Tablet

Esperion Announces Data from CLEAR Outcomes Sub-Groups as Poster Presentations, Moderated Session & Industry Expert Theatre to be Presented at ACC.24

Retrieved on: 
Monday, March 25, 2024
Health, Tablet, CVD, Bempedoic acid, Risk, Patient, CLEAR, Esperies, Ezetimibe, Safety, ATP, Pharmaceutical industry

At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.

Key Points: 
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • Providers are moving toward reducing LDL-cholesterol levels as low as possible, as soon as possible; we provide the next steps to help get patients there.
  • Because when it comes to high cholesterol, getting to goal is not optional.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Verizon Business unveils AI-Powered ‘Experiences Room’ at Enterprise Connect

Retrieved on: 
Monday, March 25, 2024
Cloud, Microsoft, Verizon Communications, FWA, Verizon Business, Tablet, RSS, Communication, Small business, Wireless, Exhibition, Microsoft Teams, VZ, Government, Mobile phone

“Businesses have access to more communications, collaboration and cloud tools and solutions than ever before, but putting it all together can be daunting,” said Alex Doyle, VP of Product, Verizon Business.

Key Points: 
  • “Businesses have access to more communications, collaboration and cloud tools and solutions than ever before, but putting it all together can be daunting,” said Alex Doyle, VP of Product, Verizon Business.
  • “The goal of our Experiences Room and the demonstrations at our booth is to illustrate how Verizon Business’ forward-looking solutions can be applied in real-world scenarios today, whether you’re a small business, a global enterprise, or a government agency.”
    With a focus on customer-centric connected experiences, Verizon Business is showcasing innovative solutions including Fixed Wireless Access (FWA), managed tablets, Verizon Business Assistant, and more in its all new 5G and AI-powered Experiences Room located inside its conference booth (booth #619).
  • Cloud-Connected Calling and Communications: Power the modern workplace with the best fit collaboration platforms to drive business success, including the Webex Suite, Genesys Cloud and Virtual Contact Center, Verizon VoIP for Operator Connect, and Verizon Calling with Microsoft Teams.
  • Headquartered in New York City and with a presence around the world, Verizon generated revenues of $134.0 billion in 2023.

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024
Urinary tract infection, Anaphylaxis, Bronchitis, European Commission, Tendon rupture, Patient, European Medicines Agency, Bempedoic acid, Ezetimibe, Therapy, Citrate synthase, Anemia, Pain, Sinusitis, Abdominal pain, Risk, Gout, Ageing, Committee, ACL, Spasm, EMA, Back pain, ATP, Safety, Fatigue, CHMP, Arthralgia, Angioedema, Tablet, Constipation, Agent handling, Death, Pregnancy, CLEAR, Rash, Kidney, Moyamoya disease, Rupture, Apolipoprotein, Hypercholesterolemia, Hypersensitivity, Health, CVD, Incidence, Diarrhea, Fetus, Esperion Therapeutics, Diet, Upper respiratory tract infection, FDC, Uric acid

ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

First patient in the UK is dosed in the OATD-01 Phase 2 KITE study in pulmonary sarcoidosis

Retrieved on: 
Friday, March 22, 2024
PET/CT, Contract research organization, Biotechnology, Sarcoidosis, Disease, Patient safety, Patient, Tablet, Spirometry, Messenger, Quality of life, Biology, Royal, Fibrosis, Clinical trial, European, Arrest, Safety, Pharmacokinetics, MOC, Phase, KITE, FDA, FVC, ECG, Granuloma, Pharmaceutical industry

The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.

Key Points: 
  • The world's first administration of the chitotriosidase 1 (CHIT1) inhibitor (or placebo) to patient took place at the Royal Infirmary in Edinburgh.
  • As part of the trial, patients will take a daily fixed dose of 25 mg OATD-01 or placebo tablets for 12 weeks.
  • Patient safety will be monitored regularly through laboratory tests, neurological examinations and ECG and spirometry.
  • The study will involve approximately 20-30 centres in the US, the European Union, Norway and the UK.

Tonix Pharmaceuticals Announces Selection of Two Contract Manufacturing Organizations for the Launch and Commercial Manufacture of Tonmya™ for the Management of Fibromyalgia

Retrieved on: 
Wednesday, March 20, 2024
Fibromyalgia, Partnership, Patient, Tablet, Hydrogen chloride, NDA, Tonix Pharmaceuticals, Fatigue, Food, CMOS, Pharmaceutical industry

CHATHAM, N.J., March 20, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced it has selected two contract manufacturing organizations (CMOs), one of which is Almac Pharma Services, a member of the privately owned Almac Group, as dual supply sources for the potential launch and commercialization of Tonmya™ (also known as TNX-102 SL, cyclobenzaprine HCl sublingual tablets) in the U.S.

Key Points: 
  • As previously announced, Tonix’s second positive Phase 3 study, RESILIENT, met its pre-specified primary endpoint, significantly reducing daily pain compared to placebo (p=0.00005) in participants with fibromyalgia.
  • Statistically significant and clinically meaningful results (p=0.001 or better) were also seen in all key secondary endpoints related to improving sleep quality, reducing fatigue, and improving overall fibromyalgia symptoms and function.
  • TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies, and no new safety signals were observed.
  • Tonix plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration in the second half of 2024 for Tonmya for the management of fibromyalgia.

Entera Bio Announces Robust Pharmacokinetic Data for First-in-Class Oral GLP-2 Peptide Tablet Treatment for Patients with Short Bowel Syndrome

Retrieved on: 
Wednesday, March 20, 2024
Zealand Pharma, Plasma, Rat, LC-MS/MS, Short bowel syndrome, Half-life, Inflammation, Patient, Tablet, Teduglutide, POC, OPKO Health, Injection, Entera, Pharmaceutical industry

The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.

Key Points: 
  • The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.
  • Currently, the only approved GLP-2 agonist, which is marketed under the name Gattex® (teduglutide), requires daily sub-cutaneous injections.
  • Entera and OPKO completed a proof of concept (PoC) single dose pharmacokinetic study in rodents as the first validation for oral administration of the GLP-2 treatment.
  • This data is consistent with previously reported PK data relating to OPKO’s GLP-2 peptide’s long acting profile, which had initially been developed as a weekly subcutaneous injection.

XORTX Highlights Achievements of 2023 and Preparation for Registration Clinical Trial

Retrieved on: 
Tuesday, March 19, 2024
Consultant, Nephrology, Provisional application, XRX, Partnership, Chemistry, Kidney disease, Tablet, Orphan, Bryant University, University, EMA, Polycystic kidney disease, Trial of the century, Oxipurinol, MBA, GMP, Diet, PKD, Treatment, Society, Therapy, Patent, Rensselaer Polytechnic Institute, FDA, Marketing, Diagnosis, American Society of Nephrology, Uric acid, Pharmaceutical industry

Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals.

Key Points: 
  • Dr. Allen Davidoff, CEO of XORTX, stated, “2023 marked a year of substantial clinical, technological and regulatory progress, establishing the foundation for the Company’s 2024 goals.
  • Each of these milestones permit the next step in the Company’s clinical development plan, being a “registration” clinical trial – XRX-OXY-201 in pursuit of accelerated approval and support of the Company’s lead program XRx-008 program for ADPKD.
  • Chemistry and Manufacturing, Clinical and Pre-Clinical Highlights – Produced drug substance for oxypurinol production and produced GMP drug substance; confirmed XORLO™ formulation, produced enhanced bioavailability and produced clinical supply of tablets for clinical trials.
  • August 29, 2023 – XORTX submitted an Orphan Drug Designation application to the EMA for the treatment of ADPKD.

Tonix Pharmaceuticals Announces Transition to Fully Integrated Biopharmaceutical Company Expected on April 1, 2024

Retrieved on: 
Tuesday, March 19, 2024
Quality control, Fibromyalgia, Tablet, Hydrogen chloride, Acquisition, Commercial, Tonix Pharmaceuticals, Therapy, Marketing, FDA, Sumatriptan, Food, Pharmaceutical industry

CHATHAM, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will achieve its goal of transitioning to a fully integrated pharmaceutical company on April 1, 2024. Since the acquisition of Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg on June 30, 2023, Tonix Pharmaceuticals has been putting in place the personnel, systems and contracts required to support a commercial organization. Both products are indicated for the treatment of acute migraine with or without aura in adults.

Key Points: 
  • Zembrace® SymTouch® and Tosymra® will be marketed by Tonix Medicines, Tonix’s wholly-owned commercial subsidiary
    Commercial capabilities prepare Tonix for the potential launch in 2025 of Tonmya™ for the management of fibromyalgia, assuming FDA approval
    CHATHAM, N.J., March 19, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that it will achieve its goal of transitioning to a fully integrated pharmaceutical company on April 1, 2024.
  • Since the acquisition of Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg on June 30, 2023, Tonix Pharmaceuticals has been putting in place the personnel, systems and contracts required to support a commercial organization.
  • Both products are indicated for the treatment of acute migraine with or without aura in adults.
  • “Tonix will become a fully integrated biopharmaceutical company with a mission of developing and marketing innovative, high-value therapeutics,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.

BioXcel Therapeutics Announces European Patent Office’s Grant of Patent for Method of Treating Agitation in Dementia Using Sublingual Dexmedetomidine

Retrieved on: 
Friday, March 15, 2024
The Orange Book, Agitation, Patent, Intelligence, Patient, Tablet, Heel, EPO, Orange Book, Therapy, European Patent Convention, Dexmedetomidine, FDA, Dementia, Pharmaceutical industry

The 486 patent covers the use of dexmedetomidine administered sublingually to treat agitation in individuals with dementia.

Key Points: 
  • The 486 patent covers the use of dexmedetomidine administered sublingually to treat agitation in individuals with dementia.
  • The patent encompasses a broad range of dosage forms, including films such as BXCL501 (sublingual dexmedetomidine), wafers, and tablets, at dexmedetomidine doses ranging from 3 mcg to 100 mcg.
  • 17/496,470 with claims pertaining to methods of treating agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form.
  • The patent, when issued, is expected to have an expiration date of July 17, 2040, subject to patent term adjustment, patent term extension, and terminal disclaimers.