticals to open operations center in New Jersey

Tuesday, November 22, 2011 02:07 PM

Switzerland-based Ferring Pharmaceuticals has purchased a 25-acre site in Parsippany, N.J.  The new facility will house a state-of-the art, expanded U.S. Operations Center. The expansion is expected to generate jobs in the New Jersey area.

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CRF Health – eCOA Forum

Coldstream Laboratories names VP of manufacturing

Tuesday, November 22, 2011 01:37 PM

Coldstream Laboratories, a provider of drug product research and manufacturing services, has named Dr. Vickie Hall vice president of manufacturing. Hall will assume responsibility of Coldstream's manufacturing, facilities, and warehouse operations.

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Researchers discover new drug combo targeting multiple cancers

Tuesday, November 22, 2011 12:11 PM

Researchers at the University of California, San Diego School of Medicine and Kyushu University Medical School say a novel combination of a specific sugar molecule with a pair of cell-killing drugs prompts a wide variety of cancer cell types to kill themselves, a process called apoptosis or programmed cell death. The findings are reported online in the journal Cancer Research.

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PAREXEL advances early phase research technology

Tuesday, November 22, 2011 11:55 AM
PAREXEL International has enhanced its central nervous system (CNS)
capabilities for clinical development through the implementation of
functional magnetic resonance imaging (fMRI) technology in its Early Phase
units. This advanced imaging scanning measures hemodynamic response, or
change in blood flow, related to neural activity in the brain or spinal
cord. Through this approach, PAREXEL is able to provide sponsors with
improved testing paradigms for cognitive biomarkers and better understand
the impact of compounds earlier in disease progression.

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Savara joins SAFE-BioPharma

Tuesday, November 22, 2011 11:25 AM
Savara Pharmaceuticals, an inhalation drug development company, has joined SAFE-BioPharma Association. SAFE-BioPharma manages the SAFE-BioPharma digital identity and signature standard, used throughout the biopharmaceutical industry to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents.

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Isis to receive $14 million from Pfizer's Excaliard acquisition

Tuesday, November 22, 2011 11:12 AM
Isis Pharmaceuticals will receive up to $14 million from Pfizer for its equity ownership of Excaliard Pharmaceuticals from Pfizer's acquisition of Excaliard. Upon closing of the acquisition, Isis will receive an initial $4.4 million. Contingent payments of up to an additional $9.6 million could be paid to Isis upon achievement of various milestones associated with the clinical and commercial progress of EXC 001. Isis will continue to be eligible for milestone and royalty payments under its licensing agreement with Excaliard for EXC 001.

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Lilly awards IDRI $4 million in tuberculosis research funding

Tuesday, November 22, 2011 10:55 AM

The Infectious Disease Research Institute (IDRI) has been awarded more than $4 million in additional funding over the next four and a half years by Eli Lilly. The funding will support IDRI’s continued early phase drug discovery research, which focuses on the identification of effective new therapies in the fight against tuberculosis (TB), including multidrug-resistant TB (MDR-TB).

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Tasly Pharmaceuticals selects ICON for phase III T89 trial

Monday, November 21, 2011 04:52 PM

ICON has been selected by Tasly Pharmaceuticals for the company’s global phase III T89 trial. T89, also known as Dantonic pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States. Dantonic pill is a botanical product for the treatment of chronic stable angina pectoris due to coronary heart disease. It is a modernized version of a traditional Chinese herbal medicine and was approved by the State Food and Drug Administration (SFDA) of China in 1993. Since then, more than 2 billion doses have been used by over 10 million patients. 

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Roche, Cedars-Sinai Medical Center enter five year alliance

Monday, November 21, 2011 04:19 PM

Roche has established a strategic alliance with Cedars-Sinai Medical Center in Los Angeles for the center to operate as a Roche Molecular Center of Excellence (MCOE) for the next five years.

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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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