US FDA

Pharmaceutical Compliance Audits: Adapting to Enhanced FDA Inspection Protocols, 2 Day Online Training Seminar

Retrieved on: 
Thursday, January 18, 2024
Letter, External, U.S. FDA, CGMP, US FDA, Internal, FDA, Notification, Audit

Factor US FDA compliance inspection emphasis into the company's audit preparedness and replicate key points for internal and supplier audits.

Key Points: 
  • Factor US FDA compliance inspection emphasis into the company's audit preparedness and replicate key points for internal and supplier audits.
  • Using the field tested techniques presented in this seminar, an internal and/or supplier audit can provide much the same early warnings as a real FDA compliance cGMP audit.
  • This seminar will provide test scripts and rationale for a 'model' for company internal and supplier audits.
  • It will describe a 'typical' US FDA inspection, and points to replicate with an internal audit or supplier audit.

Biomerica Reports Second Quarter 2024 Financial Results

Retrieved on: 
Tuesday, January 16, 2024
US FDA, Stomach, COVID-19, Helicobacter pylori, IBS, FDA, Bacteria, GI, Growth, Vaccine

Revenues excluding Covid test sales increased 10.3% for the second fiscal quarter of 2024 vs the second fiscal quarter of 2023.

Key Points: 
  • Revenues excluding Covid test sales increased 10.3% for the second fiscal quarter of 2024 vs the second fiscal quarter of 2023.
  • IRVINE, Calif., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products today reported financial results for the second quarter of fiscal 2024 ended November 30, 2023.
  • Net sales for the fiscal second quarter 2024 were $1.6 million, up from $1.5 million for the fiscal second quarter of 2023.
  • Further, net sales for the fiscal second quarter 2024 were 6.7% higher than sales during fiscal second quarter of 2023.

Sagard Healthcare Announces Closing of Credit Facility and Recent Investment Highlights

Retrieved on: 
Thursday, January 4, 2024
Biotechnology, Commercial Building & Real Estate, Construction & Property, FDA, Professional Services, Health, Pharmaceutical, Medical Devices, Health Insurance, Asset Management, Finance, US FDA, Professional corporation, Health care, United Therapeutics, Partner, Helicobacter pylori, MannKind Corporation, Therapy, Pulmonary hypertension, Esophagitis, Growth, Investment, Dostarlimab, Orthostatic hypertension

Sagard Healthcare – a biopharmaceutical royalty and credit investor – today announced several developments and milestones for the strategy, including the closing of a $250 million permanent credit facility and the completion of nearly $250 million of new investments.

Key Points: 
  • Sagard Healthcare – a biopharmaceutical royalty and credit investor – today announced several developments and milestones for the strategy, including the closing of a $250 million permanent credit facility and the completion of nearly $250 million of new investments.
  • Sagard Healthcare invests in approved and medically-necessary biopharmaceuticals, medical devices, and diagnostics through royalty monetization, revenue interest financing and secured credit investments.
  • Sagard is pleased to announce that in December 2023, it closed a $250 million revolving credit facility with a syndicate of lenders.
  • The facility is expected to grow in size as Sagard continues to expand its portfolio of royalty and credit investments.

Enspectra Health Announces US FDA Clearance of VIO‎™ System, First of Its Kind Technology to Visualize Skin Cellular Structures in Real-Time

Retrieved on: 
Wednesday, January 3, 2024
Dermatology, US FDA, Physician, Histology, Epidermis, FDA, Blood, Trial of the century, Collagen, Marie Cassidy, Pathology, VIO, Algorithm, Skin, Medical imaging

MOUNTAIN VIEW, Calif., Jan. 3, 2024 /PRNewswire/ -- Enspectra Health, a health tech company, announces US FDA 510(k) clearance of the VIO System, launching a new era in noninvasive imaging.

Key Points: 
  • MOUNTAIN VIEW, Calif., Jan. 3, 2024 /PRNewswire/ -- Enspectra Health, a health tech company, announces US FDA 510(k) clearance of the VIO System, launching a new era in noninvasive imaging.
  • VIO, the first of its kind technology, combines reflectance confocal and multiphoton microscopy to enable cellular resolution, cross-sectional imaging of skin in seconds.
  • Easily portable and handheld, VIO digitizes pathology directly from a patient's skin to provide clinical insights for physicians.
  • This is the first multiphoton imaging modality to ever be cleared by the FDA," said Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health.

2 Day Virtual Training Course on Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems

Retrieved on: 
Tuesday, December 19, 2023
Phase, RAC, CGMP, US FDA, MDR, Risk, CFR, Cosmetic, CAPA, FD, Medicine, FDA, QSR, RAPS, Complaint, Public, Safety, Medical device

DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" course has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • DUBLIN, Dec. 19, 2023 /PRNewswire/ -- The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems" course has been added to ResearchAndMarkets.com's offering.
  • This formal postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.
  • A more generalized "post market surveillance"/complaint handling is also a requirement under the device CGMPs, 21 CFR 820, -.100 - CAPA, and -.198 - Complaints.
  • "Postmarket Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act", Guidance, dated October 2022
    21 CFR 822 - Implementing Sec.

Third Success from Astex Drug Discovery Pharma Collaboration and Licence Agreements as AstraZeneca Receives US Marketing Approval for Cancer Drug Truqap (capivasertib)

Retrieved on: 
Monday, November 20, 2023
Sale, Institute of Cancer Research, Translation, Research, AstraZeneca, Food, US Foods, PIK3CA, Mouse, Patient, PTEN, FDA, PKB, Marketing, Neoplasm, CRT, Therapy, US FDA, Drug discovery, AKT, Cancer, 3D, AKT1, Central nervous system, Recurrence, ICR, Pharmaceutical industry, Astex Pharmaceuticals

CAMBRIDGE, United Kingdom, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Astex Pharmaceuticals (UK), a pharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced today that it is in line to receive a milestone payment from AstraZeneca on first commercial sale of the drug in the US and royalties from AstraZeneca on future sales following the US Food and Drug Administration’s (FDA) approval of Truqap™ plus Faslodex® as a treatment for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

Key Points: 
  • This is the third cancer drug in the last five years to reach market approval that has been discovered and developed under, or subsequent to, an Astex drug discovery collaboration.
  • Truqap was discovered by AstraZeneca following an earlier drug discovery research collaboration between Astex, The Institute of Cancer Research, London, and Cancer Research Technology (CRT; now Cancer Research Horizons) that was signed in 2003.
  • In 2010, AstraZeneca announced its discovery of Truqap, and began to develop the drug as a potential treatment for various forms of cancer.
  • This is also a great example of UK Biotech-Academia-Pharma collaboration and underlines the strength of the UK life sciences ecosystem.”
    Graphic of the hat-trick of three marketed cancer drugs discovered and developed under, or subsequent to, an Astex drug discovery collaboration with pharma

ABVC BioPharma Reports Third Quarter 2023 Financial and Operational Results

Retrieved on: 
Wednesday, November 15, 2023
CNS, Sale, CSMC, Retina, Patient, Triple-negative breast cancer, Attention deficit hyperactivity disorder, Cayman, Investigational New Drug, US FDA, Licensed production, Cancer, Power purchase agreement, SIV, Security (finance), Toxicity, Plasma protein binding, Syndrome, IND, Surgeon, TGA, BioLite, ADHD, Taiwan Stock Exchange, Sales management, Hydrogel, MDD, Pancreatic cancer, Depression, GMP, Good manufacturing practice, Bank statement, UCSF, MDS, University, Partnership, Phase, Drug development, Research, ANDA, Warrant, FDA, Dietary supplement, West Pharmaceutical Services, Share (finance), Pharmaceutical industry, Cryptocurrency, Qiu Zhonghui

FREMONT, CA, Nov. 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"): Today, a biotechnology company specializing in botanically based solutions that deliver high efficacy and low toxicity to improve health outcomes announced its financial and operating results for the third quarter of 2023.

Key Points: 
  • FREMONT, CA, Nov. 15, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC) ("Company"): Today, a biotechnology company specializing in botanically based solutions that deliver high efficacy and low toxicity to improve health outcomes announced its financial and operating results for the third quarter of 2023.
  • During July 2023, the warrant exercise price was reset to $3.5 under the issuance of common stock about securities purchase agreement on July 2023.
  • During the third quarter of 2023, the Company issued to Zhonghui an aggregate of 370,000 shares of the Company's common stock at a per-share price of $20.
  • "We are delighted with our remarkable accomplishments and meaningful progress in 2023, and look forward to upcoming reports to end 2023 on a positive note," said Uttam Patil, Ph.D., Chief Executive Officer of ABVC BioPharma.

Samsung Ushers in a New Era of Diagnostic Solutions at RSNA 2023

Retrieved on: 
Tuesday, November 21, 2023
Biotechnology, Technology, Other Health, Health, General Health, Radiology, Health Technology, Other Technology, Medical Devices, Mobile, Wireless, Hardware, Photon, X-ray, RSNA, Neck, Associate, Next Generation, Research, Annual general meeting, Steven Novella, Head, University, ICU, Level 4, PCD, Patient, Multimedia, Samsung Electronics, McCormick Place, Neuroradiology, FDA, Stroke, Booth, US FDA, MD, Harvard Medical School, Trauma, VMI, Massachusetts General Hospital, Doctor of Philosophy, CST, Samsung, Hospital, MCT, Medical imaging, Medical device

View the full release here: https://www.businesswire.com/news/home/20231121501923/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231121501923/en/
    The high-tech, yet highly mobile OmniTom Elite with Photon Counting Detector (PCD) CT scanner is designed to offer advanced imaging at the point-of-care.
  • In the near term, all current OmniTom users will have the opportunity to upgrade their scanners with the PCD technology.
  • Meanwhile, a limited number of premier research partners will aid in developing the full potential of OmniTom Elite with PCD.
  • OmniTom Elite with PCD is only supported for adult axial imaging for head and neck.

2 Day Virtual Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Seminar: U.S. FDA CGMP Expectations/Requirements for Post Market Surveillance and Complaint Handling - ResearchAndMarkets.com

Retrieved on: 
Friday, November 17, 2023
Education, FDA, Training, Health, CGMP, Complaint, Safety, CGMP-specific phosphodiesterase type 5, CFR, CAPA, RAPS, MDR, Risk, DHF, US FDA, RAC, Phase, Failure, QSR, FD, Public, Medical device

The "Establish a Compliant Medical Device Post Market Surveillance and Complaint Handling System" training has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Establish a Compliant Medical Device Post Market Surveillance and Complaint Handling System" training has been added to ResearchAndMarkets.com's offering.
  • This formal postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device.
  • A more generalized "post-market surveillance" / complaint handling is also a requirement under the device CGMPs, 21 CFR 820, -.100 - CAPA, and -.198 - Complaints.
  • Data collected under post-market surveillance helps to address important public health questions on the safety and effectiveness of a device, often resulting in improvements in device design and manufacture.

Stem Cell Therapy Market Worth $615 Million | MarketsandMarkets

Retrieved on: 
Tuesday, December 12, 2023
Microsoft Exchange Server, DSM-IV codes, Research, Prevalence, Takeda Pharmaceutical Company, IND, RTI Surgical, Investment, NuVasive, Market development, Patient, ALS, PVT, COVID-19, Stem cell, Master of ceremonies, US FDA, Technical, Cancer, Pulse, RESEARCH, Growth, Embryonic stem cell, Ethics, Adipose tissue, Silk, Veterinary medicine, Pharmaceutical industry

The global stem cell therapy market is segmented into adipose tissue-derived MSCs, bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources.

Key Points: 
  • The global stem cell therapy market is segmented into adipose tissue-derived MSCs, bone marrow-derived MSCs, placenta/umbilical cord-derived MSCs, and other cell sources.
  • Stem Cell Therapy Market Dynamics:
    Key Market Players of Stem Cell Therapy Industry:
    The stem cell therapy market is competitive, with a small number of players competing for market shares.
  • Stem Cell Therapy Market - Key Benefits of Buying the Report:
    The report will help market leaders/new entrants by providing them with the closest approximations of the revenue numbers for the overall stem cell therapy market and its subsegments.
  • The report provides insights on the following pointers:
    Analysis of key drivers (Increased funding for stem cell research, rise in collabrations and partnerships is likley to uplift the market growth, Increasing clinical trials for stem cell based-therapies), restraints ( Ethical concerns related to embryonic stem cells, high cost of cell-based research), opportunities (The emergence of iPSCs as an alternative to ESCs, growing demand for stem cell and gene therapy) and challenges (Technical limitations) are influencing the growth of stem cell therapy market.