Excipient

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sunday, April 7, 2024
Uric acid, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, Atherosclerosis, FAHA, Cleveland Clinic, Bempedoic acid, Ezetimibe, Therapy, Anemia, Pain, MACE, Sinusitis, ACC, FOMA, FNLA, FACC, Obesity, Cardiovascular disease, Esperion Therapeutics, Abdominal pain, Risk, Gout, Spasm, Woman, American College, Body mass index, ESPR, Back pain, Outcome, ATP, Safety, Fatigue, Arthralgia, ANN, Angioedema, Kidney, Journal, Constipation, University, Adverse event, Pregnancy, CLEAR, Rash, MPH, Rupture, FDA, Molina Healthcare, JACC, Hypersensitivity, Health, Circulatory system, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Dietary supplement

ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

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.

U.S. FDA Approves Broad New Labels for Esperion’s 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
FDA, Health, Other Health, Pharmaceutical, Cardiology, Biotechnology, Photograph, 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, Webcast, Committee, Spasm, Splenic infarction, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, U.S. FDA, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Rupture, Molina Healthcare, Hypersensitivity, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Multimedia, Uric acid, Dietary supplement

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.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Partnership agreement between Croda and AAHI to drive innovation in vaccine development

Retrieved on: 
Tuesday, March 19, 2024
Infectious Diseases, Biotechnology, Pharmaceutical, Health, Partnership, CGMP, Research, Infection, Excipient, Immune system, Access, Vaccine, International, Administration

Croda International Plc (Croda) and The Access to Advanced Health Institute (AAHI) are pleased to announce today the signing of a partnership agreement around innovation and development of adjuvant formulations, under which Croda and AAHI will leverage their combined expertise to make novel vaccine adjuvant formulations globally accessible, thereby advancing next generation, robust and durable vaccines.

Key Points: 
  • Croda International Plc (Croda) and The Access to Advanced Health Institute (AAHI) are pleased to announce today the signing of a partnership agreement around innovation and development of adjuvant formulations, under which Croda and AAHI will leverage their combined expertise to make novel vaccine adjuvant formulations globally accessible, thereby advancing next generation, robust and durable vaccines.
  • With deep adjuvant and vaccine formulation expertise and years of experience developing cost-effective, sustainable products and processes for making them, AAHI stands at the forefront of vaccine innovation.
  • The exclusive agreement between AAHI and Croda includes a collaborative effort in research and development, combining the unique expertise of both entities, to propel rapid development of innovative adjuvants and formulations, and to develop efficient manufacturing processes to enable production at scale, to meet vaccine industry and global needs.
  • Further, the agreement grants Croda certain rights to market, distribute and sell selected novel adjuvant formulations developed by AAHI, for research purposes and clinical development.

IFF Announces Sale of its Pharma Solutions Business to Roquette

Retrieved on: 
Tuesday, March 19, 2024
Pharmaceutical, Health, Specialty, Chemicals, Plastics, Food, Beverage, Cosmetics, Manufacturing, Retail, Slate, Growth, Science, Partnership, Patient, Research, Sale, Excipient, Creativity, Pharma, Fine chemical

IFF (NYSE: IFF) today announced that it has entered into a definitive agreement to sell its Pharma Solutions business unit to French leader of plant-based ingredients Roquette for an enterprise value of up to $2.85 billion, which represents an enterprise value to EBITDA multiple of approximately 13x.

Key Points: 
  • IFF (NYSE: IFF) today announced that it has entered into a definitive agreement to sell its Pharma Solutions business unit to French leader of plant-based ingredients Roquette for an enterprise value of up to $2.85 billion, which represents an enterprise value to EBITDA multiple of approximately 13x.
  • IFF’s Pharma Solutions business is a well-established developer and manufacturer of pharmaceutical excipients and includes its Global Specialty Solutions business supporting industrial and methyl cellulosic food applications.
  • The Pharma Solutions business being sold to Roquette is primarily made up of businesses within IFF’s existing Pharma Solutions division, with some adjustments to the perimeter of the transaction designed to align customers, businesses and the manufacturing footprint.
  • “We are pleased to reach an agreement with Roquette that will support Pharma Solutions’ next chapter of growth as a trusted partner for the pharmaceutical industry,” said IFF CEO Erik Fyrwald.

Sangamo Therapeutics Reports Recent Business Highlights and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, March 13, 2024
Health, Neurology, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, STAC, Gene, Orphan drug, ALTA, Haemophilia A, BBB, Patient, Health care, Quality of life, IND, Male, ERT, Investment, Therapy, Fabry disease, Plasma, Kite, Gene expression, Partnership, Central nervous system, Novartis, CNS, Pivotal, EMA, Prion, STAAR, Enzyme replacement therapy, Biogen, Tauopathy, Workforce, BLA, AAV, Sanofi, Research, DRG, Neuron, Hematology, FDA, DSM-IV codes, Brain, Sangamo Therapeutics, MAA, Haemophilia, CTA, Mouse, Female, Traffic barrier, Sodium, MHRA, Excipient, Society, Spinal cord, Toxicology, Sigma-Aldrich, Liver, Pharmaceutical industry

Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today reported recent business highlights and fourth quarter and full year 2023 financial results, including meaningful data to support advancement of its neurology pipeline.

Key Points: 
  • Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, today reported recent business highlights and fourth quarter and full year 2023 financial results, including meaningful data to support advancement of its neurology pipeline.
  • “In 2023, Sangamo announced the prioritization of its pipeline programs that support our focus as a neurology-focused genomic medicine company,” said Sandy Macrae, Chief Executive Officer of Sangamo.
  • STAC-BBB was well tolerated in NHPs, with no notable treatment related pathological findings in brain, spinal cord or peripheral tissues.
  • Revenues for the fourth quarter ended December 31, 2023 were $2.0 million, compared to $27.2 million for the same period in 2022.

Sangamo Therapeutics Announces Data From Novel Proprietary Neurotropic AAV Capsid Demonstrating Industry-leading Blood-brain Barrier Penetration and Brain Transduction in NHPs

Retrieved on: 
Wednesday, March 13, 2024
Research, Neurology, Genetics, Clinical Trials, Health, Pharmaceutical, General Health, Other Science, Science, STAC, AAV, Sangamo Therapeutics, Gene, Brain, Capsid, Gene expression, ALS, BBB, Central nervous system, Novartis, CNS, CTA, DRG, Traffic barrier, Prion, NHP, Tropism, IND, Nav1.7, Neuron, Biogen, Tauopathy, Excipient, Therapy, DSM-IV codes, Spinal cord, Liver, Animal, Vaccine

Sangamo is exploring avenues to resume development of these programs internally, subject to receipt of adequate funding, or with new potential collaborators.

Key Points: 
  • Sangamo is exploring avenues to resume development of these programs internally, subject to receipt of adequate funding, or with new potential collaborators.
  • In NHP studies when administered intravenously at clinically relevant doses, STAC-BBB demonstrated its potential to be a leading neurotropic capsid.
  • Exhibited 700-fold higher transgene expression in neurons compared to the benchmark capsid AAV9 and outperformed all other known published neurotropic capsid variants evaluated in the study.
  • STAC-BBB was well tolerated in NHPs, with no notable treatment related pathological findings in brain, spinal cord or peripheral tissues.

IFF Brings Science-Backed Excipients to Asia Pharmaceutical Industry at CPhI Japan 2024

Retrieved on: 
Tuesday, March 26, 2024
Hardness, All rights reserved, Health, SMCC, Application, Science, Risk, Tablet, Research, Tokyo Big Sight, Food, Excipient, Creativity, Sodium, ODT, Lubricant

TOKYO, March 25, 2024 /PRNewswire/ -- IFF, a global leader in food and beverage, home and personal care and health, will present its broad portfolio and latest excipient technology to CPhI Japan 2024 at booth 5K21, Tokyo Big Sight, Tokyo from April 17-19.IFF's Pharma Solutions offers high-quality pharmaceutical solutions backed by extensive research and expertise. The team will showcase its comprehensive cellulosic-derived excipients portfolio of innovative solutions, from binders and disintegrants to lubricants and matrix systems across the immediate release, controlled release, pediatric and novel delivery formulations.

Key Points: 
  • IFF's Pharma Solutions offers high-quality pharmaceutical solutions backed by extensive research and expertise.
  • "As a first-time participant at CPhI Japan, we are excited about the opportunity to connect with customers and industry peers," said Frank Zhao, commercial leader, Asia-Pacific, Pharma Solutions, IFF.
  • "This event provides us with a valuable opportunity to showcase our innovative offerings and demonstrate our commitment to driving advancements in pharmaceutical development."
  • IFF, the IFF Logo, and all trademarks and service marks denoted with ™, ℠ or ® are owned by IFF or affiliates of IFF unless otherwise noted.

Clinical Trial Supply & Logistics Market Projected to Reach $41.04 billion by 2030 - Exclusive Report by 360iResearch

Retrieved on: 
Monday, March 25, 2024
Catalent, Medical device, Temperature, Growth, Prevalence, Face, Molecule, Thermo Fisher Scientific, Medication, CTSL, Pharmacy, Partnership, Intelligence, Imp, Conditional sentence, ICON, Global health, Research, Good manufacturing practice, IMP, Transport, ICON PLC, Placebo, Infosys, GMP, Excipient, Investment, Clinical trial, GDP, Drug development, API, Clinical data management, Table, Ageing, Parexel

"Global Growth Trends in Clinical Trial Supply & Logistics: Navigating Challenges, Driving Innovation"

Key Points: 
  • "Global Growth Trends in Clinical Trial Supply & Logistics: Navigating Challenges, Driving Innovation"
    Clinical trial supply and logistics (CTSL) is a critical backbone for conducting clinical studies worldwide, providing essential services, including planning, storing, managing, and distributing clinical trial materials (CTMs).
  • South America also sees increased adoption of clinical trial supply and logistics, fueled by its developing healthcare infrastructure.
  • We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Clinical Trial Supply & Logistics Market.
  • "Dive into the Clinical Trial Supply & Logistics Market Landscape: Explore 187 Pages of Insights, 582 Tables, and 26 Figures"

Clinical Trial Supply & Logistics Market Projected to Reach $41.04 billion by 2030 - Exclusive Report by 360iResearch

Retrieved on: 
Monday, March 25, 2024
Catalent, Medical device, Temperature, Growth, Prevalence, Face, Molecule, Thermo Fisher Scientific, Medication, CTSL, Pharmacy, Partnership, Intelligence, Imp, Conditional sentence, ICON, Global health, Research, Good manufacturing practice, IMP, Transport, ICON PLC, Placebo, Infosys, GMP, Excipient, Investment, Clinical trial, GDP, Drug development, API, Clinical data management, Table, Ageing, Parexel

"Global Growth Trends in Clinical Trial Supply & Logistics: Navigating Challenges, Driving Innovation"

Key Points: 
  • "Global Growth Trends in Clinical Trial Supply & Logistics: Navigating Challenges, Driving Innovation"
    Clinical trial supply and logistics (CTSL) is a critical backbone for conducting clinical studies worldwide, providing essential services, including planning, storing, managing, and distributing clinical trial materials (CTMs).
  • South America also sees increased adoption of clinical trial supply and logistics, fueled by its developing healthcare infrastructure.
  • We proudly unveil ThinkMi, a cutting-edge AI product designed to transform how businesses interact with the Clinical Trial Supply & Logistics Market.
  • "Dive into the Clinical Trial Supply & Logistics Market Landscape: Explore 187 Pages of Insights, 582 Tables, and 26 Figures"