Serotype

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
Research, Family, Pharmaceutical, Consumer, Infectious Diseases, Parenting, Clinical Trials, Science, Children, Baby, Maternity, Biotechnology, FDA, Health, Safety, PDUFA, PFE, CDC, Global health, Senior, RSV, NYSE, Biologics license application, Streptococcus, Meningococcal disease, European Medicines Agency, BLA, Pregnancy, Respiratory syncytial virus, Serotype, Regulation of tobacco by the U.S. Food and Drug Administration, ACIP, Infant, Infection, Streptococcus pneumoniae, Inc., Otitis media, EMA, Immunization, Conference, MAA, Hospital, Woman, Food, IPD, Pharmaceutical industry, Vaccine, Pfizer

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 Review the Biologics License Application for Pfizer’s Investigational Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents

Retrieved on: 
Wednesday, December 28, 2022
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Meningococcal disease, PDUFA, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Prescription Drug User Fee Act, Vaccination, BLA, Death, Naphthoate synthase, Inc., Disease, Patient, Mortality, NYSE, Serotype, Development, IMD, PFE, ACIP, Survivor, Safety, FDA, Vaccine, Senior, Biologics license application, Inactivated vaccine, Pharmaceutical industry, Pfizer

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.

Clear Labs to Present at IAFP Annual Meeting of 4,000 Global Food Safety Experts

Retrieved on: 
Wednesday, July 27, 2022
Clear Labs, DNA, Whole genome sequencing, NGS, International Association for Food Protection, Genomics, SAN, Annual general meeting, Culture, IAFP, Serotype, Infection, Method, Robotics, International Association, Labs, Food safety, PCR, Vaccine, Salmonella

SAN CARLOS, Calif., July 27, 2022 /PRNewswire-PRWeb/ -- This week, Clear Labs, the leader in fully automated, next-generation sequencing (NGS) for turnkey genomic surveillance and diagnostics, is attending and presenting at the International Association for Food Protection (IAFP) 2022 Annual Meeting. As a renowned worldwide food safety conference, the IAFP Annual Meeting educates attendees on current and emerging food safety issues, as well as the latest innovative solutions to new and recurring problems. The meeting also provides an opportunity to network with nearly 4,000 top food safety professionals from six continents.

Key Points: 
  • As a renowned worldwide food safety conference, the IAFP Annual Meeting educates attendees on current and emerging food safety issues, as well as the latest innovative solutions to new and recurring problems.
  • The meeting also provides an opportunity to network with nearly 4,000 top food safety professionals from six continents.
  • Clear Labs Staff Scientist Andrew Lin is among notable guests leading more than 100 sessions ranging from cultivating diversity in food safety spaces to innovative ways for improving the detection and serotyping of Salmonella.
  • Clear Labs is widely recognized as a pioneer in food safety.

Outlook on the Meningococcal Vaccines Global Market to 2030 - Increasing Immunization Programs and Government Initiatives is Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 14, 2022
Infectious Diseases, Pharmaceutical, Health, Inactivated vaccine, Sanofi, Goal, NIP, ECDC, Meningitis Vaccine Project, Disease, Government, National Center for Immunization and Respiratory Diseases, Organization, WHO, Meningitis, MenAfriVac, Vaccine, FDA, Growth, Profile, Meningococcal disease, Incidence, Prevalence, Epidemic, CAGR, USD, Pharmaceutical industry, Meningococcal vaccine, Meningococcal vaccine, Serotype, EU, Meningococcal vaccine

The global meningococcal vaccines market size is expected to reach USD 4.92 billion by 2030, registering a CAGR of 6.2%.

Key Points: 
  • The global meningococcal vaccines market size is expected to reach USD 4.92 billion by 2030, registering a CAGR of 6.2%.
  • In addition, rising FDA approval for meningococcal vaccines is expected to boost the growth.
  • The increase in approval of novel vaccines is expected to improve meningococcal prevention which in turn, is anticipated to drive the market.
  • Initiatives undertaken by the government to combat the rising incidence of the disease are anticipated to boost the meningococcal vaccine market growth.

Clear Labs Automated NGS Technology Platform (Clear Safety™) Approved by USDA's National Poultry Improvement Plan for Salmonella Detection

Retrieved on: 
Thursday, October 14, 2021
Turkey, National Poultry Show, United States Department of Agriculture, Food, Mycoplasma gallisepticum, Animal and Plant Health Inspection Service, Clear Labs, Accreditation, Program, Severe acute respiratory syndrome coronavirus 2, Freedom, Root cause analysis, Pullorum disease, Serotype, APHIS, Safety, Federal, Industry, Mycoplasma meleagridis, Mortality, Infection, Salmonella enterica subsp. enterica, Mycoplasma synoviae, State, Health, DNA, PCR, Labs, NGS, SAN, USDA, Poultry disease, Poultry, Food safety, Genomics, Partnership, Robotics

SAN CARLOS, Calif., Oct. 14, 2021 /PRNewswire-PRWeb/ -- Today, Clear Labs , a leader in providing fully automated, next-generation sequencing (NGS) platforms for turnkey diagnostics, is announcing that Clear Safety Salmonella has been approved by the National Poultry Improvement Plan (NPIP) for interim use in the detection of Salmonella.

Key Points: 
  • SAN CARLOS, Calif., Oct. 14, 2021 /PRNewswire-PRWeb/ -- Today, Clear Labs , a leader in providing fully automated, next-generation sequencing (NGS) platforms for turnkey diagnostics, is announcing that Clear Safety Salmonella has been approved by the National Poultry Improvement Plan (NPIP) for interim use in the detection of Salmonella.
  • "The approval from NPIP is a big validation for the power and promise of our platform that focuses on timely detection providing deeper insights.
  • Clear Labs is widely recognized as a pioneer in fully automated NGS-based food safety for Salmonella and Listeria detection.
  • Clear Labs helps companies gain greater operational awareness and leverages its turnkey NGS food safety testing platform to protect brands and ensure consumer safety.

Clear Labs Announces Salmonella Serotyping Capabilities Powered by Next-Generation Sequencing (NGS)

Retrieved on: 
Tuesday, February 19, 2019
Biology, Branches of biology, Clear Labs, DNA sequencing, Serotype, Life sciences

MENLO PARK, Calif., Feb. 19, 2019 /PRNewswire-PRWeb/ -- Clear Labs , the only automated and intelligent NGS platform purpose-built for food safety testing, today announced new serotyping capabilities on its Clear Safety platform.

Key Points: 
  • MENLO PARK, Calif., Feb. 19, 2019 /PRNewswire-PRWeb/ -- Clear Labs , the only automated and intelligent NGS platform purpose-built for food safety testing, today announced new serotyping capabilities on its Clear Safety platform.
  • Clear Safety's new serotyping capabilities will give food safety professionals more information than ever before.
  • Cost Effective: With Clear Safety, Salmonella screening and serotyping are conducted at the same time, using the same assays, media, and consumables.
  • In addition to Clear Safety, Clear Labs' platform supports testing for authenticity, GMO, and microbiome testing.