Oramed Initiates Food Effect Study for Its Oral Insulin Capsule ORMD-0801

Oramed Initiates Food Effect Study for Its Oral Insulin Capsule ORMD-0801

The food effect study is a single blind, five period, randomized, placebo-controlled crossover study to evaluate the pharmacokinetics and pharmacodynamics of ORMD-0801 taken at different times in relation to meals in healthy volunteers and subjects with type 1 diabetes. Up to 48 subjects will be enrolled including 24 healthy volunteers and 24 subjects with type […]

HTX-011 for Postoperative Pain Management Receives Breakthrough Therapy Designation from FDA

HTX-011 for Postoperative Pain Management Receives Breakthrough Therapy Designation from FDA

SAN DIEGO–(BUSINESS WIRE)–Jun 21, 2018–Heron Therapeutics, Inc. (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that HTX-011 for postoperative pain management has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA). […]

Incyte Announces REACH1 Pivotal Trial Meets Primary Endpoint of Overall Response Rate for Ruxolitinib (Jakafi

Incyte Announces REACH1 Pivotal Trial Meets Primary Endpoint of Overall Response Rate for Ruxolitinib (Jakafi

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced positive topline results from its ongoing pivotal Phase 2 REACH1 trial evaluating ruxolitinib (Jakafi®) in combination with corticosteroids for the treatment of patients with steroid-refractory acute graft-versus-host disease (GVHD). The study met its primary endpoint, demonstrating an overall response rate (ORR) of 55 percent (n=39/71) at Day 28. […]

“Right To Try” and Ortho

Source: Freedom’s Phoenix “Right To Try” and Ortho Walter Eisner • Wed, June 20th, 2018 Print this article The new “Right To Try” legislation signed into law by the President on May 30, 2018, will impact orthopedic providers if they have patients who have been diagnosed with a life-threatening disease or condition, have exhausted all […]

Paratek Announces FDA Advisory Committee Date for Omadacycline

Paratek Announces FDA Advisory Committee Date for Omadacycline

BOSTON, June 20, 2018 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, today announced that a meeting of the Antimicrobial Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has been scheduled for August 8, 2018 to review the Company’s New […]

3D printed biomaterial promotes tissue regeneration

3D printed biomaterial promotes tissue regeneration

3D printed biomaterial promotes tissue regeneration – Physics World View our other sites MENU MENU Discover more from Physics World Related journal articles from IOPscience Related products and services Copyright © 2018 by IOP Publishing Ltd and individual contributors bright-rec iop pub iop-science physcis connect Source link

Dr. Davids Discusses Duvelisib in Relapsed/Refractory CLL

Dr. Davids Discusses Duvelisib in Relapsed/Refractory CLL

Matthew S. Davids, MD, MMSc, associate director, Center for Chronic Lymphocytic Leukemia, Dana-Farber Cancer Institute, discusses duvelisib in relapsed/refractory chronic lymphocytic leukemia (CLL). In April 2018, the FDA granted a priority review to a new drug application (NDA) for duvelisib for patients with relapsed/refractory CLL and small lymphocytic lymphoma. The NDA was based on data […]

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