Pyridines

Janssen Presents Results from Phase 3 ACIS Study in Patients with Metastatic Castration-Resistant Prostate Cancer Treated with Apalutamide▼ and Abiraterone Acetate Combination

Retrieved on: 
Tuesday, February 9, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Organic compounds, Chemical compounds, Prostate cancer, Chemistry, Pyridines, Androstanes, CYP17A1 inhibitors, Steroidal antiandrogens, Abiraterone acetate, Apalutamide, MCRPC, Nicholas J. Vogelzang, Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Organic compounds, Chemical compounds, Prostate cancer, Chemistry, Pyridines, Androstanes, CYP17A1 inhibitors, Steroidal antiandrogens, Abiraterone acetate, Apalutamide, MCRPC, Nicholas J. Vogelzang, the ACIS Study, Metastatic Castration-Resistant Prostate Cancer, apalutamide, abiraterone acetate, Janssen Pharmaceutical Companies of Johnson & Johnson

The safety profile was consistent with prior studies of apalutamide, with no new safety signals observed.

Key Points: 
  • The safety profile was consistent with prior studies of apalutamide, with no new safety signals observed.
  • ACIS is a Phase 3 randomised, double-blind, placebo-controlled, multicentre clinical study evaluating the efficacy and safety of apalutamide and abiraterone acetate plus prednisone compared to placebo and abiraterone acetate plus prednisone in 982 patients with chemotherapy-nave mCRPC disease who received ADT.1 Patients were randomised to receive either apalutamide and abiraterone acetate plus prednisone, or placebo and abiraterone acetate plus prednisone.
  • Dana E. Final Results From ACIS, a Randomized, Placebo (PBO)-Controlled Double-Blind Phase 3 Study of Apalutamide (APA) and Abiraterone Acetate Plus Prednisone (AAP) Versus AAP in Patients (Pts) With Chemo-Naive Metastatic Castration-Resistant Prostate Cancer (mCRPC).
  • ZYTIGA (abiraterone acetate) Plus Prednisone Approved for Treatment of Earlier Form of Metastatic Prostate Cancer.

Janssen Announces Treatment with ERLEADA®▼(apalutamide) Significantly Improved Overall Survival in Patients with Metastatic Hormone-Sensitive Prostate Cancer

Retrieved on: 
Tuesday, February 9, 2021
Oncology, Health, Clinical trials, General Health, Pharmaceutical, Biotechnology, Organic compounds, Chemical compounds, Chemistry, Prostate cancer, Nonsteroidal antiandrogens, Progonadotropins, Pyridines, Spiro compounds, Apalutamide, the TITAN Study, Metastatic Hormone-Sensitive Prostate Cancer, apalutamide, Janssen Pharmaceutical Companies of Johnson & Johnson

The results of the TITAN final analysis demonstrate that apalutamide with ADT provides a new therapeutic option for people living with advanced, hormone-sensitive prostate cancer.

Key Points: 
  • The results of the TITAN final analysis demonstrate that apalutamide with ADT provides a new therapeutic option for people living with advanced, hormone-sensitive prostate cancer.
  • The results also demonstrate an established safety profile which is encouraging for the management of patients living with advanced forms of prostate cancer.
  • The study included 1,052 patients in 23 countries across 260 sites in North America, Latin America, South America, Europe, and Asia Pacific.
  • Patients with mHSPC were randomised 1:1 and received either apalutamide (240 mg) plus ADT (n=525), or placebo plus ADT (n=527).

DGAP-News: PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS

Retrieved on: 
Thursday, January 28, 2021
Drugs, Chemical compounds, Organic compounds, GABAA receptor positive allosteric modulators, Anesthesia, Benzodiazepines, Pyridines, Remimazolam, General anesthetics, Sedation, Procedural sedation and analgesia, Ketamine, remimazolam, PAION

PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS

Key Points: 
  • PAION AG: ACACIA PHARMA LAUNCHES BYFAVO(TM) (REMIMAZOLAM) IN THE U.S. FOR PROCEDURAL SEDATION IN ADULTS UNDERGOING MEDICAL PROCEDURES LASTING 30 MINUTES OR LESS
    The issuer is solely responsible for the content of this announcement.
  • BYFAVO(TM) was approved by the U.S. Food and Drug Administration (FDA) on 2 July 2020 for the induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less.
  • Remimazolam is approved in the U.S. and China for procedural sedation and in Japan and South Korea for general anesthesia.
  • In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019.

Addex ADX71149 Receives IND Approval to Start a Phase 2a Clinical Study in Epilepsy

Retrieved on: 
Thursday, January 21, 2021
Drugs, Chemical compounds, Pyridines, Organic compounds, ADX-71149, Chloroarenes, Lactams, Metabotropic glutamate receptor 2, Levetiracetam, Allosteric modulator

IND approval for the mGlu2 epilepsy study is great news to start 2021 and will be the first of three clinical studies we expect to be initiate this year, said Tim Dyer, CEO of Addex.

Key Points: 
  • IND approval for the mGlu2 epilepsy study is great news to start 2021 and will be the first of three clinical studies we expect to be initiate this year, said Tim Dyer, CEO of Addex.
  • Wed like to thank the team involved for their continued support and moving quickly to get this clinical study ready for patient enrolment.
  • The primary objective of the study is to evaluate the efficacy of JNJ-40411813 (ADX71149) in combination with levetiracetam using a time-to-event endpoint.
  • Addex's third clinical program, ADX71149 (mGlu2 positive allosteric modulator or PAM), developed in collaboration with Janssen Pharmaceuticals, Inc, is scheduled to enter a phase 2a proof of concept clinical study for the treatment of epilepsy in Q2 2021.

First Patients Tested with InVisionFirst®-Lung in EORTC Sponsored Phase II NSCLC Study

Retrieved on: 
Wednesday, January 20, 2021
Chemical compounds, Tyrosine kinase receptors, Orphan drugs, Lung cancer, Organic compounds, Lactams, Lorlatinib, Pyridines, Anaplastic lymphoma kinase, European Organisation for Research and Treatment of Cancer, Non-small-cell lung carcinoma, ALK inhibitor

The aim of this academic trial, announced in 2019 and being supported by Pfizer, is to examine the resistance to lorlatinib in ALK positive NSCLC patients.

Key Points: 
  • The aim of this academic trial, announced in 2019 and being supported by Pfizer, is to examine the resistance to lorlatinib in ALK positive NSCLC patients.
  • While in the past these patients were known to respond well to ALK inhibition therapies, such as lorlatinib, drug resistance in patients has been increasing.
  • A total of 100 patients will be involved in two study designs run in parallel across 30 participating EORTC sites across Europe.
  • The Phase II study is a single arm, multicenter study.

Tenax Therapeutics, Inc. Announces Transformative Acquisition of PH Precision Med

Retrieved on: 
Tuesday, January 19, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Cardiology, Piperazines, Imatinib, Pyridines, Clinical medicine, Pulmonary hypertension, Medicine, Tenax, Cycle racing, Levosimendan, Imatinib

The acquisition expands Tenaxs pulmonary hypertension pipeline with the addition of imatinib, a Phase 3 ready candidate.

Key Points: 
  • The acquisition expands Tenaxs pulmonary hypertension pipeline with the addition of imatinib, a Phase 3 ready candidate.
  • Stuart Rich, MD, co-founder of PHDM, has been appointed Chief Medical Officer of Tenax Therapeutics.
  • Mr. DiTonno continued, In addition to this transformative asset, we are also pleased to welcome PHPMs co-founder Dr. Rich to the Tenax management team.
  • I look forward to joining the Tenax team to unlock the clinical potential of imatinib for patients with severe PAH.

ESSA Pharma Announces Clinical Collaboration with Janssen to Evaluate EPI-7386 Combination for Patients with Metastatic Castration-Resistant Prostate Cancer

Retrieved on: 
Wednesday, January 13, 2021
Organic compounds, Chemical compounds, Organ systems, Nonsteroidal antiandrogens, Pyridines, Progonadotropins, Anti-acne preparations, Apalutamide, Antiandrogen, Abiraterone acetate, Prostate cancer, EPI-7386

"We are delighted to collaborate with Janssen to explore the potential clinical role of EPI-7386 in combination with the antiandrogens apalutamide and abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer," said Dr. David.

Key Points: 
  • "We are delighted to collaborate with Janssen to explore the potential clinical role of EPI-7386 in combination with the antiandrogens apalutamide and abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer," said Dr. David.
  • We look forward to investigating these combination therapies and their potential to improve the treatment of prostate cancer."
  • ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer.
  • Prostate cancer is the second-most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide (Globocan, 2018).

LORBRENA® (lorlatinib) sNDA in Previously Untreated ALK-Positive Lung Cancer Accepted for Priority Review by U.S. FDA

Retrieved on: 
Monday, December 28, 2020
Oncology, FDA, Health, Clinical trials, Pharmaceutical, Biotechnology, Chemical compounds, Health, GABAA receptor positive allosteric modulators, Pyridines, Food and Drug Administration, United States Public Health Service, Cholesterol, Clinical trial, Niacin, Lorlatinib, the CROWN Study, Non-Small Cell Lung Cancer, LORBRENA® (lorlatinib), XALKORI® (crizotinib), Pfizer Oncology

The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program.

Key Points: 
  • The sNDA is based on data from the pivotal CROWN study and is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program.
  • The program allows the FDA to review clinical trial data from certain applications before the complete application is formally submitted.
  • Depending upon the relative importance of each drug, discontinue LORBRENA or the CYP3A inducer for persistent Grade 2 or higher hepatotoxicity.
  • Monitor serum cholesterol and triglycerides before initiating LORBRENA, 1 and 2 months after initiating LORBRENA, and periodically thereafter.

Iterum Therapeutics Announces Transition of Michael Dunne, M.D. to Strategic Advisor and Member of the Board of Directors

Retrieved on: 
Wednesday, December 23, 2020
Antibiotics, Pyridines, Pyrrolidines

Dr. Dunne has also been elected to the Companys Board of Directors, effective as of December 22, 2020.

Key Points: 
  • Dr. Dunne has also been elected to the Companys Board of Directors, effective as of December 22, 2020.
  • Mike has been instrumental in the development of sulopenem, and we thank him for his many contributions to date.
  • Iterum Therapeutics is advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation and IV formulation.
  • Iterum Therapeutics has received Qualified Infectious Disease Product (QIDP) and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Global Pyridine & Pyridine Derivatives Market to 2027 with Pyridine Segment Projected to Account for $358.9 Million of the $822.9 Mn Total Market - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 22, 2020
Chemicals, Plastics, Manufacturing, Chemical compounds, Aromatic compounds, Organic compounds, Pyridines, Pyridine, Picoline, Market

Pyridine and Pyridine Derivatives Global Market Estimates and Forecasts in US$ Thousand by Region/Country: 2020-2027

Key Points: 
  • Pyridine and Pyridine Derivatives Global Market Estimates and Forecasts in US$ Thousand by Region/Country: 2020-2027
    Pyridine and Pyridine Derivatives Global Retrospective Market Scenario in US$ Thousand by Region/Country: 2012-2019
    Pyridine and Pyridine Derivatives Market Share Shift across Key Geographies Worldwide: 2012 VS 2020 VS 2027
    Pyridine (Type) World Market by Region/Country in US$ Thousand: 2020 to 2027
    Pyridine (Type) Historic Market Analysis by Region/Country in US$ Thousand: 2012 to 2019
    Pyridine (Type) Market Share Breakdown of Worldwide Sales by Region/Country: 2012 VS 2020 VS 2027
    Beta Picoline (Type) Potential Growth Markets Worldwide in US$ Thousand: 2020 to 2027
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    Agrochemicals (Application) Global Market Share Distribution by Region/Country for 2012, 2020, and 2027
    Pharmaceuticals (Application) Global Opportunity Assessment in US$ Thousand by Region/Country: 2020-2027
    Pharmaceuticals (Application) Historic Sales Analysis in US$ Thousand by Region/Country: 2012-2019
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    Latexes (Application) Worldwide Sales in US$ Thousand by Region/Country: 2020-2027
    Latexes (Application) Historic Demand Patterns in US$ Thousand by Region/Country: 2012-2019
    Latexes (Application) Market Share Shift across Key Geographies: 2012 VS 2020 VS 2027
    Food (Application) Global Market Estimates & Forecasts in US$ Thousand by Region/Country: 2020-2027
    Food (Application) Retrospective Demand Analysis in US$ Thousand by Region/Country: 2012-2019
    Food (Application) Market Share Breakdown by Region/Country: 2012 VS 2020 VS 2027
    Other Applications (Application) Demand Potential Worldwide in US$ Thousand by Region/Country: 2020-2027
    Other Applications (Application) Historic Sales Analysis in US$ Thousand by Region/Country: 2012-2019
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