Intramuscular Administration News
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FDA Emerging Technology Program
Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in ...
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Zeneo® Adrenaline: A New Innovative Formulation
Anaphylactic shock is an absolute medical emergency. When anaphylactic shock is suspected, emergency services must be called and emergency first aid administered immediately. The only first-line treatment for anaphylactic shock is injectable adrenaline1. In the USA: 1.6% to 5.1% of the population has experienced anaphylactic shock, 1% of hospitalizations are caused by it, 0.1% of patients ...
By Crossject
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Treatment of Prostatitis - What Forms of Medicines Released?
Prostatitis is a disease characterized by the presence of inflammation and/or infection localized in the prostate gland. ...
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Enalare Therapeutics Receives Orphan Drug Designation From the U.S. FDA on ENA-001 for the Treatment of Apnea of Prematurity (AoP)
ENA-001, a New Chemical Entity (NCE) with a novel mechanism of action as an agnostic respiratory stimulant, has previously been granted Rare Pediatric Disease designation for the Treatment of AoP by the FDA, with eligibility for a priority review voucher (PRV). The compound is also being developed by Enalare for the treatment of post-operative respiratory depression and community drug overdose. ...
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Enalare Therapeutics Receives an Additional Award Worth Up to $50 Million From BARDA, Expanding Its Partnership in Development of ENA-001
The Funding Will Accelerate Development of an Intramuscular Formulation of ENA-001, a Novel Agnostic Respiratory Stimulant, for the Potential Treatment of Community Drug Overdose and as a Medical Countermeasure for Mass Casualty Events. The Funding Supports Development of an Intramuscular ENA-001 From Pre-Clinical Toxicology Through Filing for Approval in the United States Enalare Therapeutics ...
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Phase 1 clinical trial: delNS-based immunotherapy against HPV 16
Viennese biotechnology company BlueSky Immunotherapies GmbH (Ltd.) has completed the second cohort of its phase 1 clinical trial against HPV 16. The results: Intradermal administration has been confirmed to be safe and well tolerated. Preliminary indications of efficacy were observed. Their proprietary innovative delNS technology for interferon-inducing viral vectors is a next-generation ...
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Eagle Pharmaceuticals Takes Equity Stake in, with Option to Acquire, Enalare Therapeutics to Advance Global Development of ENA-001, a Novel Agnostic Respiratory Stimulant
ENA-001 is currently in development for: post-operative respiratory depression, community drug overdose, and Apnea of Prematurity Approval for post-operative respiratory depression expected in 2026 and community drug overdose thereafter ENA-001 works peripherally by inhibiting Big Potassium (BK) ion channels in the carotid bodies, which are located in the neck. By inhibiting these channels, ...
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Micron Biomedical Presents at the White House Summit on the Future of COVID-19 Vaccines
Dr. Mark Prausnitz, co-founder and Chief Scientific Advisor of Micron Biomedical (“Micron”), today presented Micron’s technology for the simple administration of vaccines and therapeutics at a White House panel discussion titled Innovation in Vaccine Delivery chaired by Dr. Francis Collins. This summit outlined a path toward innovative, next-generation COVID-19 vaccines and ...
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Preclinical Data on Novel Arenaviral HIV Therapeutic Vaccines Presented at Keystone Symposium
Oral and poster presentations highlight robust and high-quality immune responses following administration of novel arenaviral therapeutic vaccines in preclinical setting Alternating 2-vector therapy induces greater immune response than single-vector therapy in preclinical setting and translates into significant reduction of viral load HOOKIPA Pharma Inc. (NASDAQ: HOOK, ...
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Enalare Files Additional Patent Application for Lead Compound ENA-001 - Enhancing Potential Global Exclusivity Through 2042
Enalare Therapeutics Inc., a biopharmaceutical company dedicated to developing novel therapies for patients suffering from life-threatening critical care conditions, announced today that it has filed a Provisional Patent Application with the United States Patent and Trademark Office directed to parenteral formulations of ENA-001 and related compounds. The patent application encompasses the ...
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INOVIO Collaborates with GuardRX and Geneva University Hospitals for Heterologous Booster Clinical Trial of its Ebola DNA Vaccine Candidate, INO-4201
INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that several volunteers have been dosed with its DNA-based, intradermal Ebola vaccine candidate, INO-4201, as part of a randomized, placebo-controlled, Phase 1b clinical trial ...
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BlueWillow Biologics Announces Positive Interim Results from Phase 1 Trial of Intranasal Anthrax Vaccine
BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines, today announced positive interim results from the Phase 1 clinical trial of BW-1010, its next-generation intranasal anthrax vaccine candidate. BW-1010 combines BlueWillow’s patented technology, a novel oil-in-water emulsion platform that efficiently presents antigens to the ...
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Virometix Announces Publication of Key Non-Clinical Proof-ofConcept Data in Two High Quality Peer-Reviewed Journals
Virometix, a privately held Swiss biotechnology company developing a new generation of vaccines and immunotherapeutic drugs for the prevention and treatment of infectious diseases and cancer conditions, today announces publication of key non-clinical proof-of-concept data on its lead vaccine candidate V-306 in two high quality peer-reviewed journals. The data confirm the potential of V-306 for ...
By Virometix AG
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Medigen and BlueWillow Biologics Partner to Develop Intranasal Vaccine for SARS-CoV-2
Medigen Vaccine Biologics Corporation (MVC) (TPEx: 6547.TWO), a biopharmaceutical company focusing on the development and production of vaccines and biologics, and BlueWillow Biologics, Inc., a privately held clinical-stage biopharmaceutical company developing intranasal vaccines through its patented NanoVax™ adjuvant, today announced a partnership to develop S-2P-NE-01, a nasal vaccine for ...
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ViciniVax announces first patient treated in Phase I study with immunotherapy Vvax001 for HPV-related precancers and cancer
Groningen, the Netherlands - 3 February 2017 - ViciniVax, a Dutch biopharmaceutical company in Groningen, announced today the treatment of the first patient with Vvax001 in a Phase I study in patients with a history of cervical intraepithelial neoplasia (CIN) 2 and 3 or cervical cancer. The Phase I study is an investigator-initiated Phase I clinical trial conducted by the Department of Obstetrics ...
By ViciniVax BV
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Royal Government of Bhutan, Merck and Australian Cervical Cancer Foundation partner on vaccination program with GARDASIL(R) for girls and young women of Bhutan
The Royal Government of Bhutan, Merck (which is known as MSD outside the United States and Canada) and the Australian Cervical Cancer Foundation (ACCF) today launched a national vaccination program with GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] for appropriate girls and young women in Bhutan. In an effort to reduce the burden of cervical cancer, ...
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