DIA Biosimilars 2013

Aeterna Zentaris

Aeterna Zentaris announces first patient dosed in phase III endometrial cancer trial

Friday, August 9, 2013 02:05 PM

Aeterna Zentaris has announced the first patient has been recruited and dosed for the phase III ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with endometrial cancer resistant to platinum/taxane-based chemotherapy.

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Cenduit: Now with Patient Reminders

David A. Dodd appointed president and CEO of Aeterna Zentaris

Friday, April 26, 2013 03:05 PM

Aeterna Zentaris, an oncology and endocrinology drug development company, has appointed David A. Dodd as president and CEO, succeeding Juergen Engel, PhD. Dodd has also been appointed director on the company's board of directors.

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CRF Health – eCOA Forum

Aeterna Zentaris granted SPA for phase III endometrial cancer trial

Friday, January 4, 2013 02:24 PM

The FDA has granted Aeterna Zentaris Special Protocol Assessment (SPA) for an upcoming phase III registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108.

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Yakult initiates phase I trial in multiple myeloma with perifosine in Japan

Friday, June 29, 2012 12:12 PM

Aeterna Zentaris’ Japanese partner Yakult Honsha has initiated a phase I trial in multiple myeloma with perifosine, the company's oral Akt/PI3K inhibitor drug.

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Aeterna Zentaris, Hikma partner in commericalization of Perifosine

Wednesday, November 23, 2011 10:03 AM

Aeterna Zentaris and Hikma Pharmaceuticals have signed an exclusive commercialization and licensing agreement for the registration and marketing of perifosine, Aeterna Zentaris' lead anti-cancer compound, for the MENA (Middle East and North Africa) region. Perifosine, a novel oral Akt inhibitor, is currently in two phase III programs for the treatment of colorectal cancer and multiple myeloma in the United States and Europe.

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Aterena Zentaris’ AGHD study shows favorable results

Tuesday, August 30, 2011 12:03 PM

Aeterna Zentaris has reported favorable top-line results of its completed phase III study with AEZS-130 as the first oral diagnostic test for Adult Growth Hormone Deficiency (AGHD). The results show that AEZS-130 reached its primary endpoint demonstrating >90% area-under-the-curve (AUC) of the Receiver Operating Characteristic curve, which determines the level of specificity and sensitivity of the product. The company is currently proceeding with further detailed analyses of the data and preparing for a pre-New Drug Application (NDA) meeting with the FDA in the upcoming months, which would be followed by the filing of a NDA for the registration of AEZS-130 in the United States.

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Aeterna Zentaris to present phase II AEZS-108 results

Wednesday, July 20, 2011 11:25 AM

Aeterna Zentaris will present the final phase II  results in endometrial cancer on its anticancer compound, AEZS-108, during a poster session at the upcoming 17th International Meeting of the European Society of Gynaecological  Oncology ("ESGO"), Sept. 11-14 in Milan, Italy.

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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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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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