DIA Biosimilars 2013

Eisai

Eisai, Clinigen partner on patient access program in Germany

Monday, September 9, 2013 11:56 AM

Eisai EMEA, an R&D based pharmaceutical company, has established a named patient access program to ensure patients continue to receive an uninterrupted supply of the anti-epilepsy drug Fycompa (perampanel), following the temporary suspension of commercial distribution in Germany. The access program will be managed by Clinigen Global Access Programs (GAP), a U.K.-headquartered specialty global pharmaceutical company.

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Cenduit: Now with Patient Reminders

Morphotek announces initiation of phase I study for MORAb-066

Wednesday, July 3, 2013 02:16 PM

Biopharmaceutical Morphotek, a subsidiary of Eisai, has announced that the Sarah Cannon Research Institute in Nashville, Tenn., has opened enrollment in a phase I clinical study with MORAb-066 in patients with advanced or metastatic breast, pancreatic, colorectal or non-small cell lung cancer (adenocarcinoma) malignancies. The open-label, phase I study will assess the safety, tolerability and pharmacokinetics of MORAb-066 administered with weekly intravenous infusions.

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CRF Health – eCOA Forum

Japan screening massive drug compound libraries for new treatments

Wednesday, June 5, 2013 01:32 PM

The Global Health Innovative Technology Fund (GHIT Fund), a public-private partnership focused on Japanese R&D related to infectious disease, will make a series of agreements to screen compound libraries at Japanese pharmaceutical companies and research institutes for new treatments for malaria, tuberculosis and other afflictions.

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Eisai to establish new parenteral facility in China

Friday, April 26, 2013 12:28 PM

Eisai, a Japanese pharmaceutical company, has decided to establish a new parenteral facility on a lot retained by Eisai's Chinese subsidiary, Eisai China, at the Suzhou Industrial Park in Suzhou, China. 

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Lynn Kramer appointed chief clinical officer of Eisai Product Creation Systems

Friday, April 12, 2013 02:13 PM

Eisai has appointed Lynn Kramer, MD, to the newly created position of chief clinical officer of Eisai Product Creation Systems.

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Japan establishes global fund for R&D of new medicines, vaccines, diagnostics

Wednesday, April 10, 2013 10:15 AM

Japan’s first public-private partnership to advance the development of new health technologies for the developing world The Global Health Innovative Technology Fund (GHIT Fund) has officially launched. The GHIT Fund has been established to advance the R&D of new medicines, vaccines and diagnostics to fight infectious diseases in the developing world.

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Eisai, UCL form drug discovery alliance for neurological diseases

Friday, December 14, 2012 10:43 AM

Eisai, a pharmaceutical company based in Toyko, and University College London (UCL) have entered into a new agreement to establish a major drug discovery and development collaboration investigating new ways of treating neurological diseases such as Alzheimer’s disease, Parkinson’s disease and other related disorders.

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Epizyme earns $4M in milestones from GSK for novel HMT therapeutics

Thursday, October 4, 2012 11:52 AM

Epizyme, a pharmaceutical company focused personalized therapeutics for cancer, received a $4 million milestone payments from collaborator GlaxoSmithKline based on the achievement of pre-clinical milestones.

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Eisai partners with PharmaSwiss on chemo agent distribution

Monday, April 9, 2012 02:19 PM

Eisai Europe, the Tokyo-based subsidiary of Eisai, has entered into an agreement with PharmaSwiss, the Switzerland-based division of Valeant Pharmaceuticals International, to promote and distribute the Eisai's novel anticancer agent Halaven (eribulin mesylate) in a number of Central and Eastern European (CEE) countries.

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Eisai resubmits Perampanel NDA to FDA

Tuesday, December 27, 2011 01:28 PM

Eisai has resubmitted the New Drug Application (NDA) for the investigational AMPA-type glutamate receptor antagonist perampanel for partial-onset seizures associated with epilepsy to the FDA. This resubmission comes after the FDA issued a Refusal to File letter in July 2011 in which FDA requested reformatting and reanalyses of some datasets in the dossier. The application was originally submitted in May 2011.

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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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