Meningococcal disease

THE AMERICAN SOCIETY FOR MENINGITIS PREVENTION (ASMP) LAUNCHES TO ADDRESS GROWING NEED FOR MENINGITIS PREVENTION EDUCATION IN THE UNITED STATES

Retrieved on: 
Thursday, March 7, 2024

FARMINGTON HILLS, Mich., March 7, 2024 /PRNewswire/ -- The American Society for Meningitis Prevention (ASMP) launched today to empower Americans to take action to prevent meningococcal meningitis, a life-threatening bacterial infection. Founded by Patti Wukovits and Alicia Stillman, two mothers who tragically lost their daughters to meningococcal meningitis, ASMP aims to raise awareness among adolescents, young adults, parents, healthcare providers, and policymakers about meningococcal meningitis and the critical role of comprehensive vaccination in preventing it.

Key Points: 
  • FARMINGTON HILLS, Mich., March 7, 2024 /PRNewswire/ -- The American Society for Meningitis Prevention (ASMP) launched today to empower Americans to take action to prevent meningococcal meningitis, a life-threatening bacterial infection.
  • To help protect against meningococcal meningitis, patients must be vaccinated against all five types of meningococcal bacteria most likely to cause meningococcal meningitis: A–B–C–W–Y.ii
    "Meningitis prevention education is more important in the U.S. today than ever.
  • Starting today, the American Society for Meningitis Prevention will replace the Meningitis B Action Project.
  • To learn more about the American Society for Meningitis Prevention, visit meningitisprevention.org .

Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Zilbrysq, Zilucoplan, Date of authorisation: 01/12/2023, Status: Authorised

FDA Approves PENBRAYA™, the First and Only Vaccine for the Prevention of the Five Most Common Serogroups Causing Meningococcal Disease in Adolescents

Retrieved on: 
Friday, October 20, 2023

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PENBRAYA™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age.
  • “Today marks an important step forward in the prevention of meningococcal disease in the U.S.
  • The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the U.S. and Europe.
  • The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 25, 2023, to discuss recommendations for the appropriate use of PENBRAYA in adolescents and young adults.

Veopoz™ (pozelimab-bbfg) Receives FDA Approval as the First Treatment for Children and Adults with CHAPLE Disease

Retrieved on: 
Friday, August 18, 2023

TARRYTOWN, N.Y., Aug. 18, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the U.S. Food and Drug Administration (FDA) has approved Veopoz™ (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. Veopoz is the first and only treatment indicated specifically for CHAPLE. With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg BLA have been addressed. FDA action on the aflibercept 8 mg BLA is expected in the next few weeks.

Key Points: 
  • With the approval of Veopoz, the pre-approval inspection issues related to the aflibercept 8 mg BLA have been addressed.
  • FDA action on the aflibercept 8 mg BLA is expected in the next few weeks.
  • Veopoz was reviewed under Priority Review, and the Company received a Rare Pediatric Disease Priority Review voucher upon approval.
  • Veopoz was previously granted Rare Pediatric Disease designation, Orphan Disease designation and Fast Track designation.

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

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.

China Vaccine Market Report 2023 to 2027 - Featuring Walvax Biotechnology, Beijing Tiantan Biological Products, Sinovac Biotech and Shenzhen Kangtai Biological Products Among Others - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 31, 2023

As a result, China has drawn significant attention to the vaccine industry to play a representative role.

Key Points: 
  • As a result, China has drawn significant attention to the vaccine industry to play a representative role.
  • In addition, it is a closed market with a solid local vaccine industry, access to which is challenging for Western players.
  • Meningococcal Meningitis, Pneumococcal, and DTP Vaccine market are expected to control a significant portion of China's vaccine market.
  • The major players covered in the report are Sinopharm Group, Hualan Biological Engineering Inc, Chongqing Zhifei Biological Products Co Ltd, Walvax Biotechnology Co Ltd, Beijing Tiantan Biological Products Corp Ltd, Sinovac Biotech, and Shenzhen Kangtai Biological Products Co Ltd.

U.S. FDA Accepts for Review the Biologics License Application for Pfizer’s Investigational Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents

Retrieved on: 
Wednesday, December 28, 2022

Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine candidate (MenABCWY).

Key Points: 
  • Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for its investigational pentavalent meningococcal vaccine candidate (MenABCWY).
  • Pfizer submitted MenABCWY for the prevention of meningococcal disease caused by the most common serogroups in individuals 10 through 25 years of age.
  • The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the pentavalent meningococcal vaccine application is in October 2023.
  • “We believe our investigational MenABCWY vaccine, if approved and recommended, could help simplify the meningococcal vaccination schedule for adolescents and young adults, and in turn improve vaccination rates, and provide the broadest serogroup coverage of any meningococcal vaccine.

Global Human Vaccines Market Report 2022: Growing Prevalence of Emerging and Re-Emerging Infectious Diseases Fuels Sector - ResearchAndMarkets.com

Retrieved on: 
Wednesday, November 30, 2022

The Global Human Vaccines Market is segmented based on Technology, Type, Disease Indication, End-Users, and Geography.

Key Points: 
  • The Global Human Vaccines Market is segmented based on Technology, Type, Disease Indication, End-Users, and Geography.
  • By Technology, the market is classified into Conjugate Vaccines, Recombinant Vaccines, Inactivated and Subunit Vaccines, Live Attenuated Vaccines, Toxoid Vaccines, and Viral Vector Vaccines.
  • The report presents a detailed Ansoff matrix analysis for the Global Human Vaccines Market.
  • The analyst analyses the Global Human Vaccines Market using the Ansoff Matrix to provide the best approaches a company can take to improve its market position.

Vermont Initiative Gives Clinicians New Tools for Infectious Disease Diagnosis and Response

Retrieved on: 
Thursday, November 3, 2022

The Vermont Department of Health has launched a first-of-a-kind program to support healthcare professionals with timely information on disease diagnosis, testing, treatment and patient education resources improving public health response statewide.

Key Points: 
  • The Vermont Department of Health has launched a first-of-a-kind program to support healthcare professionals with timely information on disease diagnosis, testing, treatment and patient education resources improving public health response statewide.
  • The Clinician Support Initiative provides access to a vast collection of images and clinical information about public health threats, including hMPXV (human monkeypox virus), COVID-19 and Lyme disease.
  • These resources are being made available to Vermont healthcare professionals in partnership with VisualDx , a healthcare informatics company based in Rochester, NY.
  • A phased rollout is currently underway, and all Vermont medical professionals can expect access by the end of the year.

Global Meningococcal Vaccines Market 2022: Increasing Prevalence of the Meningococcal Disease in Children Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Monday, September 26, 2022

The "Meningococcal Vaccines Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Meningococcal Vaccines Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.
  • The global meningococcal vaccines market size reached US$ 3.0 Billion in 2021.
  • The three main kinds of meningococcal vaccines include conjugate, polysaccharide and subcapsular meningococcal vaccines.
  • The increasing prevalence of the meningococcal disease among young children and adolescents across the globe represents one of the key factors driving the growth of the market.