Streptococcus

Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults

Retrieved on: 
Monday, April 29, 2024

The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.

Key Points: 
  • The trial evaluated the immunogenicity, tolerability and safety of V116 compared to PPSV23 (pneumococcal vaccine, polyvalent [23-valent]) in adults 50 years of age and older who had not previously received a pneumococcal vaccine.
  • V116 is currently under review by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
  • The FDA granted V116 priority review with a Prescription Drug User Fee Act (PDUFA), or target action date, of June 17, 2024.
  • V116 is specifically designed to help protect adults from invasive pneumococcal disease; the serotypes in V116 account for approximately 83% of adult invasive pneumococcal disease in individuals 65 and older, according to U.S. Centers for Disease Control and Prevention data from 2018-2021.

The Office of Health Economics: Adult Vaccination Programmes Deliver Socio-economic Benefits up to 19 Times Initial Investment, According to New Report

Retrieved on: 
Thursday, April 18, 2024

A new report published today reveals that adult vaccination programmes can return up to 19 times their initial investment when the full spectrum of economic and societal benefits is valued.

Key Points: 
  • A new report published today reveals that adult vaccination programmes can return up to 19 times their initial investment when the full spectrum of economic and societal benefits is valued.
  • View the full release here: https://www.businesswire.com/news/home/20240417519822/en/
    Learn more about the economic benefits of investing in adult immunisation programmes in a new study by the Office of Health Economics (OHE).
  • The report concludes that the vaccination programmes deliver substantial returns on government investment through cost savings within healthcare systems and wider socio-economic benefits.
  • “Our findings show that costs are offset multiple times over by benefits to society when governments invest in adult immunisation programmes.

Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults

Retrieved on: 
Tuesday, March 19, 2024

V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.

Key Points: 
  • V116 also elicited higher immune responses than the studied comparators for the serotypes unique to V116 in all STRIDE studies presented at the meeting.
  • If approved, V116 would be the first pneumococcal conjugate vaccine specifically designed for adults.
  • Participants were enrolled based on previous pneumococcal vaccination with PPSV23, PCV15, PCV13 (pneumococcal 13-valent conjugate vaccine), PPSV23+PCV13, PCV13+PPSV23 or PCV15+PPSV23, and received either V116, PCV15 or PPSV23.
  • V116 elicited comparable immune responses to the comparator, PCV15+PPSV23, for all 13 shared serotypes and higher immune responses for the eight serotypes covered only by V116.

European Commission Approves Pfizer’s PREVENAR 20® to Help Protect Infants and Children Against Pneumococcal Disease

Retrieved on: 
Wednesday, March 13, 2024

“The EC’s authorization of PREVENAR 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer.

Key Points: 
  • “The EC’s authorization of PREVENAR 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer.
  • The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein and Norway.
  • Regulatory applications for PREVENAR 20 for the pediatric indication have been submitted to additional countries around the world.
  • These studies collectively enrolled more than 4,700 infants and 800 toddlers and children of all ages.

Cepheid Receives FDA Clearance for Xpert® Xpress GBS

Retrieved on: 
Monday, March 11, 2024

SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS). This next-generation test incorporates new dual targets in highly-conserved regions of the GBS genome to improve sensitivity and bacterial strain coverage. The test is designed for use on Cepheid's GeneXpert® systems.

Key Points: 
  • SUNNYVALE, Calif., March 11, 2024 /PRNewswire/ -- Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration for Xpert® Xpress GBS, a dual-target molecular diagnostic test for the qualitative intrapartum detection of Group B Streptococcus (GBS).
  • Xpert Xpress GBS allows for the use of intrapartum direct PCR testing for women with unknown or unavailable antepartum GBS status.
  • With the capability of returning positive results as early as 30 minutes,2 Xpert Xpress GBS can provide real-time GBS status and inform decisions about empiric antibiotic prophylaxis if appropriate, to prevent GBS transmission during birth.
  • With Xpert Xpress GBS, Cepheid continues to provide fast, accurate, and reliable PCR solutions to facilitate evidence-based treatment and improved clinical care.

TikTok claims ‘tongue scrapers’ can cure bad breath – here’s what the evidence actually says

Retrieved on: 
Wednesday, March 13, 2024

Tongue scraping has long been part of daily hygiene routines in many parts of the world.

Key Points: 
  • Tongue scraping has long been part of daily hygiene routines in many parts of the world.
  • But while there’s some evidence to back these claims, the practise could also come with risks.
  • Poor oral health can lead to a build-up of biofilms containing certain bacterial species which cause dental decay (cavities), gum disease and bad breath.
  • But there’s less evidence showing whether these techniques are also effective for preventing tongue biofilms and bad breath.

Tongue scraping

  • However, these reviews did find that the benefits of tongue scraping were shortlived and needed to be done using a specific technique to be effective.
  • There are other caveats when it comes to tongue scraping.
  • In these instances, tongue scraping will do little to solve bad breath.
  • One study has suggested that tongue scraping may actually enrich the amount of nitrate-reducing bacteria on the tongue.
  • It will be important for further research to be done with more participants to better determine both the potential benefits and harms of tongue scraping.

Should I use a tongue scraper?

  • It’s also likely that the benefits and downsides of using a tongue scraper would differ for each person.
  • Good oral hygiene will probably be enough to fix bad breath – and aggressive tongue scraping may actually risk making your tongue bleed.
  • We also don’t yet fully know how tongue scraping will affect good bacteria on you tongue.
  • Scrape your tongue, or clean your tongue with a toothbrush, with care, if you must.


Zoe Brookes does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

IDFA Relaunches Live and Active Cultures Seal for Yogurt and Cultured Dairy Product Makers to Showcase Benefits of Gut Health

Retrieved on: 
Thursday, March 7, 2024

WASHINGTON, March 07, 2024 (GLOBE NEWSWIRE) -- To help consumers better identify yogurt, frozen yogurt, and other cultured dairy products containing live and active yogurt cultures, the International Dairy Foods Association (IDFA) is relaunching its Live & Active Cultures (LAC) Seal for manufacturers.

Key Points: 
  • WASHINGTON, March 07, 2024 (GLOBE NEWSWIRE) -- To help consumers better identify yogurt, frozen yogurt, and other cultured dairy products containing live and active yogurt cultures, the International Dairy Foods Association (IDFA) is relaunching its Live & Active Cultures (LAC) Seal for manufacturers.
  • IDFA’s LAC Seal is the only widely recognized, independent verification that a dairy product contains significant levels of live and active yogurt cultures.
  • When it comes to yogurt and similar cultured dairy products, the words "live and active cultures" are persuasive.
  • Gut health and nutrition rank among the top drivers for consumers who purchase yogurt and similar cultured dairy products.

Ligand Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024

Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.

Key Points: 
  • Royalties for the fourth quarter of 2023 were $22.5 million, compared with $22.0 million for the same period in 2022.
  • Costs of Captisol sales were $1.6 million for the fourth quarter of 2023, compared with $21.6 million for the same period in 2022, with the decrease due to lower total Captisol sales during the fourth quarter of 2023 and $9.8 million in accelerated depreciation on Captisol manufacturing equipment during the fourth quarter of 2022.
  • Amortization of intangibles was $8.3 million for the fourth quarter of 2023, compared with $8.5 million for the same period in 2022.
  • Travere also announced fourth quarter 2023 results reporting that it received 459 new patient start forms for FILSPARI in the fourth quarter of 2023 and net product sales of $14.9 million for the fourth quarter.

Medicines360 and DKT WomanCare Announce Strategic Partnership to Expand Access to the Hormonal IUD Avibela™

Retrieved on: 
Wednesday, January 31, 2024

"As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.

Key Points: 
  • "As a global nonprofit pharmaceutical organization dedicated to expanding access to affordable reproductive health products for women, DKT WomanCare is an ideal partner for our organization," said Dr. Andrea Olariu, CEO of Medicines360.
  • “DKT WomanCare looks forward to leveraging our global partnerships and commercial relationships to ensure every woman, regardless of income, can access affordable, high-quality contraception.
  • As the supplier of AVIBELA, Medicines360 will focus on providing quality assurance and regulatory oversight, as well as ensuring sustainable product supply to DKT WomanCare and global procurement agencies.
  • Together, Medicines360 and DKT WomanCare will meet the growing demand for quality-assured, affordable hormonal IUDs and help build a robust and sustainable global contraceptive market.

Summary of opinion: Apexxnar, 25/01/2024 Positive

Retrieved on: 
Sunday, February 4, 2024

On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prevenar 20.

Key Points: 
  • On 25 January 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Prevenar 20.
  • The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.
  • The CHMP adopted an extension to the existing indication for prophylaxis against pneumonia and acute otitis media caused by pneumococci and associated invasive disease, in infants, children and adolescents.
  • Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.