Clinical Intelligence

Wave Life Sciences initiates Duchenne muscular dystrophy clinical trial

Monday, November 6, 2017

Wave Life Sciences, a biotechnology company focused on delivering transformational therapies for patients with serious, genetically-defined diseases, announced the initiation of a global phase I clinical trial for WVE-210201 in Duchenne muscular dystrophy (DMD) patients amenable to exon 51 skipping. This clinical trial marks the next stage in the company’s ongoing commitment to address the significant unmet needs of patients diagnosed with this devastating disease and it is the company’s third clinical trial initiated in 2017.

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Insys Therapeutics founder arrested on charges of racketeering

Monday, November 6, 2017

On the very same day President Donald Trump declared the opioid crisis to be a nationwide public health emergency, Insys Therapeutics founder and majority owner John Kapoor was arrested. He was charged with leading a nationwide conspiracy to profit by using bribes and fraud to cause the illegal distribution of his company’s Fentanyl spray, Subsys, intended for cancer patients experiencing breakthrough pain. 

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Jazz Pharma submits Vyxeos MAA to EMA for high-risk AML

Friday, November 3, 2017

Jazz Pharmaceuticals announced the submission of a Marketing Authorization Application (MAA) to the EMA‘s Committee for Medicinal Products for Human Use (CHMP) for Vyxeos (daunorubicin and cytarabine) powder for concentrate for infusion to treat adults with high-risk acute myeloid leukemia (AML) defined as therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

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Rethinking the Investigator’s brochure

Wednesday, November 1, 2017

The investigator’s brochure (IB) has long functioned as the main reference document for clinical trials, providing investigators with information needed to understand possible risks or adverse events (AEs) related to the investigational product and keep sites up-to-date on the study. Yet IBs are invariably lengthy, complex documents that are seldom read cover-to-cover or consulted when questions arise. While new technology has impacted many clinical research domains to improve the usability and efficiency of documents or processes, IBs remain a relic of another era.

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CureVac initiates phase I trial of RNAdjuvant for solid tumors

Tuesday, October 31, 2017

CureVac, a fully-integrated biotechnology company pioneering mRNA-based drugs, has initiated a phase I study assessing the intratumoral application of its novel RNAdjuvant technology in patients with superficial solid tumors that are easily accessible for repeated intratumoral injections. RNAdjuvant is designed to amplify the scope and quality of an immune response when used alone or in combination with other immune therapies.

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Clinical research in the cloud, with help from Microsoft

Monday, October 30, 2017

Clinical research technology is expanding, and there is now infrastructure to back it. Last week, Parexel, a global clinical research organization, announced a new partnership with Microsoft to develop innovative cloud-based services for their clients. The collaboration will bring Parexel’s current tech offerings to the Microsoft Azure cloud platform and catalyze new developments aimed at enhancing participant engagement in clinical trials, and streamlining drug development.

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FDA approves Bydureon BCise for type 2 diabetes

Thursday, October 26, 2017

AstraZeneca announced that the FDA has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon (exenatide extended-release) injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycemic control.

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Shire’s SHP654 receives Orphan Designation for hemophilia A

Thursday, October 26, 2017

Shire, a global biotechnology leader in rare diseases, announced the FDA awarded Orphan Drug Designation to Shire’s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.

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