DIA Biosimilars 2013

Astellas

Astellas appoints senior vp of global oncology development

Tuesday, August 6, 2013 11:30 AM

Tokyo-based Astellas Pharma Global Development has appointed Claire Thom senior vice president of global oncology development.

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Cenduit: Now with Patient Reminders

AstraZeneca, FibroGen collaborate to develop and commercialize FG-4592

Wednesday, July 31, 2013 11:51 AM

AstraZeneca and biotechnology company FibroGen have entered into a collaboration to develop and commercialize FG-4592, a first-in-class oral compound in late stage development for the treatment of anemia associated with chronic kidney disease (CKD) and end-stage renal disease (ESRD), which also may be extended to other anemia indications.

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CRF Health – eCOA Forum

Verified Clinical Trials partners with SAFE-BioPharma

Friday, July 26, 2013 09:00 AM

Verified Clinical Trials, whose technology helps eliminate multiple enrollments by clinical trial volunteers and provides Medicare Secondary Payer Law compliance strategies, will offer its services with SAFE-BioPharma, a global digital identity management and signature standard used by many of the world’s largest biopharmaceutical companies. The company also has joined the SAFE-BioPharma Vendor Partner program, providing it with direct access to decision-makers in SAFE-BioPharma’s member companies.

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Astellas receives FDA approval of ASTAGRAF XL

Wednesday, July 24, 2013 10:15 AM

Astellas Pharmasaid the FDA has approved ASTAGRAF XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil (MMF) and corticosteroids, with or without basiliximab induction.

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Acorda Therapeutics acquires neuropathic pain assets

Thursday, July 11, 2013 12:30 PM

Acorda Therapeutics, a biotechnology company focused on developing therapies that restore function and improve the lives of people with MS, spinal cord injury and other neurological conditions, has acquired two neuropathic pain management assets from NeurogesX. Qutenza is approved by the FDA for the management of neuropathic pain associated with postherpetic neuralgia. The company also acquired NP-1998 (previously NGX-1998), a phase III ready, prescription strength capsaicin topical solution.

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Seattle Genetics, Agensys to co-develop ADC

Wednesday, July 3, 2013 09:30 AM

Seattle Genetics has exercised an option to co-develop an additional antibody-drug conjugate (ADC) under an existing ADC collaboration agreement with Agensys, an affiliate of Tokyo-based Astellas Pharma. The ADC, called ASG-15ME, targets the tumor antigen SLITRK6, which is expressed on bladder and lung cancer.

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InnovoCommerce, SAFE-BioPharma collaborate

Friday, June 28, 2013 02:02 PM

The global SAFE-BioPharma digital identity and signature standard is being incorporated into the InnovoCommerce eClinical product suite used by pharmaceutical companies for their enterprise and investigator portal initiatives. InnovoCommerce is a source of eClinical collaboration products and solutions. It also has joined SAFE-BioPharma Association’s Vendor Partner program.

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Cytokinetics, Astellas collaborate on skeletal muscle activation

Thursday, June 27, 2013 03:15 PM

Biopharmaceuticals Cytokinetics and Astellas Pharma are collaborating on the research, development and commercialization of skeletal muscle activators. The primary objective of the collaboration is to advance novel therapies for diseases and medical conditions associated with muscle weakness. The companies will jointly conduct research in the area of skeletal muscle activation.

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Astellas Pharma joins SAFE-BioPharma

Friday, June 21, 2013 01:21 PM

Astellas Pharma has joined the SAFE-BioPharma Association, a nonprofit industry coalition responsible for the ongoing development and implementation of the global SAFE-BioPharma digital identity and signature standard. As a member, Astellas is able to utilize the SAFE-BioPharma standard. It is the first Japanese pharmaceutical company to become a member.

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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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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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