Center for Drug Evaluation and Research

FDA Approves New Drug to Prevent RSV in Babies and Toddlers

Retrieved on: 
Monday, July 17, 2023
Vaccine, Infection, China Biologic Products, Bronchiolitis, Ventricular septal defect, Pediatrics, Office of Inspector General, U.S. Department of Health and Human Services, Hospital, Center for Drug Evaluation and Research, Gestational age, Human services, Public, Late preterm infant, Pediatrics (journal), American Academy, Food, Cosmetics, Multimedia, Coagulopathy, History, AstraZeneca, Animal, Ill, Rash, Respiratory syncytial virus, Incidence, Excipient, RSV, Dietary supplement, Premature, Immunoglobulin G, Risk, Anaphylaxis, MA, Heated tobacco product, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Virus, Pneumonia, Safety, Birth control, Pharmaceutical industry, Nirsevimab

"Today's approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system."

Key Points: 
  • "Today's approval addresses the great need for products to help reduce the impact of RSV disease on children, families and the health care system."
  • Premature infants, and those with chronic lung disease of prematurity or significant congenital heart disease, are at highest risk for severe RSV disease.
  • One dose of Beyfortus, administered as a single intramuscular injection prior to or during RSV season, may provide protection during the RSV season.
  • The safety and pharmacokinetic data from Trial 05 provided evidence for the use of Beyfortus to prevent MA RSV LRTI in this population.

FDA Approves First Nonprescription Daily Oral Contraceptive

Retrieved on: 
Thursday, July 13, 2023
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Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.

Key Points: 
  • Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, convenience stores and grocery stores, as well as online.
  • "Today's approval marks the first time a nonprescription daily oral contraceptive will be an available option for millions of people in the United States," said Patrizia Cavazzoni, M.D., director of the FDA's Center for Drug Evaluation and Research.
  • "When used as directed, daily oral contraception is safe and is expected to be more effective than currently available nonprescription contraceptive methods in preventing unintended pregnancy."
  • Opill also should not be used together with another hormonal birth control product such as another oral contraceptive tablet, a vaginal ring, a contraceptive patch, a contraceptive implant, a contraceptive injection or an IUD (intra-uterine device).

BPSA Releases Guide on X-Ray Sterilization of Single-Use Bioprocessing Equipment, Part 2: Representative Qualification Data

Retrieved on: 
Thursday, July 13, 2023
Bio Process Systems Alliance, BPSA, Requirement, Center for Drug Evaluation and Research, Medicines and Healthcare products Regulatory Agency, Research, Part, Doctor of Philosophy, Sterilization, Patient, FDA, News, Sartorius, Medical device, Medical imaging

To support the risk assessments needed for such implementation, BPSA has generated supporting data evaluating the performance levels of X-ray sterilization and gamma-ray sterilization on certain single-use materials.

Key Points: 
  • To support the risk assessments needed for such implementation, BPSA has generated supporting data evaluating the performance levels of X-ray sterilization and gamma-ray sterilization on certain single-use materials.
  • The resulting data in the new BPSA guide demonstrates the equivalent impact of X-ray irradiation of single-use materials as gamma.
  • Advancing X-ray as a mode of sterilization is critical, for BPSA members and the broader bioprocessing industry."
  • Please contact BPSA Executive Director, Chris Clark, at [email protected] , and/or visit the BPSA website to download a copy of the white paper.

Ardelyx Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China

Retrieved on: 
Thursday, July 13, 2023
Chronic kidney disease, Fosun Pharma, Center for Drug Evaluation and Research, NDA, Patient, Hyperphosphatemia, National Medical Products Administration, NMPA, Pharmaceutical industry

This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma).

Key Points: 
  • This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma).
  • A potential approval of the NDA submission in China is expected by the end of 2024.
  • “I commend our collaboration partner, Fosun Pharma, on the impressive clinical results they generated which demonstrate the important role that tenapanor can play in offering a new treatment option for patients with hyperphosphatemia.
  • Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau.

FDA Converts Novel Alzheimer's Disease Treatment to Traditional Approval

Retrieved on: 
Thursday, July 6, 2023
Amyloid-related imaging abnormalities, Myenteric plexus, Hypersensitivity, Seizure, Neuron, Intracerebral hemorrhage, Bleeding, Clinical Dementia Rating, Center for Drug Evaluation and Research, Trial of the century, Disease, Clinical trial, Brain, Risk, Angioedema, Antibody, DSM-IV codes, Accelerated approval (FDA), Incidence, Anticoagulant, ARIA, Dizziness, Amyloid, Allergy, Patient, Swelling, Anaphylaxis, CLARITY, Peripheral, Nausea, Confusion, Research, FDA, Headache, Caregiver, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Medical imaging, Pharmaceutical industry, Alzheimer's disease, Lecanemab

SILVER SPRING, Md., July 6, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer's Disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit. Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer's disease. The drug works by reducing amyloid plaques that form in the brain, a defining pathophysiological feature of the disease. 

Key Points: 
  • Leqembi is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer's disease.
  • "This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer's disease."
  • Treatment was initiated in patients with mild cognitive impairment or mild dementia stage of disease and confirmed presence of amyloid beta pathology.
  • The labeling states that there are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.

Aquestive Therapeutics Provides Business Update and Announces Chief Medical Officer Appointment

Retrieved on: 
Thursday, June 29, 2023
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as Chief Medical Officer of the Company.

Key Points: 
  • as Chief Medical Officer of the Company.
  • “We are hopeful that this important subpopulation may benefit from Libervant in the near term,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • Dr. Kraus joins the Aquestive team from Aceragen, where he served as Chief Medical Officer from October 2021 to April 2023.
  • He previously served as Chief Medical Officer of Ology Bioservices (formerly Nanotherapeutics), which was acquired by National Resilience.

Zai Lab Announces NDA Acceptance of Repotrectinib for Patients with ROS1-positive NSCLC by China’s NMPA

Retrieved on: 
Wednesday, June 28, 2023
New Drug Application, NDA, Medicine, NSCLC, HKEX, Patient, National Medical Products Administration, CDE, Center for Drug Evaluation and Research, NMPA, Pharmaceutical industry

SHANGHAI, China and CAMBRIDGE, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for 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., June 28, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the National Medical Products Administration (NMPA) in China has accepted the New Drug Application (NDA) for repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
  • “We are pleased to obtain the NMPA’s acceptance of our NDA for repotrectinib, which further supports repotrectinib as a potential best-in-class treatment for patients with ROS1-positive NSCLC in China.
  • There is a significant unmet need for these patients given the limited durability of benefit, the emergence of resistance to approved therapies and eventual tumor progression,” said Rafael G. Amado, M.D., President, Head of Global Oncology Research and Development at Zai Lab.
  • “We look forward to collaborating with the NMPA during the review process in a joint effort to bring this important medicine to patients in need as soon as possible.”
    In May 2023, the Center for Drug Evaluation (CDE) of China’s NMPA granted priority review to repotrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

Spectral Medical Appoints Former FDA Director, Dr. David W. Feigal, Jr., to Its Board of Directors

Retrieved on: 
Tuesday, June 27, 2023
CDER, University of California, San Diego, Drug, Medicine, CDRH, University, Senior, Office of Inspector General, U.S. Department of Health and Human Services, Berkeley, Stanford University, Kirin-Amgen Inc v Hoechst Marion Roussel Ltd, Biotechnology, Public, FDA Center for Devices and Radiological Health, Septic shock, CDO, Bangladesh Technical Education Board, Sepsis, Food and Drug Administration, Public health, Partner, MD, Division, PMX, Center for Drug Evaluation and Research, TSX, Knowledge, FDA, Device, Biostatistics, Food, World Health Organization, European Medicines Agency, Pharmaceutical industry, Research

Dr. Feigal brings over four decades of experience in regulatory affairs and clinical research of medical devices, biologics, and products in multiple therapeutic areas.

Key Points: 
  • Dr. Feigal brings over four decades of experience in regulatory affairs and clinical research of medical devices, biologics, and products in multiple therapeutic areas.
  • He has an extensive track record of international regulatory success with the approval/clearance of medical products in numerous therapeutic areas.
  • “We are extremely proud to have Dr. Feigal join our Board of Directors,” commented, Anthony Bihl, Chairman of the Board at Spectral Medical.
  • We look forward to his contributions to Spectral and aiding in the advancement of PMX to market.”

Mobile Tech in Clinical Trials 10th Annual Conference to Report on the Tech that Worked for Patients During the Pandemic Organized by the Conference Forum

Retrieved on: 
Wednesday, June 21, 2023
CDER, Digital, CDRH, Novo Nordisk, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, FDA Center for Devices and Radiological Health, Innovation, Patient, Digital transformation, Motivation, Drug discovery, Merck, EMBA, Device, FDA, Pharmaceutical industry, Medical device, Research

NEW YORK, June 21, 2023 /PRNewswire-PRWeb/ -- The Conference Forum announced the launch of the 10th annual Mobile Tech in Clinical Trials conference taking place September 19, 2023 in Boston at the Westin Copley Place.

Key Points: 
  • "I am excited to be a part of this year's meeting because the patient is truly at the center.
  • Novo Nordisk's Head of US Digital Transformation and Innovation, Amy West, presents the 2023 Keynote with a report on the company's digital transformation journey.
  • "I look forward to hearing how our industry is using new advancements with mobile technologies in healthcare and research to benefit patients."
  • The 10th annual Mobile Tech in Clinical Trials will be followed by DPHARM: Disruptive Innovations to Modernize Clinical Research, September 20-22, 2023.

FDA Launches Pilot Program to Help Reduce Risks Associated with Using Laboratory Developed Tests to Identify Cancer Biomarkers

Retrieved on: 
Tuesday, June 20, 2023
Laboratory, Marketing, Center for Drug Evaluation and Research, Policy, FDA Center for Devices and Radiological Health, Cancer, Biomarker, Plasma protein binding, Patient, Risk, LDT, Device, Research, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Medical device, Pharmaceutical industry

SILVER SPRING, Md., June 20, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients.

Key Points: 
  • "The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments."
  • In oncology, for example, specific tests may be used to identify patients, such as those with a particular genetic mutation, who may or may not benefit from certain cancer treatments.
  • In these cases, tests offered as laboratory developed tests (LDTs) are being used for patient treatment decisions.
  • Laboratories may use this information to guide their development of LDTs to identify specific biomarkers used for selecting cancer treatment.