Morpholines

Athenex Announces European Commission Approval of Klisyri® (tirbanibulin) for the Topical Treatment of Actinic Keratosis

Retrieved on: 
Monday, July 19, 2021
Chemical compounds, Organic compounds, Amides, Ethers, Morpholines, Pyridines, Tirbanibulin, Chemistry, Actinic keratosis, Almirall, AK

This approval by the European Commission marks another significant milestone for Klisyri, shortly following the marketing approval and launch of Klisyri in the U.S., said Dr. Johnson Lau, Chief Executive Officer of Athenex.

Key Points: 
  • This approval by the European Commission marks another significant milestone for Klisyri, shortly following the marketing approval and launch of Klisyri in the U.S., said Dr. Johnson Lau, Chief Executive Officer of Athenex.
  • In December 2020, Athenex received approval from the U.S. Food and Drug Administration (FDA) for the commercialization of Klisyri (tirbanibulin) in the U.S. for the topical treatment of AK of the face or scalp.
  • Our partner Almirall led the U.S. launch of Klisyri in February and is leading the launch of Klisyri in Europe.
  • Klisyri (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis (AK) of the face or scalp.

Almirall receives European Commission approval of Klisyri® (tirbanibulin), an innovative topical treatment for actinic keratosis

Retrieved on: 
Monday, July 19, 2021
Chemistry, Chemical compounds, Physical sciences, Amides, Ethers, Morpholines, Pyridines, Tirbanibulin, Actinic keratosis, Almirall, Keratosis, AK

BARCELONA, Spain, July 19, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults.

Key Points: 
  • BARCELONA, Spain, July 19, 2021 /PRNewswire/ -- Almirall S.A. (BME: ALM), a global biopharmaceutical company, announced today that the European Commission (EC) has approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp in adults.
  • "The approval of Klisyrirepresents a breakthrough for actinic keratosis patients, who seek for new treatments that could offer them a better tolerability and short treatment duration.
  • In addition, Almirall has submitted Klisyri for a marketing authorisation in Switzerland in Q4 2020 and the dossier is currently under review by Swissmedic.
  • [4]Chetty P, Choi F, Mitchell T. Primary care review of actinic keratosis and its therapeutic options: a global perspective.

BeiGene Announces the Approval in China of KYPROLIS® (Carfilzomib) for Injection for Adult Patients with Relapsed or Refractory Multiple Myeloma

Retrieved on: 
Friday, July 9, 2021
Pharmaceutical, Health, Other Health, Drugs, Orphan drugs, Clinical medicine, Chemical compounds, Carfilzomib, Epoxides, Morpholines, Peptides, Multiple myeloma, Proteasome inhibitor, Breakthrough therapy, Daratumumab, Multiple Myeloma, KYPROLIS® (carfilzomib) for injection, BeiGene, MULTIPLE MYELOMA, KYPROLIS® (CARFILZOMIB) FOR INJECTION, BEIGENE

The approval of KYPROLIS provides us with an important opportunity to offer adult patients in China with relapsed or refractory multiple myeloma a proteasome inhibitor with high selectivity and irreversibility as a treatment option for their disease.

Key Points: 
  • The approval of KYPROLIS provides us with an important opportunity to offer adult patients in China with relapsed or refractory multiple myeloma a proteasome inhibitor with high selectivity and irreversibility as a treatment option for their disease.
  • KYPROLIS is approved in the U.S. for the following:
    as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
  • KYPROLIS is indicated as a single agent for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy.
  • Acute renal failure was reported more frequently in patients with advanced relapsed and refractory multiple myeloma who received KYPROLIS monotherapy.

Global Kinase Inhibitors Market Report 2021: Data from 2019, 2020 Estimates for 2021 and Projections of CAGRs Through 2026 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 1, 2021
Biotechnology, Pharmaceutical, Health, Protein kinase inhibitors, Lactams, Tyrosine kinase inhibitors, Drugs, Morpholines, Enzyme inhibitors

The global market for kinase inhibitors should grow from $57.6 billion in 2021 to $79.2 billion by 2026 with a compound annual growth rate (CAGR) of 6.6% for the period of 2021-2026.

Key Points: 
  • The global market for kinase inhibitors should grow from $57.6 billion in 2021 to $79.2 billion by 2026 with a compound annual growth rate (CAGR) of 6.6% for the period of 2021-2026.
  • This report is designed to be a business tool that will provide a thorough evaluation of the markets for kinase inhibitors.
  • Various types of kinase inhibitors have been analyzed in the report, and along with their different application scenarios, the scope of this study includes regulatory aspects, pipeline analysis and demand for kinase inhibitors.
  • The market for kinase inhibitor market is experiencing an increasing demand for a number of novel kinase inhibitors being utilized in human trials.

Breckenridge Announces Approval of its ANDA for Carfilzomib Intravenous Powder (generic for Kyprolis®)

Retrieved on: 
Wednesday, June 16, 2021
Carfilzomib, Epoxides, Morpholines, Peptides, Natco, Onyx, Breckenridge

BERLIN, Conn., June 16, 2021 /PRNewswire/ --Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Carfilzomib Intravenous Powder (generic for Kyprolis).

Key Points: 
  • BERLIN, Conn., June 16, 2021 /PRNewswire/ --Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Carfilzomib Intravenous Powder (generic for Kyprolis).
  • Breckenridge received final approval for the 10mg and 60mg strengths and tentative approval for the 30mg strength.
  • Onyx Therapeutics, Inc., Breckenridge and Natco have reached a Settlement Agreement and the District Court case against Breckenridge and Natco has been dismissed.
  • According to industry sales data, Kyprolisgenerated annual sales of $711 million during the twelve months ending April 2021.

RespireRx Pharmaceuticals Inc. to Present in June 2021 Access China Biotech Virtual Investor Conference

Retrieved on: 
Tuesday, June 8, 2021
AMPA receptor positive allosteric modulators, Ampakines, Stimulants, Drugs, CX717, Enones, Morpholines, RespireRx, Ampakine, Pharmaceutical industry in India, Anticonvulsant, OTC Markets Group

Glen Rock, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. (OTCQB Market: RSPI) (RespireRx or the Company), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that the Companys senior management will participate in the following virtual investor conference in June 2021:

Key Points: 
  • Glen Rock, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- RespireRx Pharmaceuticals Inc. (OTCQB Market: RSPI) (RespireRx or the Company), a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that the Companys senior management will participate in the following virtual investor conference in June 2021:
    Access China Biotech 2021 Digital (June 9-14, 2021)
    The Access China Biotech Forumis a quarterly corporate access event series between China and Western biopharma.
  • We believe that the medical and patient community are in clear agreement that there is desperate need for improved antiepileptic drugs.
  • From our AMPAkine platform, our lead clinical compounds, CX717 and CX1739, have successfully completed multiple Phase 1 safety trials.
  • At present, the major pharmacotherapies available for ADHD are made up of two types of drugs.

Kronos Bio Announces Participation in Upcoming Investor Conferences

Retrieved on: 
Wednesday, May 26, 2021
Enzymes, Tyrosine kinase inhibitors, Chemical compounds, Entospletinib, Indazoles, Morpholines, Tyrosine kinase receptors, Tyrosine kinases, Branches of biology, CD135, Tyrosine-protein kinase SYK, Acute myeloid leukemia

The fireside chats will be webcast live from the Investors & Media section of the companys website at www.kronosbio.com .

Key Points: 
  • The fireside chats will be webcast live from the Investors & Media section of the companys website at www.kronosbio.com .
  • Kronos Bio is a clinical-stage biopharmaceutical company dedicated to discovering and developing therapies that seek to transform the lives of those affected by cancer.
  • Kronos Bio is developing a portfolio of spleen tyrosine kinase (SYK) inhibitors, entospletinib (ENTO) and lanraplenib (LANRA), for the treatment of NPM1-mutated and FLT3-mutated acute myeloid leukemia (AML).
  • Kronos Bio is based in San Mateo, Calif., and has a research facility in Cambridge, Mass.

Almirall receives positive CHMP opinion for Klisyri®▼ (tirbanibulin), an innovative topical treatment for actinic keratosis

Retrieved on: 
Friday, May 21, 2021
Pharmaceuticals policy, Health care, Health, Morpholines, Pyridines, Tirbanibulin, Actinic keratosis, Swissmedic, Marketing authorisation, Keratosis, Scalp, Almirall

In the KX01-AK-003 study, complete clearance was observed in 44% of the patients treated with tirbanibulin versus 5% for vehicle-treated groups.

Key Points: 
  • In the KX01-AK-003 study, complete clearance was observed in 44% of the patients treated with tirbanibulin versus 5% for vehicle-treated groups.
  • The approval of Klisyri (tirbanibulin) is expected in approximately 60 days and its launch in Europe could take place in late 2021.
  • Concerning other territories, Almirall submitted for a marketing authorisation in Switzerland in Q4 2020 and the dossier is currently under review by Swissmedic.
  • The company will also submit in Great Britain via the European Commission Decision Reliance Procedure.\nKlisyri (tirbanibulin) is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp.

Aumolertinib Significantly Prolongs Progression-Free Survival with Fewer Side Effects in the First-Line Treatment of Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, May 19, 2021
Oncology, Health, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Quinazolines, Amines, Chloroarenes, Gefitinib, Morpholines

Results of AENEAS suggest aumolertinib may possess truly differentiated benefits for patients in terms of efficacy and tolerability,\xe2\x80\x9d commented Vincent Miller, M.D., physician-in-chief of EQRx.

Key Points: 
  • Results of AENEAS suggest aumolertinib may possess truly differentiated benefits for patients in terms of efficacy and tolerability,\xe2\x80\x9d commented Vincent Miller, M.D., physician-in-chief of EQRx.
  • The median PFS was estimated at 19.3 months for aumolertinib and 9.9 months for gefitinib with a hazard ratio 0.46 (p
  • Improvement in PFS in patients who received aumolertinib over gefitinib was observed across relevant subgroups of patients, including those with brain metastases.
  • Adverse events that caused patients to temporarily stop or discontinue treatment altogether were less common with aumolertinib than with gefitinib.

Kronos Bio Reports Recent Business Progress and First Quarter Financial Results and Announces Virtual R&D Day

Retrieved on: 
Tuesday, May 11, 2021
Branches of biology, Entospletinib, Indazoles, Morpholines, Tyrosine-protein kinase SYK, Acute myeloid leukemia, NPM1, Myc, Tyrosine kinase

\xe2\x80\x9cWe recently showcased progress with our CDK9 program at the AACR annual meeting in April, where we presented preclinical data indicating that KB-0742 could have utility in the treatment of MYC-amplified cancers.

Key Points: 
  • \xe2\x80\x9cWe recently showcased progress with our CDK9 program at the AACR annual meeting in April, where we presented preclinical data indicating that KB-0742 could have utility in the treatment of MYC-amplified cancers.
  • We look forward to sharing more about our development plans for this compound at our research and development day.\xe2\x80\x9d\nDr.
  • The company focuses on targeting dysregulated transcription factors and the regulatory networks within cells that drive cancerous growth.
  • Kronos Bio\xe2\x80\x99s lead investigational therapy is entospletinib, a selective inhibitor targeting spleen tyrosine kinase (SYK) in development for the frontline treatment of NPM1-mutated acute myeloid leukemia (AML).