Oxadiazoles

BriaCell Phase I/IIa Clinical Trial Combination Study in Advanced Breast Cancer Patients Open for Enrollment

Retrieved on: 
Wednesday, July 14, 2021
Cancer treatments, Clinical medicine, Chemical compounds, Epacadostat, Oxadiazoles, Incyte, Indoleamine 2,3-dioxygenase, Cancer immunotherapy, Antineoplastic drugs, Breakthrough therapy, Pembrolizumab

The Phase I/IIa combination study is designed to evaluate BriaCells lead candidate, Bria-IMT, with Incytes checkpoint inhibitor, retifanlimab, and IDO1 inhibitor, epacadostat, for the treatment of advanced breast cancer.

Key Points: 
  • The Phase I/IIa combination study is designed to evaluate BriaCells lead candidate, Bria-IMT, with Incytes checkpoint inhibitor, retifanlimab, and IDO1 inhibitor, epacadostat, for the treatment of advanced breast cancer.
  • The BriaCell and Incyte clinical program is a non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates.
  • Under the agreement, Incyte is providing compounds from its development portfolio, including retifanlimab, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with Bria-IMT, in advanced breast cancer patients.
  • BriaCell and Incyte had previously treated two patients under this Phase I/IIa combination study subsequent to the corporate collaboration commencement in April 2019 .

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis1

Retrieved on: 
Thursday, May 27, 2021
Science, Biotechnology, Research, Pharmaceutical, Managed care, Health, FDA, Clinical trials, Medical specialties, Clinical medicine, Immunology, Nitriles, Ethanolamines, Oxadiazoles, Ozanimod, Monoclonal antibodies, Immunosuppressants, Ulcerative colitis, European Medicines Agency, Ustekinumab

A Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active UC in the European Union is currently under review with the European Medicines Agency (EMA).

Key Points: 
  • A Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active UC in the European Union is currently under review with the European Medicines Agency (EMA).
  • Bristol Myers Squibb is continuing to evaluate Zeposia in an open-label extension trial, which is ongoing and designed to assess the longer-term profile of Zeposia for the treatment of moderately to severely active ulcerative colitis.
  • Zeposia was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) in March 2020.
  • The European Medicines Agency (EMA) validated Bristol Myers Squibbs Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis in December 2020.

Bristol Myers Squibb Presents New Data at Digestive Disease Week® on Zeposia (ozanimod) Highlighting Clinical Benefits and Safety Profile in Patients with Ulcerative Colitis

Retrieved on: 
Sunday, May 23, 2021
Health, Other Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Medical specialties, Clinical medicine, Medicine, Diarrhea, Ethanolamines, Nitriles, Oxadiazoles, Ozanimod, Autoimmune diseases, Ulcerative colitis, Placebo, Colitis, True North, Ulcerative Colitis, Zeposia (ozanimod), Digestive Disease Week® (DDW), Bristol Myers Squibb, TRUE NORTH, ULCERATIVE COLITIS, ZEPOSIA (OZANIMOD), DIGESTIVE DISEASE WEEK® (DDW), BRISTOL MYERS SQUIBB

Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study.

Key Points: 
  • Of these, 80% and 54.6% of patients who received Zeposia and placebo, respectively, completed the study.
  • Patients discontinuing treatment due to TEAEs included 3 patients receiving Zeposia and 6 patients receiving placebo; disease relapse (13.5% Zeposia, 33.9% placebo) was the most common reason for discontinuation.
  • Ulcerative colitis has a major impact on patients' health-related quality of life, including physical functioning, social and emotional well-being and ability to work.
  • The European Medicines Agency validated Bristol Myers Squibb\xe2\x80\x99s Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis in December 2020.

Bristol Myers Squibb's Zeposia and Biogen's Vumerity Place Competitive Pressure on Established Brands in the Multiple Sclerosis Switch Segment, According to Spherix Global Insights

Retrieved on: 
Wednesday, March 31, 2021
Chemical compounds, Chemistry, Organic compounds, Multiple sclerosis, Ethanolamines, Nitriles, Oxadiazoles, Ozanimod, Entheogens, Sphingosine-1-phosphate, Fingolimod, N,N-Dimethyltryptamine

Spherix has been tracking the switch segment of the MS market through their RealWorld Dynamix: DMT Switching in Multiple Sclerosis (US) service for the last six years.

Key Points: 
  • Spherix has been tracking the switch segment of the MS market through their RealWorld Dynamix: DMT Switching in Multiple Sclerosis (US) service for the last six years.
  • Indeed, Vumerity is the only fumarate agent that found more patients switching to the brand than away from it.
  • Recent switches to next-generation S1P receptor modulators, Novartis' Mayzent and Bristol Myers Squibb's Zeposia , now exceed the number of switches to well-established Gilenya.
  • The 2021 audit is the sixth annual edition included in the RealWorld Dynamix: DMT Switching in Multiple Sclerosis (US) service.

Bristol Myers Squibb Application for Zeposia® (ozanimod) for the Treatment of Ulcerative Colitis Accepted for Filing with Priority Review by U.S. Food and Drug Administration

Retrieved on: 
Monday, February 1, 2021
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Medical specialties, Clinical medicine, Immunology, Autoimmune diseases, Nitriles, Monoclonal antibodies, Ethanolamines, Oxadiazoles, Ozanimod, Ulcerative colitis, Bristol Myers Squibb, Celgene, True North, Ulcerative Colitis, Zeposia, Bristol Myers Squibb

Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC).

Key Points: 
  • Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC).
  • Bristol Myers Squibb thanks the patients and investigators who participated in the Zeposia Phase 3 UC True North clinical trial.
  • Cohort 2 (n=367) was an open-label arm where patients were treated once daily with Zeposia for 10 weeks.
  • The European Medicines Agency validated Bristol Myers Squibbs Marketing Authorization Application for Zeposia for the treatment of adults with moderately to severely active ulcerative colitis in December 2020.

PTC Therapeutics Reports First Quarter 2020 Financial Results and Provides a Corporate Update

Retrieved on: 
Thursday, April 30, 2020
Ataluren, Cystic fibrosis, Oxadiazoles, PTC Therapeutics, PTC, GAAP

SOUTH PLAINFIELD, N.J., April 30, 2020 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the first quarter ending March 31, 2020.

Key Points: 
  • SOUTH PLAINFIELD, N.J., April 30, 2020 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the first quarter ending March 31, 2020.
  • Due to the uncertainty of the duration and severity of the COVID-19 impact, PTC is withdrawing financial guidance for the 2020 fiscal year.
  • PTC now anticipates results from the U.S. Translarna dystrophin study in the third quarter of 2020.
  • In this press release, the financial results of PTC are provided in accordance with GAAP and using certain non-GAAP financial measures.

BriaCell Doses First Patient in Phase I/IIa Study Evaluating Bria-IMT™ in Combination with INCMGA00012 and Epacadostat in Patients with Advanced Breast Cancer

Retrieved on: 
Monday, October 7, 2019
Chemical compounds, Breast cancer, Epacadostat, Oxadiazoles, Incyte, Metastatic breast cancer, Organic compounds, Clinical medicine

Patient dosing has begun in the Phase I/IIa study evaluating the anti-tumor effects of BriaCells lead candidate, Bria-IMT in combination with Incytes INCMGA00012 and epacadostat in patients with advanced breast cancer.

Key Points: 
  • Patient dosing has begun in the Phase I/IIa study evaluating the anti-tumor effects of BriaCells lead candidate, Bria-IMT in combination with Incytes INCMGA00012 and epacadostat in patients with advanced breast cancer.
  • A subsequent group of patients will be treated with the triple combination of the Bria-IMT with INCMGA00012 and epacadostat.
  • The starting dose of epacadostat has been established to be safe when given in combination with INCMGA00012 in patients with cancer.
  • Phase I/IIa clinical trial is an open-label, multi-center study to evaluate the safety and efficacy of Bria-IMT in combination with INCMGA00012, and epacadostat in patients with advanced breast cancer.

Isentress - API Insight, 2019 - ResearchAndMarkets.com

Retrieved on: 
Friday, May 31, 2019
Health, Pharmaceutical, Chemical compounds, Integrase inhibitors, Merck, Organic compounds, Oxadiazoles, RTT, Raltegravir, Application programming interface, Web API, Chemistry

The "Isentress - API Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Isentress - API Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • Isentress - API Insight, 2019 provides product and API manufacturers' details across the globe along with the location.
  • The report gives the clear idea on the country wise DMF filed by worldwide companies related to Isentress.
  • The report also highlights the patent details of Isentress.

Shionogi Concludes a Contract for the Commercialization of Rizmoic® (naldemedine), an Opioid-Induced Constipation Therapeutic Agent, in Germany, the UK, and the Netherlands

Retrieved on: 
Thursday, April 11, 2019
Health, Pharmaceutical, Research, Science, Drugs, Chemical compounds, Opioid antagonists, Medicine, Cyclopropanes, Morphinans, Naldemedine, Opioids, Oxadiazoles, Shionogi, Opioid, Placebo

According to this contract, Sandoz will commercialize Rizmoic in Germany, the UK, and the Netherlands, and Shionogi will be responsible for its manufacturing and development.

Key Points: 
  • According to this contract, Sandoz will commercialize Rizmoic in Germany, the UK, and the Netherlands, and Shionogi will be responsible for its manufacturing and development.
  • We therefore expect Rizmoic to contribute significantly to OIC treatment in clinical settings in European countries in the future.
  • Rizmoic is a peripherally acting mu-opioid receptor antagonist (PAMORA) that has been developed by Shionogi as a once-daily treatment of OIC.
  • Efficacy and tolerability of naldemedine in patient with cancer and opioidinduced constipation: A pooled subgroup analysis of 2 randomised placebo-controlled studies.

Shionogi Announces Licensing of Symproic® (naldemedine) to BioDelivery Sciences International Inc.

Retrieved on: 
Wednesday, April 10, 2019
Health, Biotechnology, Clinical trials, Pharmaceutical, Managed care, Chemical compounds, Drugs, Organic compounds, RTT, Opioid antagonists, Opioids, Morphinans, Naldemedine, Oxadiazoles, Shionogi, Itraconazole, Opioid

Shionogi Inc. (hereafter "Shionogi") announced today that BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic pain, has licensed full rights to commercialize Symproic (naldemedine) tablets 0.2 mg in the United States.

Key Points: 
  • Shionogi Inc. (hereafter "Shionogi") announced today that BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic pain, has licensed full rights to commercialize Symproic (naldemedine) tablets 0.2 mg in the United States.
  • Use with moderate (e.g., fluconazole) and strong (e.g., itraconazole) CYP3A inhibitors and P-glycoprotein inhibitors (e.g., cyclosporine) may increase Symproic concentrations.
  • Avoid use of Symproic with another opioid antagonist due to potential for additive effect and increased risk of opioid withdrawal.
  • About BioDelivery Sciences International Inc.
    BioDelivery Sciences International, Inc.(NASDAQ: BDSI) is a rapidly growing commercial-stage specialty pharmaceutical company dedicated to patients living with chronic pain.