Combination product

NEUMA, The Design And Testing Arm Of Kymanox, Moves To New Headquarters

Retrieved on: 
Thursday, January 5, 2023
CISS, Medical device, AAMI, Ciccarelli, Medical device design, Association for the Advancement of Medical Instrumentation, Certification, Quality management system, DV, Radiation, QMS, Development, Electrical engineering, Software, FDA, First Avenue, Specialization, Device file, Combination product, Engineering, Sterilization

The new NEUMA headquarters provides a significant upgrade in meeting space for customer engagement as well as expanded lab space for prototyping and testing.

Key Points: 
  • The new NEUMA headquarters provides a significant upgrade in meeting space for customer engagement as well as expanded lab space for prototyping and testing.
  • In particular, this new space enables the Kymanox Lab Services function to offer full-service Design Verification (DV) Testing activities, from early-stage test method development through method validation and DV execution.
  • In addition to design and testing services, NEUMA continues to expand its service offerings particularly in the field of sterilization engineering.
  • Verifying device requirements through formal performance testing is a major milestone for combination product and medical device programs.

First Nasally-Administered Pharmaceutical Treatment for Dry Eye Disease Approved by US FDA with Aptar’s Nasal Pump System

Retrieved on: 
Monday, October 25, 2021
Packaging, FDA, Health, Manufacturing, General Health, Optical, Science, Duane syndrome, Financial condition report, Engineering, Securities Act of 1933, Nasal spray, Administration, AptarGroup, Drug development, Vaccination, CNS, ATR, Analysis, U.S. Securities and Exchange Commission, Patient, Security (finance), FDA, Result, NYSE, Nose, American Journal, U.S. FDA, Homeostasis, Technology, Forward-looking statement, Food, Nasal mucosa, CEO, American Journal of Ophthalmology, Combination product, Multimedia, Regulatory affairs, Allergic rhinitis, Dry eye syndrome, Pain, Drug Quality and Security Act, Beauty, Health, Risk, CPS, Prevalence, Securities Exchange Act of 1934, MG1, Form, Pharmaceutical industry, Animal, Dry Eye Disease, Aptar, DRY EYE DISEASE, APTAR

View the full release here: https://www.businesswire.com/news/home/20211025005101/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20211025005101/en/
    TYRVAYA, a highly selective cholinergic agonist, is the first nasally-administered pharmaceutical therapy to treat the signs and symptoms of dry eye disease to have been approved by the U.S. FDA.
  • This approval makes Aptars Cartridge Pump System a key component of the first and only U.S. FDA-approved pharmaceutical therapy to deliver treatment for the signs and symptoms of dry eye disease, an ophthalmic condition, via the nasal route and re-confirms Aptars expertise for developing innovative drug delivery solutions.
  • We are pleased that our proven CPS nasal system is now a multidose delivery option for patients suffering from dry eye disease.
  • Dry eye disease is a multifactorial chronic disease of the ocular surface characterized by a loss of homeostasis of the tear film, resulting in a multitude of symptoms.

EdgeOne Medical Again Named Top 10 Medical Device Testing and Certification Company by MedTech Outlook

Retrieved on: 
Wednesday, September 2, 2020
Articles, Health, Medicine, ISO 13485, Medical equipment, Medical technology, Pharmaceutical industry, Validity, Quality, Medical device, Validation, Combination product

EdgeOne Medical was recognized for its ISO 13485 certified and FDA compliant Medical Device and Combination Products Testing Lab that provides verification, validation and performance testing in hardware and software for global requirements.

Key Points: 
  • EdgeOne Medical was recognized for its ISO 13485 certified and FDA compliant Medical Device and Combination Products Testing Lab that provides verification, validation and performance testing in hardware and software for global requirements.
  • Many of the top 50 global biopharma, medical device and combination product companies choose EdgeOne for integrated product development services.
  • EdgeOne Medical's CEO Lilli Zakarija, a 20-year bioscience and medical device veteran says, "We are honored to be selected again by MedTech Outlook.
  • Being recognized for our ISO 13485 certified and FDA compliant testing services further positions EdgeOne Medical as a leader in integrated product development," says Zakarija.

Orchestra BioMed™ Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs

Retrieved on: 
Tuesday, April 28, 2020
Health, Articles, Medical device, Food and Drug Administration, Pharmaceutical industry, Combination product, AstraZeneca

Mr. Laughner will play a lead role in advancing Orchestra BioMeds VirtueSirolimus AngioInfusion Balloon (SAB) through global regulatory approvals.

Key Points: 
  • Mr. Laughner will play a lead role in advancing Orchestra BioMeds VirtueSirolimus AngioInfusion Balloon (SAB) through global regulatory approvals.
  • Mr. Laughner brings over a decade of leadership experience in combination product development and successful implementation of regulatory strategies for global medical device and biopharmaceutical companies.
  • Before joining Orchestra BioMed, he served as the Regulatory Director, Medical Device and Combination Products at AstraZeneca, where he drove combination product regulatory strategies across the product portfolio.
  • In this role, Mr. Laughner managed combination product regulatory submissions and meetings with the FDA and other global regulatory agencies, while also evaluating new technologies and implementing guidelines for their development, regulatory approval and life-cycle management.

Phillips-Medisize Wins Contract to Manufacture First Electronic-Enabled Combination Drug Delivery Product

Retrieved on: 
Tuesday, October 22, 2019
Technology, Managed care, Medical devices, General Health, Medical Supplies, Diabetes, Other Manufacturing, Health, Semiconductor, Chemicals, Plastics, Other Technology, Manufacturing, Software, Other Health, Hardware, Pharmaceutical, Data management, Lisle, Illinois, Molex, Combination product, Combination drug, Companies

Phillips-Medisize, a Molex company , announced today an agreement with a leading biotechnology company to manufacture a wearable, electronic-enabled combination product.

Key Points: 
  • Phillips-Medisize, a Molex company , announced today an agreement with a leading biotechnology company to manufacture a wearable, electronic-enabled combination product.
  • The product is a post-phase III development-stage combination drug and device that combines two-day, single use, disposable technology for subcutaneous drug delivery.
  • Several state-of-the-art Phillips-Medisize facilities are involved in various stages of manufacturing the combination product including molding, assembly, drug handling, labeling, reconciliation and more.
  • This exciting new contract taps over 13 years of Phillips-Medisizes combination product expertise, which includes cold chain drug handling and first programs with API handling.

The global drug device combination product market size is expected to reach USD 177.7 billion by 2024

Retrieved on: 
Wednesday, June 27, 2018
Medicine, Pharmacology, Health, Dosage forms, Interventional cardiology, Drug-eluting stent, Transdermal patch, Inhaler, Stent, Combination product, Market penetration

NEW YORK, June 27, 2018 /PRNewswire/ -- Drug Device Combination Products Market Size, Share & Trends Analysis Report By Product (Transdermal Patches, Infusion Pumps, Inhalers, Drug Eluting Stents, Antimicrobial Catheters), And Segment Forecasts, 2018 - 2024

Key Points: 
  • NEW YORK, June 27, 2018 /PRNewswire/ -- Drug Device Combination Products Market Size, Share & Trends Analysis Report By Product (Transdermal Patches, Infusion Pumps, Inhalers, Drug Eluting Stents, Antimicrobial Catheters), And Segment Forecasts, 2018 - 2024
    The global drug device combination product market size is expected to reach USD 177.7 billion by 2024 clocking in a 7.9% CAGR during the forecast period.
  • Rising demand for minimally invasive techniques due to enhanced patient outcomes associated with it is the high impact-rendering driver of this market.
  • Further key findings from the study suggest:
    Key market players are engaged in various strategies such as new product launch and distribution agreements to gain market penetration.
  • Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

Drug Device Combination Product Market Worth $177.7 Billion by 2024: Grand View Research, Inc.

Retrieved on: 
Wednesday, June 13, 2018
Combination product

The global drug device combination product market size is expected to reach USD 177.7 billion by 2024, according to a new report by Grand View Research, Inc., clocking in a 7.9% CAGR during the forecast period.

Key Points: 
  • The global drug device combination product market size is expected to reach USD 177.7 billion by 2024, according to a new report by Grand View Research, Inc., clocking in a 7.9% CAGR during the forecast period.
  • Rising demand for minimally invasive techniques due to enhanced patient outcomes associated with it is the high impact-rendering driver of this market.
  • Browse related reports by Grand View Research:
    Medical Sensors Market - The global medical sensors market size was valued at USD 9.4 billion in 2015.
  • Grand View Research has segmented the global drug device combination product market on the basis of product type and region:
    Drug Device Combination Product Outlook (Revenue, USD Billion,2013 - 2024)