Trial results released for voxelotor as sickle cell therapy | EU grants full approval to Amgen's Blincyto | Quizartinib extends survival in rare form of leukemia
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June 21, 2018
DIA Global SmartBrief
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Trial results released for voxelotor as sickle cell therapy
Global Blood Therapeutics reported on data from a Phase IIa study of drug candidate voxelotor in 22 adolescents with sickle cell disease. Durable and sustained improvements were seen in hemoglobin levels, and clinical measures of hemolysis decreased, according to a presentation at the European Hematology Association's annual meeting.
Seeking Alpha (6/15) 
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Experience in Bringing Clinical Trials to Life
From oncology and neuro degenerative, to pediatrics, rare/orphan, and more, Synteract is an innovative, full service CRO with 30+ years of experience and 240+ product approvals to our name. See us at booth 1104, DIA 2018. Discover how you can benefit from our therapeutic & operational expertise.
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Europe
EU grants full approval to Amgen's Blincyto
Amgen received full approval from the European Commission for its Blincyto, or blinatumomab, to be used as a treatment for adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The decision was based on overall survival data from the late-stage TOWER study, in which patients who received Blincyto experienced a median OS of 7.7 months compared with four months for standard of care chemotherapy.
PharmaTimes online (UK) (6/20) 
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Quizartinib extends survival in rare form of leukemia
The investigational drug quizartinib was found to extend survival in adults with relapsed acute myeloid leukemia and FLT3 internal tandem duplication compared with salvage chemotherapy in 367 patients, based on data from a Phase III study presented at the European Hematology Association's annual meeting. Median overall survival of those treated with quizartinib was 6.2 months versus 4.7 months for patients treated with standard salvage chemotherapy.
Specialty Pharmacy Times (6/19),  MedPage Today (free registration) (6/19) 
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What does 2018 have in store for pharma?
Take an in-depth look at trends in the industry that are anticipated to make a significant impact on the sector in 2018. Discover how the 21st Century Cares Act will change the business, why Artificial Intelligence can revolutionize drug discovery, and why the issue of Compounding Drugs and interstate commerce is a hot-button topic. Read more.
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Asia Pacific
Medical device to cultivate stem cells could reduce carcinogenesis risk
Researchers at Hong Kong Baptist University have developed a device that could lower the chances of carcinogenesis when neural stem cells are being cultivated to treat diseases such as Alzheimer's and Parkinson's. The device has a nanotechnology layer that differentiates neural stem cells without the use of growth factor.
Xinhua News Agency (China) (6/19) 
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USFDA: Taiwan Biotech violated good manufacturing practices
Taiwan Biotech received a warning letter from the USFDA for "significant violations" of good manufacturing practices after an inspection in September found that the company failed to keep accurate records and had not enacted sound lab practices for testing its drugs. The warning letter asked the company to begin measures this month to fix the problems.
BioSpectrum Asia (6/19) 
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Accelerate Clinical Trial Recruitment
InterSystems Healthshare can help accelerate trial recruitment through real-time dynamic cohort management and engaging physicians for trial recruitment within their clinical workflow at the point of care. Visit booth # 1454 at DIA or click here to learn more.
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North America
Bendamustine raises risk for common infections in lymphoma patients
A study in the journal Clinical Infectious Diseases found that patients with indolent non-Hodgkin lymphoma face a higher risk of acquiring common and opportunistic infections when treated with bendamustine than with other chemotherapy regimens. The analysis of data from 9,395 iNHL patients who underwent chemotherapy between 2006 and 2013 found that 47.6% of patients treated with bendamustine experienced more advanced clinical disease at baseline, compared with 39.8% of patients receiving other treatments, and patients treated with bendamustine also required more chemotherapy sessions and had higher neutropenia rates.
Healio (free registration)/Infectious Disease News (6/18) 
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GSK's Benlysta for SLE found safe over time
Results from a study sponsored by GlaxoSmithKline looking at Benlysta, or belimumab, for the treatment of systemic lupus erythematosus, show that the safety profile has remained stable over time. Patients treated with belimumab for up to nine years experience few if any adverse events in the later years of treatment.
MedPage Today (free registration) (6/18) 
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Small-cell lung cancer patients benefit from PARP inhibitor
Recent study data shows that adding the poly ADP-ribose polymerase (PARP) inhibitor veliparib to standard chemotherapy improved overall response rate for patients with small-cell lung cancer. The Phase II study at the University of Texas MD Anderson Cancer Center also led to the discovery of a biomarker that may indicate which patients will derive the most benefit from the treatment protocol.
Specialty Pharmacy Times (6/18) 
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Global
Study: Recommended malaria treatments inadequate for pregnant women, children
Recommended treatment regimens for uncomplicated Plasmodium falciparum malaria were insufficient for children and women in the second and third trimesters of pregnancy, according to an analysis based on data for 4,546 patients in PLOS Medicine. "From a pharmacological perspective, a dose extension -- twice-daily dosing at the current dosage for 5 days -- for children 25 kg or less and pregnant women during the second and third trimester probably has the greatest advantages for therapeutic efficacy," researchers wrote.
Healio (free registration)/Infectious Diseases in Children (6/18) 
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Trial results for liver cancer drug namodenoson delayed
The results for the Phase II trial of Can-Fite BioPharma's liver cancer candidate CF102, or namodenoson, will be delayed until later this year, according to the Israeli biotech firm. Company officials said they were encouraged by the survival rates of some trial participants, who have advanced hepatocellular carcinoma that progressed during treatment with sorafenib.
Pharmaceutical Business Review Online (6/20) 
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DIA News
DIA 2018 Global Annual Meeting
Hurry and save your seat for DIA's most-anticipated event of the year, the DIA 2018 Global Annual Meeting, taking place June 24-28 in Boston. With over 250 sessions across 12 learning tracks, this is your chance to engage with your industry, government and academic peers from around the world. A few popular sessions include:
  • All Hands on Deck: Using Science to Help Solve the Opioid Crisis
  • Analyzing Innovations Progress in the Gottlieb Era
  • International Regulatory Convergence
  • Payers, Industry, and Academia Collaborating on Post-Marketing Surveillance
  • On the Soap Box: Right to Try
For all event details, download the final program and be sure to register today!
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