Nitriles

New England Journal of Medicine Publishes Final Data for NUBEQA® (darolutamide) Plus Androgen Deprivation Therapy Showing a Statistically Significant Improvement in Overall Survival in Men with Non-Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Wednesday, September 9, 2020

In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or ADT alone.

Key Points: 
  • In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily or ADT alone.
  • Serious adverse reactions occurred in 25% of patients receiving NUBEQA and in 20% of patients receiving placebo.
  • Serious adverse reactions in 1 % of patients who received NUBEQA were urinary retention, pneumonia, and hematuria.
  • Effects of NUBEQA on Other Drugs NUBEQA is an inhibitor of breast cancer resistance protein (BCRP) transporter.

Tenax Announces Late-Breaking Results from the HELP Study Accepted for Presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting

Retrieved on: 
Monday, August 31, 2020

Detailed results of the HELP Study will be presented as a late-breaking oral abstract by Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic and a member of the HELP Study Steering Committee.

Key Points: 
  • Detailed results of the HELP Study will be presented as a late-breaking oral abstract by Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic and a member of the HELP Study Steering Committee.
  • Tenax CEO Anthony DiTonno stated We are very excited to have the HELP Study results accepted for presentation as a late-breaking abstract at the HFSA Annual Meeting.
  • The positive results of the HELP Study represent a major milestone for Tenax and our development of levosimendan for the treatment of patients suffering from this debilitating illness.
  • The primary endpoint of the HELP Trial is based on change in PCWP vs baseline compared to placebo.

Global Acetonitrile Market Forecast to 2027 - COVID-19 Impact and Analysis - ResearchAndMarkets.com

Retrieved on: 
Friday, August 21, 2020

The "Acetonitrile Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Type; by Application and Geography" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Acetonitrile Market Forecast to 2027 - COVID-19 Impact and Global Analysis by Type; by Application and Geography" report has been added to ResearchAndMarkets.com's offering.
  • The global acetonitrile market accounted for US$ 236.18 Mn in 2018 and is expected to grow at a CAGR of 5.1% from 2019 to 2027, to reach US$ 368.60 Mn by 2027.
  • In 2018, the pharmaceuticals segment dominated the acetonitrile market in 2018, and it is projected to exhibit the highest CAGR in the market during the forecast period.
  • Features key findings and crucial progressive industry trends in the global acetonitrile market, thereby allowing players to develop effective long-term strategies.

FDA approves Novartis Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

Retrieved on: 
Thursday, August 20, 2020

* Additional regulatory filings are currently underway across the world, and regulatory approval for Kesimpta in Europe is expected by Q2 2021.

Key Points: 
  • * Additional regulatory filings are currently underway across the world, and regulatory approval for Kesimpta in Europe is expected by Q2 2021.
  • KESIMPTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting disease, and active secondary progressive disease.
  • Ofatumumab versus teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials.
  • Ofatumumab versus teriflunomide in relapsing multiple sclerosis: baseline characteristics of two pivotal phase 3 trials (ASCLEPIOS I and ASCLEPIOS II).

U.S. FDA Approves Kesimpta® (ofatumumab) in Relapsing Multiple Sclerosis

Retrieved on: 
Thursday, August 20, 2020

Kesimpta (ofatumumab) approved by U.S. FDA for the treatment of relapsing forms of multiple sclerosis in adults

Key Points: 
  • Kesimpta (ofatumumab) approved by U.S. FDA for the treatment of relapsing forms of multiple sclerosis in adults
    Copenhagen, Denmark; August 20, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of Kesimpta (ofatumumab) injection for subcutaneous use, for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
  • This is a significant day for patients in the U.S. with relapsing multiple sclerosis, who will now have Kesimpta as an efficacious and convenient treatment option.
  • Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis (ASCLEPIOS I).
  • Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis.

Tenax Therapeutics Reports Second Quarter 2020 Results and Provides Business Update

Retrieved on: 
Monday, August 17, 2020

Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today reported financial results for the second quarter 2020 and provided a business update.

Key Points: 
  • Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today reported financial results for the second quarter 2020 and provided a business update.
  • In June 2020, Tenax reported positive data from its recently completed Phase 2 HELP trial of levosimendan in patients with PH-HFpEF.
  • Research and development expenses for the second quarter of 2020 were $1.3 million, compared to $650,000 for the second quarter of 2019.
  • General and administrative expenses for the second quarter of 2020 were $870,000, compared to $1.2 million for the second quarter of 2019.

ORIC Pharmaceuticals Expands Precision Oncology Pipeline with Exclusive Worldwide License to Highly Selective Allosteric PRC2 Inhibitors from Mirati Therapeutics

Retrieved on: 
Wednesday, August 5, 2020

With ORICs focus on novel treatments for prostate cancer, ORIC is an ideal partner to further the research and development of this program.

Key Points: 
  • With ORICs focus on novel treatments for prostate cancer, ORIC is an ideal partner to further the research and development of this program.
  • Prior to entering into the license agreement with Mirati, ORIC generated compelling in vivo efficacy data in enzalutamide-resistant prostate cancer models with ORIC-944.
  • More recent scientific advances have focused on developing allosteric inhibitors of PRC2, which may help to address several limitations of first-generation PRC2 inhibitors.
  • Research conducted at ORIC demonstrated that allosteric inhibitors of PRC2 are more efficacious in treatment-resistant prostate cancer models than has been reported by traditional non-allosteric PRC2 inhibitors.

Global Castrate-resistant Prostate Cancer (CRPC) Market 2017-2030 - Epidemiology, Pipeline, Drugs, Reimbursement Scenario, Competitive Intelligence - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 28, 2020

The "Castrate-resistant Prostate Cancer (CRPC) -Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Castrate-resistant Prostate Cancer (CRPC) -Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • Erleada (apalutamide) is a next-generation oral androgen receptor (AR) inhibitor that blocks the androgen signaling pathway in prostate cancer cells.
  • It is indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).
  • AR over-expression in prostate cancer represents a key mechanism associated with prostate cancer hormone resistance.

Sierra Oncology Appoints Christina Thomson as General Counsel

Retrieved on: 
Tuesday, July 28, 2020

VANCOUVER, British Columbia, July 28, 2020 (GLOBE NEWSWIRE) -- Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, today announced the appointment of Christina Thomson as General Counsel.

Key Points: 
  • VANCOUVER, British Columbia, July 28, 2020 (GLOBE NEWSWIRE) -- Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on the registration and commercialization of momelotinib, a JAK1, JAK2 & ACVR1 inhibitor with a potentially differentiated therapeutic profile for the treatment of myelofibrosis, today announced the appointment of Christina Thomson as General Counsel.
  • Christina is a highly effective General Counsel with a wealth of business and legal expertise, including corporate and competitive strategy, licensing, and commercialization planning.
  • Christina Thomson is a seasoned legal executive who has served as General Counsel for several public, private and non-profit life sciences companies, including Athira Pharma, Infectious Disease Research Institute, APT Pharmaceuticals and Avigen, in addition to representing clients in private practice.
  • Sierra Oncology granted an equity award on July 28, 2020 to Christina Thomson as a material inducement to her employment as General Counsel with the Company.

National Institutes of Health Selects Humanigen’s Lenzilumab for its COVID-19 Big Effect Trial

Retrieved on: 
Monday, July 27, 2020

This trial builds on initial data from NIAIDs Adaptive COVID-19 Treatment Trial (ACTT) that demonstrated Gileads investigational antiviral, remdesivir, may improve time to recovery in hospitalized patients with COVID-19.

Key Points: 
  • This trial builds on initial data from NIAIDs Adaptive COVID-19 Treatment Trial (ACTT) that demonstrated Gileads investigational antiviral, remdesivir, may improve time to recovery in hospitalized patients with COVID-19.
  • BET will evaluate the combination of lenzilumab and remdesivir on treatment outcomes versus placebo and remdesivir in hospitalized COVID-19 patients.
  • We have been encouraged by the lenzilumab efficacy and safety data demonstrated in the compassionate use series in COVID-19 patients and are thrilled that NIH selected lenzilumab to be part of its Big Effect Trial, said Cameron Durrant, MD, MBA, chief executive officer of Humanigen.
  • With data from the BET and our ongoing Phase III study, we will have data from approximately 500 hospitalized COVID-19 patients.