Organic compounds

DGAP-News: PAION RECEIVES UK MHRA APPROVAL OF BYFAVO (REMIMAZOLAM) FOR PROCEDURAL SEDATION

Retrieved on: 
Tuesday, June 29, 2021
Anesthesia, Chemical compounds, Organic compounds, GABAA receptor positive allosteric modulators, Pyridines, Remimazolam, Sedation, MHRA, Intensive care unit, Procedural sedation and analgesia, remimazolam, PAION, REMIMAZOLAM, PAION

Aachen (Germany), 29 June 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo(R) (remimazolam besylate) in adults for procedural sedation.

Key Points: 
  • Aachen (Germany), 29 June 2021 - The specialty pharma company PAION AG (PA8; ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard) today announces that the UK Medicines & Healthcare products Regulatory Agency (MHRA) has approved Byfavo(R) (remimazolam besylate) in adults for procedural sedation.
  • The decision follows the approval of the European Commission in the EU (including European Economic Area (EEA) countries) in March 2021.
  • Dr. Jim Phillips, CEO of PAION AG, commented: "We are excited that the MHRA has approved Byfavo(R).
  • In addition to procedural sedation and general anesthesia, intensive care unit (ICU) sedation is another possible indication for remimazolam.

Addex Therapeutics Initiates Pivotal Phase 2b/3 Study with Dipraglurant for Dyskinesia Associated with Parkinson’s Disease

Retrieved on: 
Tuesday, June 29, 2021
Neurological disorders, Organic compounds, Parkinson's disease, Branches of biology, Dipraglurant, Imidazopyridines, Organofluorides, Levodopa-induced dyskinesia, Catecholamines, Dyskinesia, L-DOPA

We also expect to start an exploratory Phase 2 study with dipraglurant in blepharospasm patients in the coming months.

Key Points: 
  • We also expect to start an exploratory Phase 2 study with dipraglurant in blepharospasm patients in the coming months.
  • In a Phase 2a study dipraglurant met its primary endpoint by being generally well tolerated and showing no clinically significant safety issues.
  • However, the development of dyskinesia which may be associated with long-term use of levodopa can become as disabling as the symptoms of Parkinson's disease.
  • Addexs lead product candidate, dipraglurant (mGlu5 negative allosteric modulator or NAM) is in a pivotal registration clinical trial for Parkinsons disease levodopa induced dyskinesia (PD-LID).

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options

Retrieved on: 
Monday, June 28, 2021
Research, LGBTQ+, Pharmaceutical, Consumer, Infectious diseases, Hospitals, Clinical trials, Science, Biotechnology, AIDS, FDA, Health, Chemical compounds, Organic compounds, Chemistry, Specialty drugs, Cyclopropanes, Gilead Sciences, Sulfonamides, Lenacapavir

Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.

Key Points: 
  • Gilead plans to submit marketing authorization applications for lenacapavir to the European Medicines Agency and other global agencies in the coming months.
  • Lenacapavir is a potential first-in-class, long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection.
  • GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.
  • For more information about Gilead, please visit the companys website at www.gilead.com , follow Gilead on Twitter ( @Gilead Sciences ) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Global Polybutylene Terephthalate (PBT) Market 2021: How Major End-Use Industries for PBT are Impacted by the Pandemic & the New Normal - ResearchAndMarkets.com

Retrieved on: 
Monday, June 28, 2021
Chemicals, Plastics, Manufacturing, Organic polymers, Plastics, Organic compounds, Chemistry, Polyesters, Thermoplastics, Commodity chemicals, Polybutylene terephthalate, PBT, Polybutylene, Polyethylene terephthalate, Terephthalic acid

The "Polybutylene Terephthalate (PBT) - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Polybutylene Terephthalate (PBT) - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering.
  • Automotive, one of the segments analyzed in the report, is projected to grow at a 5.1% CAGR to reach 648.1 Thousand Metric Tons by the end of the analysis period.
  • This segment currently accounts for a 35.5% share of the global Polybutylene Terephthalate (PBT) market.
  • The Polybutylene Terephthalate (PBT) market in the U.S. is estimated at 134.1 Thousand Metric Tons in the year 2020.

Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer

Retrieved on: 
Monday, June 28, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Chemical compounds, Orphan drugs, Drugs, Organic compounds, Antineoplastic drugs, Tyrosine kinase inhibitors, Cabozantinib, Cyclopropanes, Quinolines, Exelixis, Ipsen, Sorafenib, COSMIC-312, HCC, CABOMETYX® (cabozantinib), Ipsen, COSMIC-312, HCC, CABOMETYX® (CABOZANTINIB), IPSEN

Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).

Key Points: 
  • Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).
  • In the European Union, CABOMETYX is also approved in combination with nivolumab as first line treatment for patients living with advanced RCC.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Exelixis and Ipsen Announce Cabozantinib in Combination with an Immune Checkpoint Inhibitor Significantly Improved Progression-Free Survival in Phase 3 COSMIC-312 Pivotal Trial in Patients with Previously Untreated Advanced Liver Cancer

Retrieved on: 
Monday, June 28, 2021
Research, FDA, Clinical trials, Other Health, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Chemical compounds, Orphan drugs, Drugs, Organic compounds, Antineoplastic drugs, Tyrosine kinase inhibitors, Cabozantinib, Cyclopropanes, Quinolines, Exelixis, Ipsen, Sorafenib, COSMIC-312, HCC, CABOMETYX® (cabozantinib), Ipsen, COSMIC-312, HCC, CABOMETYX® (CABOZANTINIB), IPSEN

Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).

Key Points: 
  • Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg).
  • In the European Union, CABOMETYX is also approved in combination with nivolumab as first line treatment for patients living with advanced RCC.
  • In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan.
  • The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies.

Upsher-Smith Launches Isotretinoin Capsules

Retrieved on: 
Friday, June 25, 2021
Anti-acne preparations, Chemical compounds, Retinoids, Organic compounds, Clinical medicine, Enones, Isotretinoin, Polyenes, iPLEDGE program, Pregnancy, Tretinoin, Acne

Isotretinoin capsules can cause lifethreatening birth defects and is contraindicated in pregnancy.

Key Points: 
  • Isotretinoin capsules can cause lifethreatening birth defects and is contraindicated in pregnancy.
  • There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time.
  • Isotretinoin capsules are available only through a restricted program called the iPLEDGE REMS.
  • Please refer to the full Prescribing Information, including Boxed Warning for Isotretinoin Capsules here .

Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

Retrieved on: 
Friday, June 25, 2021
Chemical compounds, Acetic acids, Organic compounds, Isoquinolines, Roxadustat, Kidney diseases, Chronic kidney disease, Chronic condition, Anemia, HIF prolyl-hydroxylase inhibitor, Molidustat

The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).

Key Points: 
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).
  • Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data.
  • Anemia and iron deficiency among chronic kidney disease Stages 3-5ND patients in the Chronic Kidney Disease Outcomes and Practice Patterns Study: often unmeasured, variably treated.
  • Anemia in Chronic Kidney Disease: National Institute of Diabetes and Digestive and Kidney Disease.

Research showed that InxMed FAK Inhibitor (IN10018) Overcomes Drug Resistance of KRAS G12C inhibitors and Synergizes with KRAS G12C inhibitors in Treating Cancer

Retrieved on: 
Friday, June 25, 2021
Chemical compounds, Piperazines, KRAS, Organic compounds, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Sotorasib, Targeted covalent inhibitors, Adagrasib

It can simultaneously reduce the extent of drug resistance to improve treatment outcomes of KRAS G12C inhibitors.

Key Points: 
  • It can simultaneously reduce the extent of drug resistance to improve treatment outcomes of KRAS G12C inhibitors.
  • Diverse CDX and PDX models of KRAS G12C mutant cancers were tested and synergistic benefits from the combination therapy of KRAS G12C inhibitors (AMG510 or MRTX849) and FAK inhibitor (IN10018) were consistently observed.
  • Mechanistically, it is found that aberrant FAKYAP signaling leading to the development of KRAS G12C inhibitor resistance.
  • Dr. Zaiqi Wang, InxMed's Chairman and CEO, said "This study showed that FAK inhibitor (IN10018) overcomes drug resistance of KRAS G12C inhibitors and provides a potential innovative combination therapy to improve treatment outcomes for KRAS G12C mutant cancers.

Lyndra Therapeutics Completes $60.5 Million Series C Financing

Retrieved on: 
Thursday, June 24, 2021
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Other Health, Chemical compounds, Organic compounds, Drugs, Prolactin releasers, Atypical antipsychotics, Lactams, Mood stabilizers, Piperidines, Risperidone, Schizophrenia

Lyndra Therapeutics , a clinical-stage biotechnology company pioneering a novel technology platform that transforms daily pills into once-weekly to monthly oral treatment options, today announced the closing of its $60.5 million Series C financing.

Key Points: 
  • Lyndra Therapeutics , a clinical-stage biotechnology company pioneering a novel technology platform that transforms daily pills into once-weekly to monthly oral treatment options, today announced the closing of its $60.5 million Series C financing.
  • View the full release here: https://www.businesswire.com/news/home/20210624005094/en/
    Lyndras ultra-long-acting, extended-release oral capsule dosage form technology is the first of its kind.
  • Our trailblazing lead product candidate is a once-weekly oral risperidone treatment which has the potential to provide a meaningful benefit to the over two million people with schizophrenia, their caregivers and healthcare providers, said Dr. Patricia Hurter, Chief Executive Officer of Lyndra Therapeutics.
  • Lyndra has raised almost $250 million in funding, inclusive of this round.