Routes of administration

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.

Viatris Inc. and Kindeva Drug Delivery Announce FDA Tentative Approval of the First Abbreviated New Drug Application Generic Version of Symbicort® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol

Retrieved on: 
Monday, March 8, 2021
Health sciences, Health care, Drugs, Routes of administration, Viatris, Transdermal patch, Food and Drug Administration, Budesonide/formoterol, Transdermal, Nicotine replacement therapy

Viatris CEO Michael Goettler commented: "The FDA's tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients.

Key Points: 
  • Viatris CEO Michael Goettler commented: "The FDA's tentative approval of generic Symbicort represents yet another significant milestone for Viatris in advancing access to treatment for respiratory patients.
  • The FDA provided tentative approval at this time due to ongoing patent litigation.
  • Viatris and Kindeva are committed to bringing a generic Symbicort to market as soon as possible.
  • Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, microstructured transdermal systems (microsystems), and connected drug delivery.

Agile Therapeutics to Present at Upcoming March Investor Conferences

Retrieved on: 
Friday, March 5, 2021
Routes of administration, Health sciences, Medicine, Clinical medicine, Dosage forms, Transdermal patch, Transdermal

PRINCETON, N.J., March 05, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc.(Nasdaq: AGRX), a women's healthcare company, today announced that Chairman and Chief Executive Officer Al Altomari will present at two investor conferences in March.

Key Points: 
  • PRINCETON, N.J., March 05, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc.(Nasdaq: AGRX), a women's healthcare company, today announced that Chairman and Chief Executive Officer Al Altomari will present at two investor conferences in March.
  • Presentations from each conference will be webcast on the Investors section of the Agile Therapeutics website at https://ir.agiletherapeutics.com/events-and-presentations .
  • Twirla is based on our proprietary transdermal patch technology, called Skinfusion, which is designed to allow drug delivery through the skin.
  • The Company may occasionally disseminate material, nonpublic information on the Companys website.

PLx Pharma Inc. to Discuss 2020 Fourth Quarter Financial Results on March 12, 2021 Conference Call and Provide Business Update

Retrieved on: 
Thursday, March 4, 2021
Pharmacology, Health sciences, Drugs, Hepatotoxins, Routes of administration, Dosage forms, Pharmacokinetics, Aspirin, Pharma, Drug delivery, Modified-release dosage

A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International).

Key Points: 
  • A replay of the conference call will be available for two weeks after the call's completion by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International).
  • It also reduces the risk of stomach erosions and ulcers, as compared to immediate-release aspirin, common in an acute setting.
  • PLx Pharma Inc. is a late-stage specialty pharmaceutical company focused on its clinically-validated and patent-protected PLxGuard drug delivery platform to provide more effective and safer products.
  • The PLxGuard drug delivery platform works by targeting the release of active pharmaceutical ingredients to various portions of the gastrointestinal (GI) tract.

Japan Health System Improves Patient Safety with Adoption of NRFit™ Neuraxial Connectors, GEDSA Announces

Retrieved on: 
Thursday, February 25, 2021
Routes of administration, Medical device, Enteral administration

COLUMBUS, Ohio, Feb. 25, 2021 /PRNewswire-PRWeb/ -- All hospitals across Japan have completed adoption of ISO-compliant NRFit neuraxial connectors designed to improve patient safety by reducing the risk of medical device misconnections, the Global Enteral Device Supplier Association (GEDSA) announced today.

Key Points: 
  • COLUMBUS, Ohio, Feb. 25, 2021 /PRNewswire-PRWeb/ -- All hospitals across Japan have completed adoption of ISO-compliant NRFit neuraxial connectors designed to improve patient safety by reducing the risk of medical device misconnections, the Global Enteral Device Supplier Association (GEDSA) announced today.
  • NRFit replaces legacy connectors that are prone to wrong-route delivery of medication, which can result in patient injury or death.
  • To address patient safety concerns, the ISO standard used in NRFit (80369-6) was developed by international clinical, technical and regulatory experts in partnership with global manufacturers, suppliers and distributors.
  • Japan is now moving forward with adoption of ENFit enteral feeding devices made to the same rigorous global ISO standards.

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.

DisposeRx Drug Disposal Packets Now Accessible to All VA Medical Centers via GMP’s Medical Surgical Prime Vendor Program Award

Retrieved on: 
Thursday, February 18, 2021
White House, Federal Government, Public policy, Government, Law enforcement, Emergency services, State, Local, Health, Public policy, General Health, Health sciences, United States Department of Veterans Affairs, Routes of administration, Healthcare in the United States, Veterans Health Administration, Route of administration, Health care, Health, GMP, DisposeRx, Inc.

The Open Market Blanket Purchase Agreement Supplier award by the Veterans Health Administration streamlines procurement processes so that DisposeRx packets can be purchased by 172 VA Medical Centers, 1,062 outpatient sites, and other government agencies participating in the Medical Surgical Prime Vendor (MSPV 2.0) program.

Key Points: 
  • The Open Market Blanket Purchase Agreement Supplier award by the Veterans Health Administration streamlines procurement processes so that DisposeRx packets can be purchased by 172 VA Medical Centers, 1,062 outpatient sites, and other government agencies participating in the Medical Surgical Prime Vendor (MSPV 2.0) program.
  • "As a Veteran Owned business, finding solutions to improve the care of our current and former service members is central to our core values.
  • There is no other solution available to our veterans with the safety and convenience DisposeRx affords for at-home medication disposal.
  • DisposeRx at-home medication disposal packets are comprised of materials that are FDA-approved for oral medications and provide a simple, convenient and effective solution for the disposal of unused or expired medications.

Mallinckrodt Provides Regulatory Update on StrataGraft®

Retrieved on: 
Friday, February 12, 2021
Health sciences, Anatomy, Organs, Branches of biology, Clinical research, Routes of administration, Clinical trial, Design of experiments, Pharmaceutical industry, Human skin, Dermis, Mallinckrodt

An engineered, bilayer construct, StrataGraft is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers.

Key Points: 
  • An engineered, bilayer construct, StrataGraft is designed to mimic natural human skin with both inner dermis-like and outer epidermis-like layers.
  • Mallinckrodt is currently conducting a StrataGraft continued access clinical trial (StrataCAT, NCT04123548) under an Expanded Access Program (EAP).
  • Additionally, Mallinckrodt plans to conduct a study evaluating StrataGraft in the treatment of pediatric populations.
  • This release includes forward-looking statements concerning StrataGraft, including the regulatory review process, its potential impact on patients and anticipated benefits associated with its use, and future clinical trial plans.

Biogen Announces FDA Approval of PLEGRIDY® (peginterferon beta-1a) Intramuscular Administration for Multiple Sclerosis

Retrieved on: 
Monday, February 1, 2021
Clinical medicine, Multiple sclerosis, Health sciences, Medicine, Cytokines, Dosage forms, Routes of administration, Peginterferon beta-1a, Interferon beta-1a, Management of multiple sclerosis, Biogen, Subcutaneous

The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions.

Key Points: 
  • The new IM administration offers people living with relapsing MS the well-characterized efficacy and safety of PLEGRIDY with the potential for significantly reduced injection site reactions.
  • This approval expands Biogens industry-leading portfolio of MS treatments, which also includes the subcutaneous (SC) administration of PLEGRIDY, and follows the European Commissions marketing authorization for the IM administration in December 2020.
  • A phase 1, open-label, crossover study to evaluate the bioequivalence of intramuscular and subcutaneous peginterferon beta-1a in healthy volunteers.
  • Poster presented at: Americas Committee for Treatment and Research in Multiple Sclerosis - 2020 Forum; 2020 Feb 27-29; West Palm Beach, Florida, USA.

Hometa is thrilled to announce the recommendation of the use of electronic drop counters in the Infusion Therapy Standards of Practice 8th Edition

Retrieved on: 
Tuesday, January 26, 2021
Routes of administration, Infusion therapy

"there are also electronic drip monitors that can be used with a gravity administration set that provide more accurate rate monitoring.

Key Points: 
  • "there are also electronic drip monitors that can be used with a gravity administration set that provide more accurate rate monitoring.
  • 1,7,9,12-16 (IV)"
    The Infusion Therapy Standards of Practice have long been considered the authority on infusion practice, and for this technology to be endorsed by the INS represents a breakthrough in gravity infusion technology and viability.
  • The device has become integral in relieving the burden of supply shortages incurred by the COVID-19 pandemic.
  • DripAssist is exclusively available in the United States from Hometa Inc.
    For more information about DripAssist, please contact 877-2-HOMETA or visit https://hometa.com
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