Subcutaneous injection

IHS Announces CE Mark Certification for Proprietary Syringe Infusion System

Retrieved on: 
Thursday, July 22, 2021
Hospitals, Health, Surgery, Medical devices, Health sciences, Medicine, Dosage forms, Pharmacology, Routes of administration, Injection, Medical equipment, Infusion pump, Infusion therapy, Intravenous therapy, ISO 13485, Subcutaneous injection

Innovative Health Sciences, LLC (IHS or the Company) announced today that they have received ISO 13485 quality management system and CE mark certification for the Insignis Syringe Infusion System.

Key Points: 
  • Innovative Health Sciences, LLC (IHS or the Company) announced today that they have received ISO 13485 quality management system and CE mark certification for the Insignis Syringe Infusion System.
  • The CE mark, abbreviated for European Conformity ("Conformit Europene"), enables IHS to sell the system throughout the European Union.
  • The Insignis Syringe Infusion System is the first combination of intravenous and subcutaneous non-electric infusion pump created for use with a selectable rate flow controller, the IV Controller and the OneSett.
  • The IHS infusion system addresses nearly every infusion therapy need and can support intermittent, pause dosing, ideal for lengthy low-volume hospital infusions.

Alnylam Announces New Data from ATTR Amyloidosis Programs at the Peripheral Nerve Society’s 2021 Annual Meeting

Retrieved on: 
Monday, June 7, 2021
Research, Surgery, Clinical trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Amyloidosis, Branches of biology, Health sciences, Health, Alnylam Pharmaceuticals, Familial amyloid polyneuropathy, Patisiran, Subcutaneous injection, Amyloid, ONPATTRO® (Patisiran), Vutrisiran, the HELIOS-A Phase 3 Study, hATTR Amyloidosis, RNAi, Alnylam Pharmaceuticals, ONPATTRO® (PATISIRAN), VUTRISIRAN, THE HELIOS-A PHASE 3 STUDY, HATTR AMYLOIDOSIS, RNAI, ALNYLAM PHARMACEUTICALS

These data were presented as posters during the 2021 Peripheral Nerve Societys Annual Meeting, and the HELIOS-A results will also be featured during the Richard A.C. Hughes - Clinical Science Highlights Presentation on Sunday, June 27th.

Key Points: 
  • These data were presented as posters during the 2021 Peripheral Nerve Societys Annual Meeting, and the HELIOS-A results will also be featured during the Richard A.C. Hughes - Clinical Science Highlights Presentation on Sunday, June 27th.
  • Patisiran also demonstrated an encouraging safety and tolerability profile after 12 months of treatment and there were no drug-related study discontinuations or deaths.
  • Vutrisiran is an investigational, subcutaneously administered RNAi therapeutic in development for the treatment of ATTR amyloidosis, which encompasses both hereditary (hATTR) and wild-type (wtATTR) amyloidosis.
  • Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

Liquidia Announces Generic Treprostinil Injection Now Also Available for Subcutaneous Route of Administration

Retrieved on: 
Monday, May 24, 2021
Prostaglandins, Secondary alcohols, Treprostinil, Dosage forms, Subcutaneous injection, Injection, Health, Chemistry, Physical sciences

Both options for intravenous and SC administration of Sandoz generic Treprostinil Injection are now available at the same specialty pharmacy that dispenses the brand name medicine.

Key Points: 
  • Both options for intravenous and SC administration of Sandoz generic Treprostinil Injection are now available at the same specialty pharmacy that dispenses the brand name medicine.
  • Patients who need and depend on subcutaneously administered treprostinil will now, for the first time, have access to a lower cost generic treprostinil.
  • The cartridges required to operate the CADD-MS 3 pump were not available to patients using generic Treprostinil Injection due to restrictions imposed by other companies.
  • CADD-MS 3 is a registered trademark of Smiths Medical ASD, Inc.
    Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration.

PharmaJet Presents Needle-free Delivery of COVID-19 DNA Vaccine Results at World Vaccine Congress

Retrieved on: 
Tuesday, April 27, 2021
Health, Medical devices, Infectious diseases, Clinical trials, Research, Science, Pharmaceutical, Injection, Clinical medicine, Medicine, Health sciences, Dosage forms, Routes of administration, Subcutaneous injection, Intradermal injection, Intramuscular injection, XC2, Vaccine, Cadila Healthcare

b'PharmaJet \xc2\xae, the maker of innovative, needle-free injection technology, announced that their latest research results will be presented at the World Vaccine Congress on May 6.

Key Points: 
  • b'PharmaJet \xc2\xae, the maker of innovative, needle-free injection technology, announced that their latest research results will be presented at the World Vaccine Congress on May 6.
  • The vaccine developed by Zydus Cadila is furthest along, with Phase III clinical trials in progress.
  • The innovative Stratis\xc2\xae Injector has U.S. FDA 510(k) marketing clearance, CE Mark and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously.
  • The Tropis\xc2\xae device for intradermal injections received authorization to apply the CE Mark in May 2016.

Liquidia Announces Generic Treprostinil Injection Will Be Available for Subcutaneous Route of Administration

Retrieved on: 
Tuesday, March 30, 2021
Prostaglandins, Secondary alcohols, Treprostinil, Routes of administration, Injection, Subcutaneous injection, Subcutaneous, Health, Chemistry, Physical sciences

We worked hard to overcome this obstacle, and we can now offer generic Treprostinil Injection to more than double the number of PAH patients.

Key Points: 
  • We worked hard to overcome this obstacle, and we can now offer generic Treprostinil Injection to more than double the number of PAH patients.
  • Since commercial launch two years ago, Treprostinil Injection has only been used for intravenous administration.
  • The cartridges required to operate the only subcutaneous pump that could deliver treprostinil injection (CADD-MS 3) were not made available to patients using generic treprostinil injection.
  • CADD-MS 3 is a registered trademark of Smiths Medical ASD, Inc.
    Treprostinil Injection is the first-to-file, fully substitutable generic treprostinil for parenteral administration.

 Insulet to Host an Investor Webcast to Discuss Omnipod® 5 Pivotal Data

Retrieved on: 
Tuesday, March 16, 2021
Diabetes, Health, Medical devices, Health, Clinical medicine, Insulin, Diabetes, Subcutaneous injection

The event will be hosted by Insulet and will include a presentation and an interactive question and answer session with the Companys covering sell side analysts.

Key Points: 
  • The event will be hosted by Insulet and will include a presentation and an interactive question and answer session with the Companys covering sell side analysts.
  • The link to the live call will be available on the Investor Relations section of the Companys website at http://investors.insulet.com , Events and Presentations, and will be archived for future reference.
  • Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform.
  • Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas.

ImmunityBio and NantKwest Begin Dosing Participants in Global Trials for Novel COVID-19 Vaccine; Subcutaneous Route in South Africa, Oral and Sublingual in the U.S.

Retrieved on: 
Monday, March 8, 2021
Health, Infectious diseases, Other Health, General Health, Clinical trials, Pharmaceutical, Biotechnology, Routes of administration, Dosage forms, Health sciences, Pharmacy, Pharmacology, Dose, Toxicology, Subcutaneous injection, Sublingual administration, Subcutaneous, ImmunityBio, NantKwest

In the three trials, the hAd5 vaccine candidate is being administered in a subcutaneous, oral, or sublingual formulation.

Key Points: 
  • In the three trials, the hAd5 vaccine candidate is being administered in a subcutaneous, oral, or sublingual formulation.
  • The Phase I trial in Cape Town, South Africa is using subcutaneous administration and nine participants have been dosed to date.
  • Phase Ib trials are studying a combination of subcutaneous/sublingual and subcutaneous/oral formulations; six participants have been dosed in each trial to date.
  • This novel design could address the multiple mutations occurring globally today, said Patrick Soon-Shiong, M.D., Executive Chairman of ImmunityBio and NantKwest.

James Sherblom Appointed Board Chairman to Lead ReForm Biologics’ New Business Strategy

Retrieved on: 
Thursday, February 25, 2021
Medical devices, Human resources, Professional services, Biotechnology, Physical therapy, Health, General Health, Other Science, Science, Dosage forms, Injection, Medicine, Clinical medicine, Health sciences, Routes of administration, Subcutaneous injection, Intravenous therapy, Subcutaneous

As well, James (Jim) Sherblom has joined the board of directors of ReForm as chairman to lead the shift in strategy.

Key Points: 
  • As well, James (Jim) Sherblom has joined the board of directors of ReForm as chairman to lead the shift in strategy.
  • Under the strategy announced today, ReForm will develop a bio-innovative medicine pipeline to convert hospital-based intravenous dosing to subcutaneous injections on an outpatient basis.
  • ReForm will manage therapeutic viscosity to reduce injection volumes and fluid injection force, greatly enhancing many therapeutics, including pediatric applications.
  • I am delighted join the team at ReForm to help lead this revolution in better patient care and improved clinical outcomes.

Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima™ SC, for the treatment of people with rheumatoid arthritis

Retrieved on: 
Monday, February 1, 2021
Drugs, Monoclonal antibodies, Immunosuppressants, TNF inhibitors, Infliximab, Janssen Biotech, Janssen Pharmaceutica, Subcutaneous injection, Heroin

"The approval of Remsima SC in Canada provides patients the opportunity to administer the treatment at home, giving physicians and patients more control over their treatment."

Key Points: 
  • "The approval of Remsima SC in Canada provides patients the opportunity to administer the treatment at home, giving physicians and patients more control over their treatment."
  • With the availability of the subcutaneous formulation of infliximab, patients could now be treated with a more personalized and convenient treatment option.
  • Remsima SC can be injected by patients themselves, which has the potential to save time since it will not require in-clinic administered IV treatment.
  • "We are delighted to bring the first subcutaneous form of infliximab to patients, payers and clinicians in Canada.

SecurAcath® Featured Prominently in New Infusion Therapy Standards

Retrieved on: 
Tuesday, January 26, 2021
Surgery, Health, Medical devices, Routes of administration, Articles, Infusion therapy, Medical device, Technical standard, Subcutaneous injection

Interrad Medical, a privately held medical device company, announces significant statements regarding use of SecurAcath in the recently published Infusion Therapy Standards of Care, 8th Edition.

Key Points: 
  • Interrad Medical, a privately held medical device company, announces significant statements regarding use of SecurAcath in the recently published Infusion Therapy Standards of Care, 8th Edition.
  • The standards refer extensively to subcutaneous anchor securement system (SASS) and SecurAcath is the only SASS in the world.
  • The INS Standards acknowledge this tested and validated technology brings a broad set of benefits including:
    The Infusion Therapy Standards are a well-respected, evidence-based document that are rigorously reviewed every five years.
  • We are proud to see the elevation of SecurAcath in the Infusion Therapy Standards of Practice.