De novo synthesis

Oligonucleotide Synthesis Market to Exceed 9.9 billion by 2035 Say, Roots Analysis

Retrieved on: 
Wednesday, January 10, 2024
Neurological disorder, Centre for Process Innovation, University of Manchester, Overalls, Oligonucleotide, Intrinsic termination, DNA, Nucleotide, API, DSM-IV codes, MicroRNA, University, Novartis, Small RNA, Genetic testing, De novo synthesis, COVID-19, EUR, Therapy, FDF, AstraZeneca, Fine chemical

LONDON, Jan. 10, 2024 /PRNewswire/ -- The global oligonucleotide synthesis market is anticipated to be worth USD 3.5 billion in 2023, and it is expected to reach 9.9 billion by 2035. It is estimated to grow at a compounded annual growth rate (CAGR) of 16.1% during the forecast period (2023-2035).

Key Points: 
  • The oligonucleotide synthesis market faces several challenges, including the complexity of synthesis procedures, purification difficulties, gaps in analytical expertise, cost intensiveness, and regulatory constraints.
  • The growth factors for the oligonucleotide synthesis market include the expanding applications of oligonucleotides in genetic testing, diagnostics, and therapeutics.
  • Recent Developments in Oligonucleotide Synthesis Market:
    Several recent developments have taken place in the field of oligonucleotide synthesis.
  • FDF operation will dominate the oligonucleotide synthesis market during the forecast period and is anticipated to capture 53% of the market share in 2023.

ENDRA Life Sciences Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
Radiology, Health, Clinical Trials, Medical Devices, Proton, Sale, Magnetic resonance imaging, Hepatology, NAFLD, NDRA, Research, De novo, Food, Endocrinology, International, Magnetic resonance, PIN, Agency, FDA, Non-alcoholic fatty liver disease, Marketing, Liver, De novo synthesis, ATM, NPV, Fatty liver disease, Medical imaging, Video game

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS®), today reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • Highlights from the third quarter of 2023 and recent weeks include:
    Shared positive TAEUS clinical data at the Steatotic Liver Disease Summit™ 2023 hosted by the European Association for the Study of the Liver.
  • TAEUS estimates of liver fat fraction were strongly correlated to MRI-PDFF scores with a Pearson correlation coefficient of r=0.87.
  • During the third quarter of 2023 and recent weeks, ENDRA was issued six additional patents, including two in the U.S., two in Europe and two in China.

ENDRA Life Sciences' TAEUS De Novo Submission Advances to Next Stage of Review with FDA

Retrieved on: 
Wednesday, August 30, 2023
Health Technology, Health, Other Health, Medical Devices, Fatty liver disease, De novo, Non-alcoholic fatty liver disease, NDRA, Patient, De novo synthesis, Estar, NAFLD, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA).

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of imaging technologies and Thermo Acoustic Enhanced UltraSound (TAEUS®), announces that the Company's De Novo request for the TAEUS liver system has advanced to substantive review with the U.S. Food and Drug Administration (FDA).
  • “We are very pleased that our FDA De Novo submission has advanced to the substantive review stage," stated ENDRA's Chairman and Chief Executive Officer Francois Michelon.
  • On August 14, 2023, ENDRA submitted a De Novo request to the FDA using the electronic Submission Template And Resource (eSTAR) system.
  • On August 29, 2023, FDA informed ENDRA that the Company's submission was entering the substantive review period.

LATEST EFSA Approval: Choline Acknowledged for the first time as Essential Nutrient for Normal Liver Function of the Foetus and Exclusively Breastfed Infants1

Retrieved on: 
Wednesday, August 30, 2023
Health, Consumer, Fitness & Nutrition, Baby, Maternity, General Health, Pharmaceutical, Biotechnology, Folate, Neural tube, Myopathy, Human, Pregnancy, Life, DHA, Prenatal care, Liver, Nutrient, Woman, HEALTH, Risk, De novo, Mother, EPA, De novo synthesis, Pulse, Fetus, EFSA, Lipid metabolism, Lactation, Cell division, Choline, Human body, P&G, Dietary supplement, EU

Choline is involved in the structure of cell membranes, cell signaling, neurotransmitter synthesis and contributes as phosphatidylcholine to a normal lipid metabolism and transport from the liver to extrahepatic tissues.

Key Points: 
  • Choline is involved in the structure of cell membranes, cell signaling, neurotransmitter synthesis and contributes as phosphatidylcholine to a normal lipid metabolism and transport from the liver to extrahepatic tissues.
  • Always on the Pulse of Science, Femibion® identified Choline as the next essential nutrient that could be crucial from the first moment of life in prenatal care.
  • That’s why today our Femibion portfolio contains Choline with Femibion® Phase 1 (early pregnancy), Femibion® Phase 2 (pregnancy) and Femibion® Phase 3 (breastfeeding).
  • Low maternal folate level is one of the risk factors in the development of neural tube defects in the developing foetus.

Processa Pharmaceuticals Provides Data Update Supporting a Potential Personalized Treatment Approach for Improved Cancer Care

Retrieved on: 
Thursday, August 17, 2023
Acral lentiginous melanoma, Capecitabine, Pharming, Cancer, DPD, Gastrointestinal cancer, PCSA, Plasma, NGC, De novo synthesis, Metabolism, Patient, Physician, Patient safety, Colorectal cancer, Safety, Pharmaceutical industry, Vaccine, MD

HANOVER, MD, Aug. 17, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for patients suffering from cancer, provides an interim analysis from its ongoing Phase 1B trial of Next Generation Capecitabine (NGC-Cap) in patients with gastrointestinal cancer, which identifies a personalized treatment approach that may yield improved safety and treatment efficacy. NGC-Cap combines the administration of PCS6422, Processa’s irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of the commonly used chemotherapy capecitabine, which is metabolized to 5-fluorouracil (5-FU) in the body. DPD promotes the further metabolism of 5-FU to fluor-beta-alanine (FBAL), a metabolite that leads to dose-limiting chemotherapy side effects.

Key Points: 
  • DPD promotes the further metabolism of 5-FU to fluor-beta-alanine (FBAL), a metabolite that leads to dose-limiting chemotherapy side effects.
  • Processa has found that regularly measuring the concentrations of DPD, as expressed by the metabolite FBAL, may provide a method to better understand how each patient responds to different NGC-Cap dosage regimens.
  • Currently, capecitabine, among the most widely used chemotherapy drugs, is dosed based on a standard dosage regimen for all patients.
  • Unfortunately, many patients cannot tolerate that dose and must either have their dose reduced or have their treatment interrupted.

OrsoBio Acquires ACMSD Inhibitor Program to Address Mitochondrial Dysfunction from Mitobridge, an Astellas Company

Retrieved on: 
Wednesday, November 2, 2022
Health, Diabetes, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Pharmacology, Oxidative stress, Liver, MD, Steatosis, Lipotoxicity, Acquisition, Hepatocyte, Mouse, Doctor of Philosophy, Degenerative disease, Complementarity, Program, IPSC, Respiration (physiology), Chemistry, Institute of Liver and Biliary Sciences, Maintenance, Fatty liver disease, Rail profile, Foundation, Abstract, De novo synthesis, NAD, Patient, Poster, Biology, De novo, Gilead Sciences, Tryptophan, Dyslipidemia, Lipodystrophy, Pharmaceutical industry

OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced its acquisition of an ACMSD inhibitor program from Mitobridge, an Astellas Company.

Key Points: 
  • OrsoBio, Inc., a clinical-stage biopharmaceutical company developing treatments for severe metabolic disorders, today announced its acquisition of an ACMSD inhibitor program from Mitobridge, an Astellas Company.
  • The program includes a range of proprietary compounds being evaluated for their potential to address mitochondrial dysfunction in metabolic and inflammatory liver and kidney disorders.
  • ACMSD is highly expressed in the liver and kidneys and NAD+ is reduced in patients with advanced hepatic and renal disease.
  • TLC-065 and other compounds within the ACMSD inhibitor portfolio are being studied for their potential to replenish NAD+ and improve mitochondrial function.

ENDRA Life Sciences Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

Retrieved on: 
Wednesday, March 30, 2022
Medical Devices, Health, Hospitals, Surgery, Research, Science, Liver, Research, Risk, PIN, Technology, Securities Exchange Act of 1934, Securities Act of 1933, International, Time, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Result, Quality management system, Annual report, Fatty liver disease, Security (finance), Non-alcoholic fatty liver disease, Marketing, Trial of the century, Analysis, NASH, Industry, NDRA, U.S. Securities and Exchange Commission, Temperature, NASDAQ, Forward-looking statement, Health, De novo, Drug Quality and Security Act, Awareness, FDA, Patient, IP, Partnership, Classification, De novo synthesis, VGI, Financial condition report, Shanghai Jiao Tong University, Food, COVID-19, NAFLD, News, MRI, Pharmaceutical industry, 3D printing, Risk management

ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS), today reported financial results for the three months and year ended December 31, 2021 and provided a business update.

Key Points: 
  • ENDRA Life Sciences Inc. (NASDAQ: NDRA), a pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS), today reported financial results for the three months and year ended December 31, 2021 and provided a business update.
  • Highlights of the fourth quarter of 2021 and recent weeks include:
    Achieved clarity on the U.S. regulatory strategy for the TAEUS system.
  • ENDRA was also issued two European patents and two Chinese patents that broaden and expand its global IP portfolio.
  • Operating expenses increased to $3.1 million in the fourth quarter of 2021 from $2.3 million in the same period in 2020.

Median Technologies Files FDA 513(g) Regulatory Submission for iBiopsy® Lung Cancer Screening CADe/CADx Software as Medical Device

Retrieved on: 
Thursday, March 3, 2022
Biotechnology, FDA, Other Health, Health, Pharmaceutical, Oncology, Other Science, Medical Devices, Research, Science, Clinical Trials, Diagnosis, Medical device, BPI, Adoption, Patient, HCC, Liver cancer, De novo synthesis, LCS, Cirrhosis, Cade, Lists of diseases, Prognosis, Cave rescue, FDA, Solution, Precision medicine, Artificial intelligence, Calendar, Cancer, Technology, SME, Lung cancer screening, NASH, CEO, Data science, De novo, AI, Lung cancer, Classification, Software, DS, Medical imaging

Median Technologies (ALMDT) announces today that the company has filed a 513(g) submission on Feb. 17, 2022 to the United States Food and Drug Administration (FDA) for its iBiopsy Lung Cancer Screening (LCS) AI/ML technology-based end-to-end CADe/CADx1 Software as Medical Device (SaMD).

Key Points: 
  • Median Technologies (ALMDT) announces today that the company has filed a 513(g) submission on Feb. 17, 2022 to the United States Food and Drug Administration (FDA) for its iBiopsy Lung Cancer Screening (LCS) AI/ML technology-based end-to-end CADe/CADx1 Software as Medical Device (SaMD).
  • The 513(g) submission will allow Median Technologies to determine the best product classification and choose between the De Novo or the 510(k) regulatory pathways for iBiopsy LCS CADe/CADx SaMD.
  • Lung cancer is the deadliest cancer, and being able to detect it very early is of critical importance for patients.
  • About Median Technologies: Median Technologies provides innovative imaging solutions and services to advance healthcare for everyone.

ENDRA Life Sciences Provides Update on U.S. Regulatory Strategy for its TAEUS® System

Retrieved on: 
Wednesday, February 9, 2022
Research, FDA, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, NASDAQ, Drug Quality and Security Act, News, Industry, Forward-looking statement, General Electric Company, U.S. Securities and Exchange Commission, Securities Act of 1933, Element, Temperature, Time, Company, Ultrasound, De novo synthesis, Non-alcoholic fatty liver disease, Sale, Union, NDRA, FDA, Technology, Patient, Safety, Review, Liver, Magnetic resonance imaging, Security (finance), Classification, CE, Securities Exchange Act of 1934, GE Healthcare, Health, De novo, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Hydro Ottawa, Food, MRI, NAFLD, COVID-19, Medical imaging, Medical device, Risk management

While ENDRA could continue to pursue its 510(k) application, ENDRA now believes that the potential resulting 510(k) market claims may understate the TAEUS System's clinical and commercial value.

Key Points: 
  • While ENDRA could continue to pursue its 510(k) application, ENDRA now believes that the potential resulting 510(k) market claims may understate the TAEUS System's clinical and commercial value.
  • This is expected to accelerate 510(k) submissions of future generations of TAEUS products while creating market-entry barriers for competitive products.
  • About ENDRA Life Sciences Inc.
    ENDRA Life Sciences is the pioneer of Thermo Acoustic Enhanced UltraSound (TAEUS), a ground-breaking technology being developed to visualize tissue like MRI, but at 1/50th the cost and at the point of patient care.
  • Beyond the liver, ENDRA is exploring several other clinical applications of TAEUS, including visualization of tissue temperature during energy-based surgical procedures.

Atea Pharmaceuticals Announces Publication of Data Supporting Bemnifosbuvir’s (AT-527) Novel Mechanism of Action Against SARS-CoV-2 in Nature Communications

Retrieved on: 
Wednesday, February 2, 2022
Private Securities Litigation Reform Act, Safety, Patient, RNA, Niran, SEC, Degenerative disease, Â, De novo synthesis, Coronavirus, Aix-Marseille University, CNRS, RSV, Severe acute respiratory syndrome coronavirus 2, Membrane protein, Dengue virus, Research, COVID-19, Atea, Fertility, Reproduction, Architecture, Nature Communications, GLOBE, Biochemistry, Respiratory syncytial virus, Virology, Virus, HCV, Biology, RNA polymerase II, Nasdaq, Pharmaceutical industry, Vaccine

Bemnifosbuvir targets SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene that is unlikely to change as the virus mutates and new variants emerge.

Key Points: 
  • Bemnifosbuvir targets SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene that is unlikely to change as the virus mutates and new variants emerge.
  • In addition, in vitro data confirm that bemnifosbuvir is active against all variants of concern or interest that have been tested.
  • The data published today provide us with further confidence that we can meet the evolving needs of patients with COVID-19.
  • Both pathways are inhibited by AT-9010, the triphosphate metabolite of bemnifosbuvir, thus supporting bemnifosbuvirs unique dual mechanism of action for the treatment of COVID-19.