Clinical trials

Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream at the Revolutionizing Atopic Dermatitis Virtual Symposium

Sunday, April 5, 2020 - 1:00pm

Incyte (Nasdaq: INCY) today announced the first presentation of Phase 3 data for ruxolitinib cream in atopic dermatitis at the Revolutionizing Atopic Dermatitis Virtual Symposium.

Key Points: 
  • Incyte (Nasdaq: INCY) today announced the first presentation of Phase 3 data for ruxolitinib cream in atopic dermatitis at the Revolutionizing Atopic Dermatitis Virtual Symposium.
  • Data that will be presented today during the Revolutionizing Atopic Dermatitis Virtual Symposium show that ruxolitinib cream significantly reduced both the skin inflammation and itch associated with atopic dermatitis.
  • The overall safety profile of ruxolitinib cream in atopic dermatitis was consistent with previous study data, with no new safety signals observed.
  • The potential of ruxolitinib cream to become an important treatment option for patients living with atopic dermatitis is exciting.

Jichi Medical University and CureApp, Inc.: The First Phase 3 Clinical Trials of "Digital Therapeutics" for Hypertension Begin in Japan

Saturday, April 4, 2020 - 3:07am

*2 Ambulatory blood pressure monitoring: Continuous measurement of blood pressure at certain intervals for 24 hours under normal lifestyle conditions.

Key Points: 
  • *2 Ambulatory blood pressure monitoring: Continuous measurement of blood pressure at certain intervals for 24 hours under normal lifestyle conditions.
  • stroke, heart disease), and the annual death toll in Japan from these diseases attributed to hypertension is estimated to reach 100,000.
  • Hypertension Digital Therapeutics: Joint development with Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine.
  • "Digital Therapeutics" is the registered trademark of CureApp, Inc.
    Head Office Location: Kodenma-Cho YS Building 4th floor, 12-5, Nihonbashi Kodenma-Cho, Chuo-ku, Tokyo, Japan

U.S. Food and Drug Administration (FDA) Approves Reblozyl® (luspatercept-aamt), the First and Only Erythroid Maturation Agent, to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)

Friday, April 3, 2020 - 10:08pm

Todays approval of Reblozyl is an important milestone for a majority of patients with myelodysplastic syndromes who have limited treatment options to address anemia associated with their disease.

Key Points: 
  • Todays approval of Reblozyl is an important milestone for a majority of patients with myelodysplastic syndromes who have limited treatment options to address anemia associated with their disease.
  • Grade 3 or 4 treatment-emergent adverse events were reported in 42.5% of patients who received Reblozyl and 44.7% of patients who received placebo.
  • In adult patients with beta thalassemia, thromboembolic events (TEE) were reported in 8/223 (3.6%) REBLOZYL-treated patients.
  • When a drug is present in animal milk, it is likely that the drug will be present in human milk.

Medpace Holdings, Inc. to Report First Quarter 2020 Financial Results on April 28, 2020

Friday, April 3, 2020 - 9:05pm

Medpace Holdings, Inc. (Nasdaq:MEDP) (Medpace) today announced that it will report its first quarter 2020 financial results after the market close on Tuesday, April 28, 2020.

Key Points: 
  • Medpace Holdings, Inc. (Nasdaq:MEDP) (Medpace) today announced that it will report its first quarter 2020 financial results after the market close on Tuesday, April 28, 2020.
  • The Company will host a conference call the following morning, Wednesday, April 29, 2020, at 9:00 a.m.
  • To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 5203559.
  • To access the conference call via webcast, visit the Investors section of Medpaces website at investor.medpace.com .

2020 Cirrhosis Clinical Trials Overview by Trial Status & Phase, Sponsor Type, End Point Status, Region and Country - ResearchAndMarkets.com

Friday, April 3, 2020 - 6:02pm

The "Cirrhosis Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Cirrhosis Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This clinical trial report, Cirrhosis Global Clinical Trials Review H1, 2020 provides an overview of Cirrhosis Clinical trials scenario.
  • The report provides top line data relating to the clinical trials on Cirrhosis.
  • The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.

Chemotherapy Induced Nausea & Vomiting: Global Clinical Trials Review H1, 2020 - ResearchAndMarkets.com

Friday, April 3, 2020 - 5:07pm

The "Chemotherapy Induced Nausea and Vomiting Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Chemotherapy Induced Nausea and Vomiting Global Clinical Trials Review, H1, 2020" clinical trials has been added to ResearchAndMarkets.com's offering.
  • This clinical trial report provides an overview of Chemotherapy Induced Nausea and Vomiting Clinical trials scenario.
  • The report provides top line data relating to the clinical trials on Chemotherapy Induced Nausea and Vomiting.
  • The report offers coverage of disease clinical trials by region, country (G7 & E7), phase, trial status, end points status and sponsor type.

FHI Clinical Providing Full-Service CRO Capabilities for Coronavirus (COVID-19) Clinical Trial

Friday, April 3, 2020 - 2:00pm

FHI Clinical Inc. announces today it has partnered with Infectious Disease Research Institute (IDRI) , a Seattle-based not-for-profit organization, to provide full-service contract research organization (CRO) capabilities for an immunotherapy clinical trial to combat moderate to severe cases of COVID-19.

Key Points: 
  • FHI Clinical Inc. announces today it has partnered with Infectious Disease Research Institute (IDRI) , a Seattle-based not-for-profit organization, to provide full-service contract research organization (CRO) capabilities for an immunotherapy clinical trial to combat moderate to severe cases of COVID-19.
  • Casper is hopeful this immunotherapy can be introduced to the market within a year, pending clinical trial success.
  • When an outbreak like coronavirus occurs, new therapies and vaccines are vital and require rapid start-up of clinical trials, commented Ted FitzGerald, FHI Clinical president and CEO.
  • FHI Clinical is a full-service contract research organization (CRO) with the global expertise, responsive approaches and proven solutions to manage complex clinical research in resource-limited settings around the world.

Insight Helps Vivli Launch COVID-19 Portal

Friday, April 3, 2020 - 1:30pm

Vivli , a global independent, nonprofit data-sharing and analytics platform for clinical trial research, with the help of Insight Enterprises (NASDAQ:NSIT), the global integrator of Insight Intelligent Technology Solutions for organizations of all sizes, has rapidly developed the COVID-19 data sharing portal.

Key Points: 
  • Vivli , a global independent, nonprofit data-sharing and analytics platform for clinical trial research, with the help of Insight Enterprises (NASDAQ:NSIT), the global integrator of Insight Intelligent Technology Solutions for organizations of all sizes, has rapidly developed the COVID-19 data sharing portal.
  • As results from those studies become available and researchers agree to share their results, Vivli will be updating the portal and listing those trials.
  • Its exciting to be able to lend support to Vivli in their efforts to launch the COVID-19 portal, said Stan Lequin, vice president, Digital Innovation at Insight.
  • Insight has been the nonprofits long-standing technical development and maintenance partner, helping Vivli launch its global clinical trial research platform in 2018.

UroGen Announces Positive Interim Data from Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

Friday, April 3, 2020 - 1:00pm

UroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC).
  • The Phase 2b OPTIMA II trial demonstrated a complete response (CR) rate at three months following onset of treatment of 65% (41/63 patients).
  • In this subset of patients, 31/32 patients (97%) and 17/20 patients (85%) remained free of disease at six and nine months follow-up, respectively.
  • UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade non-muscle invasive bladder cancer (LG NMIBC).

Novocure Provides Business Update Related to COVID-19

Friday, April 3, 2020 - 12:30pm

Novocure has cancelled patient ambassador travel and is using virtual means to ensure patients can benefit from patient ambassador support.

Key Points: 
  • Novocure has cancelled patient ambassador travel and is using virtual means to ensure patients can benefit from patient ambassador support.
  • Novocure is actively monitoring the various components of its global supply chain to ensure it maintains adequate inventories of all key products.
  • Novocure plans to provide a detailed update on its clinical development programs during its first quarter 2020 conference call.
  • Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law.