FDA filing for hereditary angioedema (HAE) drug planned after phase 3 clinical trials success

Shire Plc plans to file for regulatory approval of its drug lanadelumab for the rare genetic disorder hereditary angioedema (HAE) on the back of new phase 3 data. The trials showed that the drug reduces monthly swelling attacks when taken as a preventative treatment.

HAE is a rare inherited blood disorder that can cause dangerous episodes of swelling in the face, extremities, gastrointestinal track, airway and/or genitals. The swelling is often highly painful and can be life-threatening if it obstructs the airway. HAE affects approximately 6,000 people in the United States.

Massachusetts General Hospital was one of the trial sites for the new therapy. Clinical trial investigator Aleena Banerji, MD, of Mass General said: “If approved, lanadelumab may offer patients a long-acting treatment option that significantly reduces HAE attacks when administered subcutaneously as infrequently as every four weeks.”


Massachusetts General Hospital and Brigham and Women's Hospital to collaborate with GE Healthcare on deep learning technology for medicine

Boston-based Partners HealthCare on Wednesday said it plans to integrate deep learning technology from GE Healthcare across its network.

The 10-year collaboration will involve Massachusetts General Hospital and Brigham and Women's Hospital Center for Clinical Data Science.

The initiative will feature co-located, multidisciplinary teams with broad access to data, computational infrastructure and clinical expertise. The initial focus will be on the development of applications aimed at improving clinician productivity and patient outcomes in diagnostic imaging.


Harvard-Massachusetts General Hospital Liquid Biopsy Assay Targets Early Detection of Pancreatic Cancer

A multiplexed nanoplasmonic assay designed specifically to fit into clinical workflows is taking aim at high-throughput detection of pancreatic ductal adenocarcinoma (PDAC), an aggressive and often inoperable form of pancreatic cancer. Developed by researchers at Harvard Medical School and Massachusetts General Hospital, the assay employs a liquid biopsy approach, leveraging low blood volumes and the clinical potential of exosomes — tiny vesicles shed by all kinds of cells, including tumor cells.

The researchers said that Cambridge, Massachusetts-based Exosome Diagnostics has licensed the technology and is exploring integrating the test with its own portfolio of exosome tests to explore the potential for "doing concurrent testing of exosome-based proteins and mRNA."


Mass General Researcher to Help Evaluate New Treatment for Non-Small Cell Lung Cancer

Pasi A. Jänne, MD, PhD, of the Dana-Farber/Brigham and Women's Cancer Center and the Massachusetts General Hospital Cancer Center was one of two investigators to receive funding from The National Comprehensive Cancer Network® (NCCN®) Oncology Research Program (ORP), through a collaborative scientific research relationship with AstraZeneca, to further evaluate the clinical effectiveness of osimertinib in the treatment of epidermal growth factor receptor-positive (EGFRm+) non-small cell lung cancer (NSCLC).


The most important medical entrepreneur you've never heard of

Have you ever received laser hair removal or CoolSculpting, a new treatment to combat cellulite bulges? If so, you’ve been touched by technology and research from Mass General. Meet Dr. Richard Rox Anderson, the Mass General entrepreneur-researcher behind these innovations, in this recent Boston Globe article.


Mass General collaborating with 1Drop Diagnostics to test new device for diagnosing heart conditions

Doctors at Mass General are collaborating with 1Drop Diagnostics to evaluate a point of care diagnostic device for cardiovascular diseases. The device, comprising a disposable microfluidic chip and reusable reader, could replace time-consuming and expensive lab blood tests with a simple pinprick test that is completed during a primary care visit. If successful, the diagnostic may allow clinicians to make quick decisions in an emergency while reducing costs.

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