National Agency for Food and Drug Administration and Control

PHAXIAM Therapeutics obtains authorizations to launch its phase 1 study in endocarditis infections caused by Staphylococcus aureus

Retrieved on: 
화요일, 10월 24, 2023

Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria.

Key Points: 
  • Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria.
  • The main cause of endocarditis infections, S. aureus, is responsible for around 30%1 of cases.
  • Pascal Birman, Chief Medical Officer of PHAXIAM Therapeutics, stated: "This phase 1 study was designed primarily to assess the safety and pharmacokinetics of our anti-S. aureus phages in the treatment of endocarditis infections.
  • The treatment of endocarditis infections caused by S. aureus using phage therapy could thus offer a major alternative and hope to many patients who have reached a therapeutic impasse.”

From pests to pollutants, keeping schools healthy and clean is no simple task

Retrieved on: 
금요일, 9월 29, 2023

But a research collaborative, of which I’m a member, has found that schools might not be ready to protect students from environmental contaminants.

Key Points: 
  • But a research collaborative, of which I’m a member, has found that schools might not be ready to protect students from environmental contaminants.
  • Environmental health standards can help a school community ensure each potential hazard is accounted for.

Air, water and food quality

    • Understanding and controlling common pollutants indoors can improve the indoor air quality and reduce the risk of health concerns.
    • It may seem like maintaining proper food safety and drinking-water quality would be common practices.
    • But many schools do have some level of lead contamination in their food and water.
    • To combat contamination and ensure safe food and water, the Food and Drug Administration overhauled the Food Safety Modernization Act in 2016.

Integrated pest management

    • Many schools have insect infestations, and many combat these pest problems with harsh chemicals when there’s a simpler solution.
    • Integrated pest management is an environmentally sensitive approach to pest management.
    • IPM programs consider the pests’ life cycles and their larger environment, as well as all the available pest control methods, to manage pest infestations economically and scientifically.

Green cleaning

    • School administrators also determine what products to use for pest control and cleaning.
    • Green cleaning uses safer – or less harsh – chemical and pesticide products, since studies have found that the repeated use of harsh chemicals indoors can lead to chronic health effects later in life for anyone directly exposed.
    • Schools need a plan to manage their pollutants long term – these pollutants might be cleaning chemicals and pesticides or chemicals used in science classes.
    • When the school building is safe, students and educators are more able to get down to the business of learning, undistracted.

Crossject reports successful completion of European and U.S. audits for manufacturing of ZENEO® Midazolam for epileptic seizures

Retrieved on: 
화요일, 9월 5, 2023

‘‘These positive reports from both sides of the Atlantic are an important demonstration of Crossject’s stringent manufacturing and quality systems standards.

Key Points: 
  • ‘‘These positive reports from both sides of the Atlantic are an important demonstration of Crossject’s stringent manufacturing and quality systems standards.
  • These are essential for Crossject to ensure quality and bring our products to market in Europe and the United States,” said Patrick Alexandre, CEO of Crossject.
  • “ZENEO® Midazolam will provide a new, simple and reliable method of administering emergency treatment of status epilepticus seizures, delivering life-saving medicine rapidly and accurately.
  • Crossject Dijon and Gray sites met all the requirements for manufacturing and control of its auto-injector device under Quality Systems and CGMPs.

Rhythm Pharmaceuticals Announces Pre-Marketing Early Access Authorization for Setmelanotide for Use in Patients with Hypothalamic Obesity in France

Retrieved on: 
월요일, 8월 7, 2023

BOSTON, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with hyperphagia and severe obesity caused by rare melanocortin-4 receptor (MC4R) pathway diseases, today announced that the French National Agency for Medicines and Health Products Safety (ANSM) and French National Authority for Health (HAS) have granted pre-marketing early access authorization AP1 (Autorisation d’Accès Précoce), for IMCIVREE® (setmelanotide), an MC4R agonist, for patients with lesional hypothalamic obesity.

Key Points: 
  • Setmelanotide has been available through a similar program for patients in France with Bardet-Biedl syndrome (BBS) since July 2022.
  • Rhythm estimates there are approximately 500-2,000 patients living with hypothalamic obesity in France, with approximately 50 to 200 new cases each year.
  • In the United States, the Company estimates the prevalence in hypothalamic obesity to be approximately 5,000-10,000 patients with an annual incidence of approximately 500 new patients.
  • “This AP1 addresses a significant unmet need for patients with severe obesity and hyperphagia, two hallmark symptoms of hypothalamic obesity, for the first time.”

The 2021 & 2022 Impact Report for Fungi Perfecti®

Retrieved on: 
목요일, 8월 3, 2023

OLYMPIA, Wash., Aug. 3, 2023 /PRNewswire/ -- Fungi Perfecti, LLC has released their very first Impact Report , covering their combined efforts towards greater sustainability, transparency, and corporate responsibility throughout 2021 and 2022.

Key Points: 
  • OLYMPIA, Wash., Aug. 3, 2023 /PRNewswire/ -- Fungi Perfecti, LLC has released their very first Impact Report , covering their combined efforts towards greater sustainability, transparency, and corporate responsibility throughout 2021 and 2022.
  • Fungi Perfecti offsets the combined total of their scopes 1, 2 & 3 emissions by 110% - making them climate positive!
  • In an exciting shift, Fungi Perfecti has also begun calculating and offsetting scope 3 emissions.
  • * Fungi Perfecti is a Certified B Corporation and is third-party designated as Climate Positive, offsetting 110% of their carbon emissions.

Pesticides are harming Nigeria: it’s time to update the law

Retrieved on: 
목요일, 7월 27, 2023

This is because of their potential health effects or environmental contamination, or because there’s not enough data to be sure that they aren’t harmful.

Key Points: 
  • This is because of their potential health effects or environmental contamination, or because there’s not enough data to be sure that they aren’t harmful.
  • Nigeria’s use of such pesticides is the reason some markets, including the EU and the US, reject the country’s agricultural products.
  • Yet some countries with strict regulations at home still export the banned pesticides to countries like Nigeria.

Limiting factors

    • There are no provisions to hold manufacturers accountable for the negative impact of hazardous pesticides.
    • No law requires people to use personal protective equipment when applying pesticides.
    • For instance, the proposed bill to establish a pesticides council reserves two seats for an internationally affiliated association, CropLife Nigeria.
    • Instead, the council should consist of neutral and independent organisations from the scientific and academic communities.

Why effective regulation matters

    • Seventy-five percent of the women farmers in the survey reported symptoms from using pesticides.
    • Without strict regulation and enforcement, farmers might misuse or overuse pesticides in farms and storerooms.
    • Weak regulations also make Nigeria vulnerable to becoming a dumping ground for internationally banned and counterfeit pesticides.

What needs to be done

    • They have passed laws that prohibit pesticides that are banned in the countries that make or export them.
    • The legal community should engage in public interest litigation to hold manufacturing companies accountable for harm caused by pesticides.
    • Ofoegbu Donald Ikenna, senior programme manager, Sustainable Nigeria programme, Heinrich Boell Stiftung (hbs) Nigeria office, contributed to this article.

UroMems Announces First-Ever Smart Artificial Urinary Sphincter Implant in a Female Patient

Retrieved on: 
목요일, 7월 20, 2023

GRENOBLE, France and MINNEAPOLIS, July 20, 2023 /PRNewswire/ -- UroMems, a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive™ smart, automated artificial urinary sphincter (AUS) in a female patient. This milestone indicates a new era for millions of women suffering from SUI, and results of this clinical study will contribute to the design and implementation of UroMems' pivotal clinical trial in Europe and the U.S.

Key Points: 
  • Initial clinical study results will inform pivotal clinical trial in U.S. and Europe
    GRENOBLE, France and MINNEAPOLIS, July 20, 2023 /PRNewswire/ -- UroMems , a global company developing innovative, mechatronics technology to treat stress urinary incontinence (SUI), announced today that it has successfully completed the first-ever implant of the UroActive™ smart, automated artificial urinary sphincter (AUS) in a female patient.
  • "We are addressing the observations by so many physicians that there is a vast unmet need for a better way to definitively treat this female population."
  • UroActive is the first smart active implant that treats SUI, powered by a MyoElectroMechanical System (MEMS).
  • While mild SUI is addressed by pelvic floor re-education and bulking agents, moderate and severe SUI historically have only had two options: mesh sling or manually-operated artificial urinary sphincter.

Kudelski Group Expands Quantum Security Solutions to Address Advanced and Evolving Threat Landscape

Retrieved on: 
토요일, 6월 10, 2023

Most experts predict that quantum computers with the maturity to break existing cryptographic techniques will be available in less than a decade.

Key Points: 
  • Most experts predict that quantum computers with the maturity to break existing cryptographic techniques will be available in less than a decade.
  • To address this rapidly escalating quantum threat, the Kudelski Group, along with its partners, is providing clients with a suite of services and products designed to streamline and expedite this shift to quantum-resistant technologies.
  • This comprehensive strategy incorporates a thorough quantum threat evaluation, a detailed cryptographic discovery and inventory process, and a review of the client's existing security architecture.
  • Kudelski is leading the market in the quantum transition, leveraging proven expertise and experience in quantum security and cryptograhy to help strengthen controls and harden devices, systems and data against the advanced attacks of the future.

CATIC Announces New National Agency Division

Retrieved on: 
수요일, 5월 17, 2023

ROCKY HILL, Conn., May 17, 2023 /PRNewswire/ -- CATIC is pleased to announce the formation of its National Agency Division.

Key Points: 
  • ROCKY HILL, Conn., May 17, 2023 /PRNewswire/ -- CATIC is pleased to announce the formation of its National Agency Division.
  • The Division will include Kyle Rank, Senior Vice President, National Accounts Manager who joined CATIC in January of this year.
  • Joining Kyle will be Christine Huff, Vice President, National Agency Manager, Anthony Nalbone, Vice President, National Agency Manager, and Bart Bodkin, Vice President, National Underwriting Counsel.
  • She brings with her a broad range of knowledge and experience having worked in multiple departments and roles throughout her lengthy career, including the title plant, accounting, legal/underwriting, national agency administration, and national agency sales.

Nigeria has Africa's highest malaria death rate - progress is being made, but it's not enough

Retrieved on: 
월요일, 4월 24, 2023

In 2021, for instance, around 247 million cases of malaria were reported and about 619,000 people died.

Key Points: 
  • In 2021, for instance, around 247 million cases of malaria were reported and about 619,000 people died.
  • He’s also the former technical director to the National Malaria Elimination Programme in Nigeria.
  • The existence of malaria anywhere is an interaction between the environment and the organism responsible for the disease.
  • When you look at an environment, you’re looking at natural factors such as the temperature and humidity.
  • In terms of humidity, Nigeria has a vegetation that favours the reproductive stages of the parasite in the mosquito which serves as a vector.
  • It’s only the Mambilla Plateau, in Taraba State, northeastern Nigeria, that’s considered relatively malaria free in Nigeria.
  • The Nigerian National Agency for Food and Drug Administration And Control recently approved the R21 malaria vaccine for use.
  • Let the manufacturers take over distribution using their own market principles in a manner that will be affordable to many people.
  • We need to look at new initiatives and also position ourselves in the vaccine game with respect to malaria.