Otitis media

US WorldMeds Announces FDA Approval of IWILFIN™ (eflornithine) to Strengthen Fight Against Aggressive Childhood Cancer

Retrieved on: 
Thursday, December 14, 2023
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High-risk neuroblastoma is a challenging disease, with a high mortality rate driven primarily by the risk of relapse after achieving remission.

Key Points: 
  • High-risk neuroblastoma is a challenging disease, with a high mortality rate driven primarily by the risk of relapse after achieving remission.
  • US WorldMeds partnered with the Beat Childhood Cancer Research Consortium at Penn State University, which conducted the preclinical and clinical research to help advance this vital therapy.
  • The Consortium represents a group of over 50 hospitals that offer collaboration through a network of childhood cancer clinical trials.
  • “We are thankful for the dedication of our partners, specifically the Beat Childhood Cancer Research Consortium, who work tirelessly to improve treatment outcomes for pediatric cancer patients.

New Enhancements and Advancements in the Companion Animal Ear Infection Treatment Market 2023-2030 - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 23, 2023
Pharmaceutical, Health, Veterinary, Cats and Dogs, Pressure, High, Research report, Block cipher mode of operation, Labyrinthitis, Dog, COVID-19, Consumer, Research, USD, Cat, Certification, Compound annual growth rate, Otitis externa, Social impact assessment, Investment, Quinolone antibiotic, Oral, R, Vaccine, Pharmaceutical industry, Pet industry, Topical medication, Aminoglycoside, Otitis media

The Cumulative Impact of COVID-19, the Russia-Ukraine Conflict, and High Inflation is expected to have significant long-term effects on the Global Companion Animal Ear Infection Treatment Market.

Key Points: 
  • The Cumulative Impact of COVID-19, the Russia-Ukraine Conflict, and High Inflation is expected to have significant long-term effects on the Global Companion Animal Ear Infection Treatment Market.
  • Which are the products/segments/applications/areas to invest in over the forecast period in the Global Companion Animal Ear Infection Treatment Market?
  • What is the market share of the leading vendors in the Global Companion Animal Ear Infection Treatment Market?
  • What modes and strategic moves are considered suitable for entering the Global Companion Animal Ear Infection Treatment Market?

Blue Water Biotech Expands Commercial Portfolio by Acquiring Six FDA-Approved Drugs Across Various Treatment Areas

Retrieved on: 
Wednesday, June 14, 2023
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Under the terms of the Agreement, Blue Water Biotech, Inc. (“Blue Water” or the “Company”) will purchase the WraSer Assets for a total of $8.5 million cash consideration payable in three tranches: at signing, upon closing and within one year of closing.

Key Points: 
  • Under the terms of the Agreement, Blue Water Biotech, Inc. (“Blue Water” or the “Company”) will purchase the WraSer Assets for a total of $8.5 million cash consideration payable in three tranches: at signing, upon closing and within one year of closing.
  • In addition, WraSer shall receive 1.0 million restricted shares of Blue Water’s common stock on the closing date.
  • The closing of the transaction is subject to certain customary closing conditions, as well as WraSer’s delivery of 2022 audited financial statements for WraSer’s parent company, Legacy-Xspire Holdings, LLC, to Blue Water.
  • Blue Water will assume management of the WraSer Assets during the audit period.

U.S. FDA Approves PREVNAR 20®, Pfizer’s 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

Retrieved on: 
Thursday, April 27, 2023
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“Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children,"1,2 said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.

Key Points: 
  • “Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children,"1,2 said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.
  • “This important PREVNAR 20 approval builds on more than 20 years of real-world impact with PREVNAR and PREVNAR 13, safety data, and effectiveness; highlighting Pfizer's leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life threatening infections.
  • "We are thrilled with this approval as it signifies a new chapter in pediatric pneumococcal conjugate vaccination.
  • Further positive data from a Proof-of-Concept Phase 2 study (NCT03512288) that assessed the safety and immunogenicity of PREVNAR 20 also supported the FDA’s decision.

Matrivax Initiates Phase 1 Clinical Development of MVX01, a Novel Pneumococcal Vaccine Candidate

Retrieved on: 
Thursday, March 16, 2023
Health, Infectious Diseases, General Health, Research, Science, Pharmaceutical, Biotechnology, Vaccine, Antigen, Community-acquired pneumonia, Streptococcus, FHI, Vaccination, Public, Fatality, Streptococcus pneumoniae, Trial of the century, Otitis media, Sinusitis, Death, Fungal infection, Epitope, Immunodeficiency, Meningitis, Safety, Disease

Vaccine development company Matrivax announces the start of its Phase 1 clinical study to assess the safety, tolerability, and immunogenicity of its lead pneumococcal disease vaccine candidate, MVX01.

Key Points: 
  • Vaccine development company Matrivax announces the start of its Phase 1 clinical study to assess the safety, tolerability, and immunogenicity of its lead pneumococcal disease vaccine candidate, MVX01.
  • We’ve engineered the vaccine to present antigens to the vaccinee that are highly conserved across the >100 wild-type serotypes that cause pneumococcal disease.
  • This vaccine candidate provides the real opportunity of a vaccine that can immunize against the broad spectrum of disease-causing strains.
  • We are delighted to now start clinical development of the vaccine in human subjects with our clinical research partner, FHI Clinical.”

U.S. FDA Accepts Biologics License Application for Pfizer’s Respiratory Syncytial Virus Maternal Vaccine Candidate for Priority Review

Retrieved on: 
Tuesday, February 21, 2023
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The FDA has accepted the BLA for priority review and has set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.

Key Points: 
  • The FDA has accepted the BLA for priority review and has set a Prescription Drug User Fee Act (PDUFA) action date of August 2023.
  • The PDUFA goal date for a decision by the FDA on the MenABCWY application is in October 2023.
  • If approved and recommended, MenABCWY could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine.
  • Top-line results from a randomized, active-controlled, and observer-blinded Phase 3 trial of Pfizer’s pentavalent meningococcal vaccine candidate (NCT04440163) were previously announced in September 2022.

U.S. FDA Accepts for Priority Review the Supplemental Biologics License Application for Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine in Infants and Children

Retrieved on: 
Friday, January 6, 2023
Other Health, General Health, Family, Pharmaceutical, Consumer, Infectious Diseases, Parenting, Clinical Trials, Children, Baby, Maternity, Biotechnology, FDA, Health, Streptococcus, Priority review, PDUFA, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Prescription Drug User Fee Act, IPD, Inc., NYSE, Development, Otitis media, PFE, Safety, Streptococcus pneumoniae, FDA, Senior, Vaccine, Pharmaceutical industry, Pfizer

Priority Review designation by the FDA reduces the standard sBLA review period by four months.

Key Points: 
  • Priority Review designation by the FDA reduces the standard sBLA review period by four months.
  • The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the 20vPnC vaccine application is anticipated in April 2023.
  • The FDA previously granted Pfizer’s 20vPnC Fast Track Designation in May 2017 and Breakthrough Therapy Designation in August 2020 for the pediatric indication for IPD.
  • These studies collectively enrolled approximately 3,500 infants and 800 children of all ages.

Vaxcyte Reports Positive Topline Data from Phase 1/2 Proof-of-Concept Study of its 24-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Pneumococcal Disease in Adults Aged 18-64

Retrieved on: 
Monday, October 24, 2022
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-- Vaxcyte to Advance Potential Best-in-Class VAX-24 Clinical Program in Adult and Pediatric Populations --

Key Points: 
  • These four incremental serotypes cover 10-15 percent of strains causing invasive pneumococcal disease (IPD) over the current standard-of-care in adults.
  • We are thrilled with these positive topline results from our Phase 1/2 proof-of-concept study, which met all of our objectives.
  • The study results demonstrate that VAX-24 has the potential to provide broader coverage and better immune responses relative to the standard-of-care.
  • Topline safety, tolerability and immunogenicity data from the infant Phase 2 study primary 3-dose immunization series are expected by 2025.

Medtech Startup NousQ Receives US$175K Grand Prize for Pediatric Ear Tube Insertion Device

Retrieved on: 
Thursday, October 13, 2022
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The winning company was determined by a live audience vote on Sept. 26 during the MedTech Innovator Asia Pacific 2022 Grand Finals hosted by MedTech Innovator in partnership with APACMed.

Key Points: 
  • The winning company was determined by a live audience vote on Sept. 26 during the MedTech Innovator Asia Pacific 2022 Grand Finals hosted by MedTech Innovator in partnership with APACMed.
  • Additionally, NousQ was announced winner of Enterprise Singapores (EnterpriseSG) Startup SG award, comprising an SGD$30,000 grant prize and access to extensive resources and networks within Singapores startup ecosystem.
  • My utmost congratulations to NousQ on winning the APAC MedTech Innovator 2022 title, said Harjit Gill, CEO, APACMed.
  • ErleaDx, Singapore, was announced the winner of the MedTech Innovator Asia Pacific Best Video Award with a US$5,000 prize.

Clarametyx Announces FDA Acceptance of Investigational New Drug (IND) Application for Phase 1 Study of Immune-Enabling Antibody Therapy CMTX-101

Retrieved on: 
Wednesday, October 5, 2022
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(Clarametyx), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.

Key Points: 
  • (Clarametyx), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.
  • Weve made tremendous progress with the early development of this potentially game-changing technology to specifically address bacterial biofilms, which is a major driver of resistance in bacterial infections, said David Richards, Chief Executive Officer, Clarametyx.
  • Collectively, these infections contribute substantial costs to the healthcare system due to significantly increased hospitalization rates and lengths of stay, as well as increased morbidity and mortality.
  • CMTX-101 is intended to be administered concomitantly with a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria.