Bureau of Oceans and International Environmental and Scientific Affairs

LumiraDx Partners with AstraZeneca & Everton in the Community to Set Up England’s First Heart & Lung Screening Hub

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金曜日, 10月 20, 2023

The LumiraDx NT-proBNP test is the only NT-proBNP test currently available that can be used with a simple fingerstick sample.

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The LumiraDx NT-proBNP test is the only NT-proBNP test currently available that can be used with a simple fingerstick sample.
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LONDON, Oct. 20, 2023 (GLOBE NEWSWIRE) -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, is pleased to announce a strategic collaboration with AstraZeneca and Everton in the Community to set up England’s first community-based heart and lung screening hub, set to go live in November.
The official charity of Everton Football Club will run this novel screening hub from the recently opened People’s Place.
The strategic partnership with AstraZeneca and Everton in the Community will also work closely with Liverpool University Hospitals NHS Foundation Trust and next generation medical technology providers Lenus Health, Us2.ai and ArtiQ.

Empaveli is the first treatment for PNH that binds to the complement protein C3.

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火曜日, 10月 17, 2023

Biotechnology, General Health, Pharmaceutical, Health, ANVISA, Partnership, Bureau of Oceans and International Environmental and Scientific Affairs, Multimedia, Brazilian Health Regulatory Agency, Pharma, Paroxysmal nocturnal hemoglobinuria, PNH, System, Rare, Hematology, Patient, Quality of life, Hemolysis, Pharmaceutical industry

Pint Pharma and OrphanDC announced on July 25th that ANVISA, the National Health Surveillance Agency, approved, on July 25th, 2023, the drug EMPAVELI® (pegcetacoplan, indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)).

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Pint Pharma and OrphanDC announced on July 25th that ANVISA, the National Health Surveillance Agency, approved, on July 25th, 2023, the drug EMPAVELI® (pegcetacoplan, indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH)).
Empaveli is the first treatment for PNH that binds to the complement protein C3.
View the full release here: https://www.businesswire.com/news/home/20231017388408/en/
ANVISA, Brazilian National Health Surveillance Agency, approves EMPAVELI® medication for the treatment of PNH (Photo: Business Wire)
PNH is a rare, chronic, and life-threatening blood disease in which uncontrolled complement activation leads to the destruction of red blood cells through intravascular hemolysis and extravascular hemolysis.
“The approval of Empaveli by ANVISA is a milestone for people living with PNH in Brazil, as PNH symptoms can significantly affect patients' quality of life,” said David Munoz, CEO and president of Pint Pharma.

LIXTE Biotechnology Holdings Announces the Passing of its Founder, John S. Kovach

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月曜日, 10月 9, 2023

(“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage biotechnology company developing a novel class of cancer therapy called PP2A inhibitors, today announced the passing of its founder and Executive Chairman, John S. Kovach, M.D.

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(“LIXTE” or the “Company”) (Nasdaq: LIXT and LIXTW), a clinical stage biotechnology company developing a novel class of cancer therapy called PP2A inhibitors, today announced the passing of its founder and Executive Chairman, John S. Kovach, M.D.
Dr. Kovach, 87, founded the Company in 2005 and held a distinguished medical and scientific career that focused on the causation and treatment of cancer.
Dr. Kovach served as LIXTE’s President and Chief Executive Officer from 2005 through September 26, 2023.
In connection with the Company’s management succession plan, Dr. Kovach was succeeded as President and Chief Executive Officer by Bas van der Baan on that date.

Qihui “Jim” Zhai, MD, FCAP, elected President-Elect of the College of American Pathologists

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土曜日, 10月 7, 2023

Qihui “Jim” Zhai, MD, FCAP, is the newly elected President-elect of the College of American Pathologists (CAP).

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Qihui “Jim” Zhai, MD, FCAP, is the newly elected President-elect of the College of American Pathologists (CAP).
Dr. Zhai was inaugurated at a meeting of the membership on Saturday, October 7, 2023.
“In 1993, I arrived in the U.S. with dreams of freedom, opportunities, and the pursuit of excellence,” Dr. Zhai said.
“I consider myself incredibly fortunate as I am living the American dream, and the CAP has played a pivotal role in my life and career.

Drug Labeling Studies in Clinical Pharmacology: Recent FDA/EMA Updates, Upcoming Webinar Hosted by Xtalks

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火曜日, 10月 10, 2023

TORONTO, Oct. 10, 2023 /PRNewswire-PRWeb/ -- During clinical development, new drug candidates undergo a series of key studies aiming to establish optimal treatment doses and dosing regimens and to confirm drug efficacy. Accompanying these principle clinical trials, a variety of ancillary studies — often referred to as drug labeling or new drug application (NDA) enabling studies — need to be conducted to complete a drug's filing dossier as a prerequisite for initiating the drug approval process. Common examples of drug labeling studies are: food effect studies, drug-drug interaction (DDI) studies, cardiac safety (QTc assessment or thorough QT [TQT]) studies, absorption-distribution-metabolism-excretion (ADME) studies, ethnic bridging studies and studies in special populations such as renally or hepatically impaired patients, elderly and postmenopausal subjects.

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In this free webinar, gain insights into the latest guidelines from the FDA and EMA on drug labeling in clinical pharmacology.
Accompanying these principle clinical trials, a variety of ancillary studies — often referred to as drug labeling or new drug application (NDA) enabling studies — need to be conducted to complete a drug's filing dossier as a prerequisite for initiating the drug approval process.
Common examples of drug labeling studies are: food effect studies, drug-drug interaction (DDI) studies, cardiac safety (QTc assessment or thorough QT [TQT]) studies, absorption-distribution-metabolism-excretion (ADME) studies, ethnic bridging studies and studies in special populations such as renally or hepatically impaired patients, elderly and postmenopausal subjects.
Join this webinar to gain insights into the latest guidelines from the FDA and EMA on drug labeling in clinical pharmacology.

Takeda Launches New App to Help Healthcare Professionals Keep Pace with Important Clinical Trial Data

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火曜日, 10月 3, 2023

TORONTO, Oct. 3, 2023 /CNW/ - Today, Takeda Canada Inc. ("Takeda") announced the launch of Clinical Trials (CT) Lexicon, an innovative app that provides healthcare professionals with a centralized library of key studies and data at their fingertips.

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TORONTO, Oct. 3, 2023 /CNW/ - Today, Takeda Canada Inc. ("Takeda") announced the launch of Clinical Trials (CT) Lexicon, an innovative app that provides healthcare professionals with a centralized library of key studies and data at their fingertips.
The initial launch of the app focuses on Inflammatory Bowel Disease (IBD) with additional clinical focus areas to be rolled-out at later stages.
Last year, Takeda founded the first $1 Million Pioneer Grant through the Canadian IBD Research Consortium (CIRC) in support of high-quality, impactful Canadian clinical research.
This year, Takeda helped establish Canadian IBD Today, to help ensure Canadian physicians can share real-world experiences in a Canadian setting with Canadian patients.

Dario Publishes New Research Demonstrating Clinically Significant Reductions in Depression Through its Digital Behavioral Health Programs

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水曜日, 9月 27, 2023

NEW YORK, Sept. 27, 2023 /PRNewswire/ -- DarioHealth Corp. (Nasdaq: DRIO) ("Dario" or the "Company"), a leader in the global digital health market, announced new research published in the Journal of Medical Internet Research (JMIR) demonstrating the impact of coaching and breathing exercises as part of the Dario digital behavioral health program alongside coaching and breathing exercises for members living with depression or anxiety.

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Dario's behavioral health solution uses an evidence-based triage screener to assess individual mental health needs and recommend the right type of care for each person.
Dario's digital Cognitive Behavioral Therapy (CBT) based programs offer members self-guided programs designed to teach proven techniques for managing emotional health.
The study analyzed the data of participants in two cohorts engaged in Dario's digital self-guided programs who started at a moderate or high level of depression or anxiety.
"Digital health solutions, particularly in behavioral health, have tremendous potential to help people access support when and how they need it.

Colgate Bright Smiles, Bright Futures® Teams up With U.S. Soccer Foundation’s “Soccer for Success Program” to Teach Habits That Improve Health Outcomes

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月曜日, 9月 25, 2023

Today the Colgate Bright Smiles, Bright Futures (BSBF) oral health education initiative announced that it is teaming up with the U.S. Soccer Foundation’s Soccer for Success program for a partnership focused on the links between oral health and overall health and wellbeing.

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Today the Colgate Bright Smiles, Bright Futures (BSBF) oral health education initiative announced that it is teaming up with the U.S. Soccer Foundation’s Soccer for Success program for a partnership focused on the links between oral health and overall health and wellbeing.
The initiative will provide children with information and tools to help improve their oral health and overall health and wellbeing, while enhancing their soccer skills.
As part of the Colgate BSBF and Soccer for Success partnership, trained coach-mentors will lead youth in soccer drills embedded with nutrition, physical activity, youth development – and, importantly, oral health lessons.
Families and coach-mentors will also receive resources to help build healthy oral health and hygiene habits at home.

Modern Health Expands Substance Use Care Offering To Address Ongoing Substance Use Crisis

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木曜日, 9月 21, 2023

Modern Health , a leading global workplace mental health platform, today during National Recovery Month , announces the expansion of its substance use care offering, providing robust and comprehensive support for employers and their employees with substance use concerns.

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Modern Health , a leading global workplace mental health platform, today during National Recovery Month , announces the expansion of its substance use care offering, providing robust and comprehensive support for employers and their employees with substance use concerns.
Modern Health is empowering employers to support their entire workforce with clinically robust and personalized care no matter where they are in their journey.
Despite these alarming numbers, the vast majority—more than four out of five Americans who need treatment for substance use—do not receive it.
“Drug and alcohol misuse frequently co-occur with mental health concerns, so comprehensive healthcare has to include whole-person care that addresses employees’ mental and behavioral health, not just their physical health needs.

American Chemistry Council (ACC): Let Chemistry Create, so America Can Compete

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水曜日, 9月 20, 2023

WASHINGTON, Sept. 20, 2023 /PRNewswire/ -- The American Chemistry Council (ACC) is urgently calling on the Biden Administration and Congress to reverse the growing trend of regulatory overreach. Today it launched "Chemistry Creates, America Competes" to help the Biden Administration and Congress understand that American success relies on American Chemistry.

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WASHINGTON, Sept. 20, 2023 /PRNewswire/ -- The American Chemistry Council (ACC) is urgently calling on the Biden Administration and Congress to reverse the growing trend of regulatory overreach.
Today it launched " Chemistry Creates, America Competes " to help the Biden Administration and Congress understand that American success relies on American Chemistry.
That's why we are launching ' Chemistry Creates, America Competes .'
The American Chemistry Council's mission is to advocate for the people, policy, and products of chemistry that make the United States the global leader in innovation and manufacturing.