Pyridines

Novartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trial

Retrieved on: 
Tuesday, December 8, 2020
Chemical compounds, Organic compounds, Drugs, Orphan drugs, Piperazines, Chronic myeloid leukemia, Pyridines, Chronic myelogenous leukemia, Imidazoles, Dasatinib, Philadelphia chromosome, Nilotinib

Our ongoing research in Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) has helped transform the disease from a fatal leukemia to a chronic condition in most patients.

Key Points: 
  • Our ongoing research in Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) has helped transform the disease from a fatal leukemia to a chronic condition in most patients.
  • Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results.
  • Combination of Asciminib Plus Nilotinib (NIL) or Dasatinib (DAS) in Patients (PTS) with Chronic Myeloid Leukemia (CML): Results from a Phase 1 Study.
  • Combination Therapy Using Asciminib Plus Imatinib (IMA) in Patients (PTS) with Chronic Myeloid Leukemia (CML): Results from a Phase 1 Study.

Eisai Presents Long-Term Seizure Freedom And Real-World Data Related To Anti-Epileptic Drug FYCOMPA® At The AES 2020 Annual Meeting

Retrieved on: 
Monday, December 7, 2020
Epilepsy, Anticonvulsants, Nitriles, Perampanel, Pyridines, Seizure, Eisai, AED, Clinical medicine, Branches of biology, Medicine

WOODCLIFF LAKE, N.J., Dec. 7, 2020 /PRNewswire/ --Eisai Inc. presented 52-week seizure freedom data related to its antiepileptic drug (AED) FYCOMPA (perampanel) CIII at the 2020 American Epilepsy Society (AES) Annual Meeting virtual conference.

Key Points: 
  • WOODCLIFF LAKE, N.J., Dec. 7, 2020 /PRNewswire/ --Eisai Inc. presented 52-week seizure freedom data related to its antiepileptic drug (AED) FYCOMPA (perampanel) CIII at the 2020 American Epilepsy Society (AES) Annual Meeting virtual conference.
  • Effectiveness assessments comprised seizure freedom rate, responder rate, and the proportion of patients with unchanged or worsening seizure frequency.
  • The results are encouraging as we continue to work toward the goal of seizure freedom for patients taking antiepileptic drug therapy."
  • The seizure freedom rate was 62.5% in the mITT population (n=20/32) at 4 mg/day for 52 weeks.

RedHill Biopharma Extends Talicia® Unrestricted National and Regional Commercial Coverage to Over 40 Million Additional Americans

Retrieved on: 
Monday, December 7, 2020
Drugs, Chemical compounds, Organic compounds, Benzimidazoles, Proton pump inhibitors, Pyridines, Sulfoxides, Omeprazole, Rifabutin, Tel Aviv, Raleigh, North Carolina

TEL AVIV, Israel and RALEIGH, N.C., Dec. 7, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has increased unrestricted national and regional commercial coverage for Talicia (omeprazole magnesium, amoxicillin and rifabutin)[1] to more than 40 million additional Americans.

Key Points: 
  • TEL AVIV, Israel and RALEIGH, N.C., Dec. 7, 2020 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has increased unrestricted national and regional commercial coverage for Talicia (omeprazole magnesium, amoxicillin and rifabutin)[1] to more than 40 million additional Americans.
  • "With this addition of unrestricted coverage for over 40 million more lives, Talicia is now available to over 70% of commercial lives.
  • The unrestricted commercial coverage achieved for Talicia to date far exceeds our expectations at such an early stage following the product's launch.
  • This growth in unrestricted commercial access helps change that dynamic by increasing access to Talicia to more than 167 million Americans."

Kura Oncology Presents First Clinical Data for Menin Inhibitor KO-539 at American Society of Hematology Annual Meeting

Retrieved on: 
Saturday, December 5, 2020
Cancer treatments, Lactams, Chemotherapy, Clinical medicine, Antibody-drug conjugates, Antineoplastic drugs, Orphan drugs, Lestaurtinib, Pyridines

These data are being presented during an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.

Key Points: 
  • These data are being presented during an oral session at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition.
  • I am delighted to observe evidence of clinical activity in patients with diverse genetic backgrounds, including patients with NPM1 mutations.
  • The preliminary clinical data for KO-539 suggest it has the potential to be effective for multiple genetically defined AML subgroups of high unmet need.
  • KOMET-001 (Kura Oncology Menin Inhibitor Trial) is a Phase 1/2A clinical trial to determine the safety, tolerability and recommended Phase 2 dose of KO-539 in patients with refractory or relapsed AML.

Sermonix to Present Poster on Phase 2 Study of Lasofoxifene in Combination with Eli Lilly and Company’s Abemaciclib at Virtual San Antonio Breast Cancer Symposium 2020

Retrieved on: 
Thursday, December 3, 2020
Chemical compounds, Organic compounds, Aromatic compounds, Protein kinase inhibitors, Abemaciclib, Benzimidazoles, Breakthrough therapy, Piperazines, Pyridines, Lasofoxifene, Eli Lilly and Company, HER2/neu

It is assessing the safety and tolerability of lasofoxifene in combination with abemaciclib for treating women with locally advanced or metastatic ER+/HER2- breast cancer and an ESR1 mutation.

Key Points: 
  • It is assessing the safety and tolerability of lasofoxifene in combination with abemaciclib for treating women with locally advanced or metastatic ER+/HER2- breast cancer and an ESR1 mutation.
  • Sermonix is partnering with Tempus, a data-driven, precision-medicine technology company, to identify and enroll ELAINE 2 participants through genomic biomarker testing.
  • Sermonix is delighted to share a poster at SABCS 2020 highlighting the study in our collaboration with Eli Lilly and Company, said Dr. Paul Plourde.
  • Sermonix non-executive chairman of the board is Anthony Wild, Ph.D., former president of both Parke-Davis Pharmaceuticals and Warner-Lamberts Pharmaceutical Division.

Cara Therapeutics Completes Full Enrollment in KARE Phase 2 Trial of Oral KORSUVA™ in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus

Retrieved on: 
Wednesday, December 2, 2020
Chemical compounds, Steroids, Organic compounds, Atopic dermatitis, Type I hypersensitivity, Monoclonal antibodies, Pyridines, Ethers, Tradipitant, Tralokinumab

Full enrollment of the KARE Phase 2 trial on schedule represents an important milestone for the clinical development of Oral KORSUVA.

Key Points: 
  • Full enrollment of the KARE Phase 2 trial on schedule represents an important milestone for the clinical development of Oral KORSUVA.
  • Pruritus treatment continues to be a significant unmet need for patients with atopic dermatitis and we believe Oral KORSUVA has the potential to be a first-in-class oral anti-pruritic product with a favorable safety profile.
  • The KARE Phase 2 trial is a randomized, double-blind, placebo-controlled study that is designed to evaluate the efficacy and safety of Oral KORSUVA for moderate-to-severe pruritus in approximately 400 adult subjects with atopic dermatitis.
  • Oral KORSUVA has successfully completed a Phase 2 trial for the treatment of pruritus in patients with CKD and is currently in Phase 2 trials in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.

Deciphera Pharmaceuticals Completes Target Enrollment in the INTRIGUE Phase 3 Clinical Study of QINLOCK® (Ripretinib) in Patients with Second-Line Gastrointestinal Stromal Tumor

Retrieved on: 
Monday, November 30, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Health sciences, Clinical medicine, Cancer treatments, Pyridines, Orphan drugs, Indoles, Pyrroles, Sunitinib, Ripretinib, Gastrointestinal stromal tumor, Imatinib, QINLOCK (ripretinib), GIST, Deciphera Pharmaceuticals

Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK in patients with second-line gastrointestinal stromal tumor (GIST).

Key Points: 
  • Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) today announced the completion of its target enrollment in the INTRIGUE Phase 3 clinical study evaluating the efficacy and safety of QINLOCK in patients with second-line gastrointestinal stromal tumor (GIST).
  • The INTRIGUE Phase 3 clinical study is a randomized, global, multicenter, open-label study to evaluate the efficacy and safety of QINLOCK compared to sunitinib in patients with GIST previously treated with imatinib.
  • This study was designed to support regulatory approvals in second-line GIST patients in the United States, Europe, and other major markets.
  • QINLOCK and the QINLOCK logo are registered trademarks, and Deciphera, Deciphera Pharmaceuticals, and the Deciphera logo are trademarks, of Deciphera Pharmaceuticals, LLC.

DGAP-News: PAION REPORTS POSITIVE REMIMAZOLAM TOPLINE DATA IN EU PHASE III TRIAL IN GENERAL ANESTHESIA

Retrieved on: 
Thursday, November 19, 2020
Chemical compounds, Medical specialties, GABAA receptor positive allosteric modulators, Organic compounds, Benzodiazepines, Pyridines, Remimazolam, General anesthetics, Propofol, Sedation, Procedural sedation and analgesia, Anesthesia

- Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol

Key Points: 
  • - Key secondary endpoint met: remimazolam demonstrated superior hemodynamic stability compared to propofol
    - EU Phase III program completed; data to serve as basis for MAA submission in general anesthesia
    Aachen (Germany), 19 November 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces positive topline data from the pivotal remimazolam EU Phase III trial in general anesthesia.
  • Assuming approval in procedural sedation, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia.
  • In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
  • In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation.

Poxel Presents Phase 1b Clinical Results for PXL065 and New Preclinical Data for PXL770 at AASLD The Liver Meeting® 2020

Retrieved on: 
Monday, November 16, 2020
Research, Diabetes, Clinical trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Health sciences, Health, Clinical research, Drug discovery, Pharmaceutical industry, Pyridines, Design of experiments, Life sciences, Pioglitazone, Clinical trial, NASH, PXL770, PXL065, Poxel SA

Further analysis from our Phase 1b clinical study highlights dose-equivalence for 15 mg of PXL065 vs. 45 mg of Actos.

Key Points: 
  • Further analysis from our Phase 1b clinical study highlights dose-equivalence for 15 mg of PXL065 vs. 45 mg of Actos.
  • On the heels of positive, topline Phase 2a results, these additional data support the continued development of PXL770.
  • Additionally, across several clinical parameters and preclinical studies, PXL770 has demonstrated broader potential in other chronic metabolic indications.
  • Based upon preclinical and Phase 1 results to date, Poxel believes that PXL065 may have a better therapeutic profile than pioglitazone for NASH.

DGAP-News: PAION AG PUBLISHES GROUP QUARTERLY STATEMENT FOR THE FIRST NINE MONTHS OF 2020

Retrieved on: 
Wednesday, November 11, 2020
Drugs, Psychoactive drugs, Chemical compounds, GABAA receptor positive allosteric modulators, Benzodiazepines, Pyridines, Remimazolam, General anesthetics, Euphoriants, Sedation, Food and Drug Administration, Drug Enforcement Administration

In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.

Key Points: 
  • In the U.S., the FDA (Food & Drug Administration) granted market approval of BYFAVOTM (remimazolam) for procedural sedation in July 2020.
  • In October 2020, the Drug Enforcement Administration (DEA) designated BYFAVO(TM) as a Schedule IV medicine, which was a prerequisite for launch.
  • The overall evaluation of opportunities and risks has not changed significantly in the first nine months of 2020.
  • PAION confirms its financial outlook for the current fiscal year announced on 12 August 2020 with the publication of the half-year results for 2020.