Center for Drug Evaluation and Research

Global Single-use Filtration Assemblies Market Report 2023: Sector is Expected to Reach $11.8 Billion by 2030 at a CAGR of 18.7% - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 15, 2023
Biotechnology, Pharmaceutical, Health, Drug development, Therapy, Prevalence, TFF, Center for Drug Evaluation and Research, COVID-19, DFF, Cancer, Cross-flow filtration, Research, Immunology, USD, Sterilization, Risk, Filtration, Conditional sentence, Growth, ONS, Cholinergic crisis, FDA, Neurology, Safety, Sewage treatment, Fine chemical, Pharmaceutical industry

The global single-use filtration assemblies market size is expected to reach USD 11.8 billion by 2030.

Key Points: 
  • The global single-use filtration assemblies market size is expected to reach USD 11.8 billion by 2030.
  • The market is expected to expand at a CAGR of 18.70% from 2023 to 2030.
  • Single-use filtration assemblies offer several advantages over traditional filtration systems, such as reduced contamination risk, lower capital costs, and increased flexibility.
  • Membrane filtration sub segmented into TFF and direct flow filtration (DFF) /dead-end filtration /normal flow filtration.

Nordic Bioscience's unique biomarker PRO-C3 gets green light for further study in cancer from US FDA in formal Letter of Support

Retrieved on: 
Thursday, June 15, 2023
Marketing, Center for Drug Evaluation and Research, Neoplasm, Cancer, Attention, Biomarker, Patient, Risk, Roche, Extracellular matrix, IVD, Conditional sentence, FDA, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tumor microenvironment, III, Food, Fibroblast, Medical imaging, Research

This letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor fibrosis studies.

Key Points: 
  • This letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor fibrosis studies.
  • The FDA's LoS demonstrates that Nordic Bioscience's PRO-C3 biomarker is uniquely positioned to support research and clinical trials in this area.
  • Morten A. Karsdal, Chief Executive Officer of Nordic Bioscience commented: "This is the world's first blood-based tumor fibrosis biomarker for patients with aggressive solid tumors.
  • We strongly believe in the value and performance of our PRO-C3 biomarker and are proud to receive the LoS from the FDA.

Nordic Bioscience's unique biomarker PRO-C3 gets green light for further study in cancer from US FDA in formal Letter of Support

Retrieved on: 
Thursday, June 15, 2023
Marketing, Center for Drug Evaluation and Research, Neoplasm, Cancer, Attention, Biomarker, Patient, Risk, Roche, Extracellular matrix, IVD, Conditional sentence, FDA, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Tumor microenvironment, III, Food, Fibroblast, Medical imaging, Research

This letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor fibrosis studies.

Key Points: 
  • This letter acknowledges and supports further study of the PRO-C3 biomarker assay as a prognostic biomarker in tumor fibrosis studies.
  • The FDA's LoS demonstrates that Nordic Bioscience's PRO-C3 biomarker is uniquely positioned to support research and clinical trials in this area.
  • Morten A. Karsdal, Chief Executive Officer of Nordic Bioscience commented: "This is the world's first blood-based tumor fibrosis biomarker for patients with aggressive solid tumors.
  • We strongly believe in the value and performance of our PRO-C3 biomarker and are proud to receive the LoS from the FDA.

Ascentage Pharma's Novel Drug Olverembatinib Recommended for a Breakthrough Therapy Designation in China for the Treatment of SDH-Deficient GIST, the Second BTD for the Drug

Retrieved on: 
Wednesday, May 31, 2023
TKI, GIST, E pluribus unum, Priority review, Science, Malignancy, Drug development, Gastrointestinal tract, CML, New Drug Application, American Society of Clinical Oncology, Succinate dehydrogenase, NDA, Cancer, Quality of life, SDH, Mutation, CHB, BTD, BCR-ABL, Prognosis, Research, John-Ross Rizzo, Multimedia, CBR, Bangladesh Technical Education Board, ASCO, KIT, Patient, PDGFRA, Douglas BTD Destroyer, Annual general meeting, National Medical Products Administration, CDE, EFS, Center for Drug Evaluation and Research, Notifiable disease, Gastrointestinal stromal tumor, Society, NMPA, Hepatitis, Pharmaceutical industry, Silviculture

To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.

Key Points: 
  • To date, olverembatinib has been granted two Priority Review Designations that underscored the drug's promising therapeutic utility.
  • Drugs that have been granted BTDs are prioritized by the CDE in communications and exchange, and in receiving guidance to advance the drug development progress.
  • Furthermore, BTD-designated drugs will be eligible for Priority Review status and conditional approvals upon submission of a New Drug Application (NDA).
  • Antitumor activity of olverembatinib (HQP1351) in patients (pts) with tyrosine kinase inhibitor (TKI)–resistant succinate dehydrogenase (SDH)–deficient gastrointestinal stromal tumor (GIST).

MindMed Publishes Report by Leading FDA Experts Validating MindMed’s MM-120 Drug Development Strategy

Retrieved on: 
Thursday, May 25, 2023
Other Health, Research, General Health, Professional Services, Pharmaceutical, Mental Health, Science, Biotechnology, FDA, Consulting, Other Science, Health, GAD, NOT, Center for Drug Evaluation and Research, Medicine, Anxiety, LSD, Patient, Investment, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, NEO, Food, MindMed, FCM, Pharmaceutical industry, Medical device, Security (finance)

The findings support MindMed’s view that this trial is essential to the development of MM-120 in GAD and answers critical questions to inform a responsible development program.

Key Points: 
  • The findings support MindMed’s view that this trial is essential to the development of MM-120 in GAD and answers critical questions to inform a responsible development program.
  • “As we have consistently said, our regulatory strategy for MM-120 is the right one and was formulated over several interactions with FDA.
  • Shareholders will receive proxy materials directly via the preferred method, hard copy or email, specific to each shareholder’s account.
  • If you have any questions, or need assistance voting your shares, please contact the firm assisting us in the solicitation of proxies:

FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults

Retrieved on: 
Thursday, May 25, 2023
EUA, Taste, Post-exposure prophylaxis, Vaccine, Shenzhen Kangtai Biological Products, Office of Inspector General, U.S. Department of Health and Human Services, Diarrhea, Hospital, Center for Drug Evaluation and Research, Human services, Public, COVID-19, Clinical trial, Immunity, Food, Cosmetics, Multimedia, RNA, Animal, Federal Food, Drug, and Cosmetic Act, Dietary supplement, Patient, Risk, Diagnosis, Heated tobacco product, Research, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, Disease, Pharmaceutical industry, SARS-CoV-2, Nirmatrelvir/ritonavir

Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.

Key Points: 
  • Paxlovid is the fourth drug—and first oral antiviral pill—approved by the FDA to treat COVID-19 in adults.
  • The FDA remains committed to working with sponsors to facilitate the development of new prevention and treatment options for COVID-19."
  • EPIC-HR was a randomized, double-blind, placebo-controlled clinical trial studying Paxlovid for the treatment of non-hospitalized symptomatic adults with a laboratory confirmed diagnosis of SARS-CoV-2 infection.
  • Based on the data currently available to the FDA, there is not a clear association between Paxlovid treatment and COVID-19 rebound.

FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

Retrieved on: 
Tuesday, May 23, 2023
Hypersensitivity, Infection, Priority review, Center for Drug Evaluation and Research, Enzyme, Colistin, Imipenem/cilastatin, History, VABP, Patient, Division, Sulbactam, Bronchopneumonia, Bacteria, Mortality, Research, Health, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pneumonia, Food, World Health Organization, Vaccine, Pharmaceutical industry

"Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."

Key Points: 
  • "Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."
  • Acinetobacter baumannii-calcoaceticus complex (henceforth referred to as A. baumannii) includes four species of bacteria in the Acinetobacter family.
  • These bacteria can cause infections in various parts of the body, occurring most frequently in healthcare settings and predominantly causing pneumonia.
  • A. baumannii can become highly resistant to multiple antibacterial drugs and current treatment options for drug-resistant A. baumannii are limited.

Zai Lab Announces That Repotrectinib Granted Priority Review by China’s NMPA

Retrieved on: 
Thursday, May 18, 2023
Drug, Priority review, Interim, Partnership, Bureau, TKI, Medicine, NSCLC, HKEX, Patient, Approval, CDE, National Medical Products Administration, Center for Drug Evaluation and Research, NMPA, Pharmaceutical industry

SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).

Key Points: 
  • SHANGHAI, China and CAMBRIDGE, Mass., May 18, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
  • “The CDE’s decision to grant priority review to repotrectinib underscores repotrectinib as a potential next-generation best-in-class treatment for ROS1-positive NSCLC in both TKI-naïve and pretreated patients in China,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • It is implemented under the Drug Registration Regulation (Bureau Order 27) and the Working Procedure for Priority Review and Approval of Drug Marketing Authorization (Interim, NMPA 2020 No.
  • According to the regulation and guidance, the regulatory authority will prioritize the evaluation resources for applications under priority review to expedite the review and approval timelines.

Prothena Announces Appointment of Billy Dunn, M.D., to its Board of Directors

Retrieved on: 
Tuesday, May 16, 2023
Biotechnology, Pharmaceutical, Health, Other Health, CDER, Migraine, Drug development, University, Therapy, Center for Drug Evaluation and Research, Myasthenia gravis, DSM-IV codes, Multimedia, Multiple sclerosis, Patient, Division, Epilepsy, Neuro, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Research, Medicine

Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, announced today the appointment of Billy Dunn, M.D., to its Board of Directors.

Key Points: 
  • Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, announced today the appointment of Billy Dunn, M.D., to its Board of Directors.
  • View the full release here: https://www.businesswire.com/news/home/20230516005750/en/
    Dr. Billy Dunn joins the Prothena Board of Directors (Photo: Business Wire)
    “For nearly two decades, Dr. Dunn has dedicated his career as a public servant to bringing new and innovative products to patients suffering from neurodegenerative diseases through his leadership role at the FDA.
  • “We look forward to working closely with Dr. Dunn with a shared vision to make meaningful differences for patients.”
    “I am excited to join at this transformational time for Prothena.
  • Dr. Dunn is a trained neurologist and vascular neurologist with experience in basic research, clinical research, and clinical care.

FDA Approves Novel Drug to Treat Moderate to Severe Hot Flashes Caused by Menopause

Retrieved on: 
Friday, May 12, 2023
Vaginal bleeding, Infection, Kidney disease, Priority review, Liver, Food, Pediatrics, Diarrhea, Center for Drug Evaluation and Research, Chills, Menopause, Liver disease, Stroke, Skin, Quality of life, Woman, Liver injury, History, Abdominal pain, Hot, Hot flash, Hormone, CYP1A2, Vomiting, Thermoregulation, Insomnia, Back pain, Rare, Patient, Perspiration, Nausea, Progesterone, Research, Reproductive medicine, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cirrhosis, Flushing, Safety, Pharmaceutical industry, Birth control

SILVER SPRING, Md., May 12, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant) , an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.

Key Points: 
  • SILVER SPRING, Md., May 12, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Veozah (fezolinetant) , an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause.
  • Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause.
  • "The introduction of a new molecule to treat moderate to severe menopausal hot flashes will provide an additional safe and effective treatment option for women."
  • The effectiveness of Veozah to treat moderate to severe hot flashes was demonstrated in each of the first 12-week, randomized, placebo-controlled, double-blind portions of two phase 3 clinical trials.