Birth

As part of International Women’s Day 2024, Women’s Health Advocate calls on expeditious passage of C-64: An Act Respecting Pharmacare

Retrieved on: 
Friday, March 8, 2024

OTTAWA, March 08, 2024 (GLOBE NEWSWIRE) -- The Society of Obstetricians and Gynaecologist of Canada (SOGC) recognizes and celebrates the incredible contributions of women in Canadian society part International Women’s Day!

Key Points: 
  • OTTAWA, March 08, 2024 (GLOBE NEWSWIRE) -- The Society of Obstetricians and Gynaecologist of Canada (SOGC) recognizes and celebrates the incredible contributions of women in Canadian society part International Women’s Day!
  • Access to contraception is not only a matter of reproductive rights but also a fundamental aspect of public health and equity.
  • As part of the SOGC’s mission to help empower a woman’s ability to be her own health advocate, the SOGC has a suite of six websites devoted to education and knowledge.
  • Afterall, women’s healthcare is a non-partisan issue!” – Dr. Diane Francoeur, Chief Executive Officer, SOGC.

Lantheus Announces the FDA Approval of DEFINITY® (Perflutren Lipid Microsphere) for Pediatric Patients

Retrieved on: 
Monday, March 4, 2024

This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border.

Key Points: 
  • This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border.
  • Currently, DEFINITY is the most utilized, extensively studied, and a trusted diagnostic ultrasound enhancing agent in the U.S.1-3
    “The expanded indication for DEFINITY is a testament to the rigorous research and development efforts undertaken by Lantheus to address unmet medical needs of pediatric patients,” said Jean-Claude Provost, MD, Chief Medical Officer.
  • “We are proud that this approval will extend the benefits of DEFINITY to healthcare professionals who work with these young individuals.”
    Clinical studies have substantiated the efficacy and safety of DEFINITY in pediatric patients.
  • The Kutty and Fine studies each reported successful left ventricular opacification in all participants.

Health Advocate Applauds Federal Government in Free Access to Contraceptives for Canadians

Retrieved on: 
Thursday, February 29, 2024

OTTAWA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- The Society of Obstetricians and Gynaecologist of Canada (SOGC) applauds the Canadian government on today’s historic announcement to include free access for prescription contraceptives as part of a National Framework for Pharmacare.

Key Points: 
  • OTTAWA, Feb. 29, 2024 (GLOBE NEWSWIRE) -- The Society of Obstetricians and Gynaecologist of Canada (SOGC) applauds the Canadian government on today’s historic announcement to include free access for prescription contraceptives as part of a National Framework for Pharmacare.
  • This announcement begins a generational shift across Canada in terms of access and the future of women’s health care at large.
  • Access to contraception is not only a matter of reproductive rights but also a fundamental aspect of public health and equity.
  • “The SOGC is pleased with today’s announcement from the federal government and its commitment to women’s health care in Canada.

Philips launches new Azurion neuro biplane system at #ECR2024 to speed up and improve minimally invasive diagnosis and treatment of neurovascular patients

Retrieved on: 
Tuesday, February 27, 2024

As healthcare providers strive to deliver high-quality care to patients, at #ECR2024 Philips is partnering with its customers to improve productivity and access to more sustainable healthcare.

Key Points: 
  • As healthcare providers strive to deliver high-quality care to patients, at #ECR2024 Philips is partnering with its customers to improve productivity and access to more sustainable healthcare.
  • Minimally invasive procedures enabled by interventional systems like Azurion are a key part of the diagnosis and treatment pathway for stroke, where every minute counts in conserving the patient’s quality-of-life.
  • Interventional systems are also used to precisely plan and carry out complex neurovascular procedures such as the repair of brain aneurysms and birth defects.
  • By allowing neuro interventionists to treat more patients, more efficiently, with potentially better outcomes, the new Philips Azurion neuro biplane system enhances both the staff and patient experience and contributes to lower cost of care.

ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

Retrieved on: 
Tuesday, March 12, 2024

The completed comments form should be sent to

Key Points: 
    • The completed comments form should be sent to
      [email protected]
      *For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
      to align with ICH E2D(R1) guideline.
    • 18
      July 2003

      E2D

      Approval by the Steering Committee under Step 4 and
      recommendation for adoption to the three ICH
      regulatory bodies.

    • 12
      November 2003

      New
      Codification
      November
      2005
      E2D

      E2D

      Revision of E2D
      Code

      History

      E2D(R1) Endorsement by the Members of the ICH Assembly
      under Step 2 and release for public consultation.

    • Date

      New
      Codification

      5 February 2024

      E2D(R1)

      POST-APPROVAL SAFETY DATA:
      DEFINITIONS AND STANDARDS FOR MANAGEMENT AND
      REPORTING OF INDIVIDUAL CASE SAFETY REPORTS
      E2D(R1)
      ICH Consensus Guideline
      Table of Contents
      1.

    • The ICH E2D guideline provides guidance on definitions and standards for post-

      5

      approval individual case safety reporting, as well as good case management practices.

    • Detailed guidance on the

      9

      specific structure, format, standards, and data elements for transmitting Individual Case Safety

      10

      Reports (ICSRs) is provided in the ICH E2B guideline.

    • Guidance on periodic reporting of

      11

      aggregated safety data is covered in the ICH E2C guideline.

    • 12

      This guideline provides recommendations that are harmonised to the extent possible given

      13

      differences in post-market safety reporting requirements among ICH regions.

    • 25

      2.1.2

      Adverse Drug Reaction (ADR)

      26

      Adverse drug reactions, as defined by local and regional requirements, concern noxious and

      27

      unintended responses to a medicinal product.

    • 66

      Product labelling may include information related to ADRs for the pharmaceutical class to

      67

      which the medicinal product belongs.

    • In some cases, ?other observations? can occur

      78

      without any associated AEs/ADRs, while in other cases ?other observations? can occur with

      79

      an associated AE/ADR.

    • 84

      For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other

      85

      regions refer to AEs.

    • 86

      Refer to local and regional requirements for specifications and requirements on the reporting

      87

      of AEs or ADRs to each Regulatory Authority.

    • 89

      2.2

      90

      An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific

      91

      point of time.

    • Cases missing any of the above criteria do not qualify for reporting; due diligence

      99

      should be exercised to collect the missing criteria.

    • 6

      104

      An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,

      105

      Other Observations), or both.

    • Primary sources, often referred

      112

      to as ?reporters?, include healthcare professionals and consumers who provide facts about a case

      113

      to the MAH or regulatory authority.

    • 127

      2.7

      128

      A digital platform is the software and technology used to enable transmission of information

      129

      between users (see Section 4.3, Digital Platforms).

    • Expedited Report

      Primary Source

      Healthcare Professional (HCP)

      Consumer

      Digital Platform

      7

      130

      2.8

      131

      An organised data collection system (ODCS) is an activity that gathers data in a planned manner,

      132

      thereby enabling review to be performed.

    • MAHs should also follow the

      286

      advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to

      13

      287

      regulatory authorities.

    • MAHs may conduct an MRP

      395

      using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be

      396

      selected.

    • 564

      Terms (e.g., AEs/ADRs, indication, and medical conditions) in the narrative should be accurately

      565

      reflected in appropriate ICH E2B data elements.

    • 638

      Regulatory Authorities and MAHs should consider and manage duplicates when reviewing

      639

      pharmacovigilance data, as duplicates negatively impact signal detection.

    • 651

      Duplicate detection relies on good quality data and is generally based on similarities but should

      652

      take into account that information in ICSRs may differ between reporters.

ADAMEVE.COM ASKS "ARE AMERICANS' REPRODUCTIVE RIGHTS BEING TAKEN AWAY?"

Retrieved on: 
Thursday, March 7, 2024

This month, the company surveyed over 1000 people asking if they felt that Americans' reproductive rights are being taken away.

Key Points: 
  • This month, the company surveyed over 1000 people asking if they felt that Americans' reproductive rights are being taken away.
  • Only 22% of the respondents (24% of the males and 22% of the females) did not feel their reproductive rights are being taken away.
  • "Reproductive rights include having the ability to decide whether and when to have children," says Dr. Jenni Skyler, PhD, LMFT, CST, and resident sexologist at Adam & Eve.
  • And as more of these rights are taken away, I encourage adults to vote to protect their reproductive and human rights as they see fit."

For Women Using GLP-1 Receptor Agonists who take Oral Birth Control Pills, Hormone-Free Phexxi Contraceptive Gel is a Logical Solution to Help Prevent Unintended Pregnancy

Retrieved on: 
Thursday, March 7, 2024

SAN DIEGO, March 7, 2024 /PRNewswire/ -- Use of GLP-1 receptor agonists, or GLP-1s, is skyrocketing in the United States, with more than nine million prescriptions for Ozempic, Wegovy, Mounjaro, and similar diabetes and obesity drugs written during the last three months of 2022 alone.1 Zepbound weekly prescriptions hit 25,000 in December 2023, just one month after it was approved to treat obesity.2 These drugs may make oral birth control pills less effective at certain points in the dosing schedule, making an unintended pregnancy more likely.

Key Points: 
  • This highlights the critical need for a non-systemic, non-hormonal method, like Phexxi, to prevent unintended pregnancy."
  • Users of oral birth control considering GLP-1 treatment are encouraged to plan ahead to prevent unintended pregnancy.
  • Having a contraceptive strategy in place and the right product at your fingertips enables spontaneous intimacy no matter where you are in your GLP-1 dosing schedule.
  • An on-demand, hormone-free method is a logical choice to provide these patients additional protection they need.

Black Women for Wellness Launches Empower 25 Campaign: Amplifying Black Male Voices in Reproductive Justice

Retrieved on: 
Wednesday, March 6, 2024

Founded in 1997, Black Women for Wellness' mission has always been the health and well-being of Black women and girls through health education, empowerment and advocacy – particularly within the reproductive justice movement.

Key Points: 
  • Founded in 1997, Black Women for Wellness' mission has always been the health and well-being of Black women and girls through health education, empowerment and advocacy – particularly within the reproductive justice movement.
  • Too often, the voices of Black men have been unheard and overlooked in discussions around reproductive rights.
  • Empower 25 is an opportunity to uplift and amplify Black male voices, ensuring that they have a voice in decisions that impact the well-being of the Black family as a whole.
  • "In 2023, we confronted the Black maternal health crisis head-on," states Janette Robinson Flint, Founder and Executive Director of Black Women for Wellness.

TVM Capital Healthcare Announces the Opening of Baraya Extended Care's First Outpatient Rehabilitation Clinic in Riyadh

Retrieved on: 
Wednesday, March 6, 2024

RIYADH, Saudi Arabia, March 6, 2024 /PRNewswire/ -- Baraya Extended Care KSA has launched its first rehabilitation outpatient clinic in Riyadh, Saudi Arabia, offering physical, occupational, speech and language therapy, plus advanced and intensive rehabilitation services. The clinic has the capacity to provide 3,000 rehabilitation sessions per month.

Key Points: 
  • Consequently, this area has been identified as a key priority of Vision 2030 to enhance the healthcare sector.
  • Baraya is a portfolio company of TVM Capital Healthcare's new fund in KSA, a highly specialised global healthcare investment firm operating in the Middle East since 2009.
  • Othman Abahussein, TVM Capital Healthcare Saudi Operating Partner, concluded: "Baraya emerges as a transformative initiative developed by TVM Capital Healthcare.
  • As a leading provider of rehabilitation and long-term care services, Baraya Extended Care addresses critical gaps within the healthcare sector, ensuring that every individual receives the care they deserve.

TVM Capital Healthcare Announces the Opening of Baraya Extended Care's First Outpatient Rehabilitation Clinic in Riyadh

Retrieved on: 
Wednesday, March 6, 2024

RIYADH, Saudi Arabia, March 6, 2024 /PRNewswire/ -- Baraya Extended Care KSA has launched its first rehabilitation outpatient clinic in Riyadh, Saudi Arabia, offering physical, occupational, speech and language therapy, plus advanced and intensive rehabilitation services. The clinic has the capacity to provide 3,000 rehabilitation sessions per month.

Key Points: 
  • Consequently, this area has been identified as a key priority of Vision 2030 to enhance the healthcare sector.
  • Baraya is a portfolio company of TVM Capital Healthcare's new fund in KSA, a highly specialised global healthcare investment firm operating in the Middle East since 2009.
  • Othman Abahussein, TVM Capital Healthcare Saudi Operating Partner, concluded: "Baraya emerges as a transformative initiative developed by TVM Capital Healthcare.
  • As a leading provider of rehabilitation and long-term care services, Baraya Extended Care addresses critical gaps within the healthcare sector, ensuring that every individual receives the care they deserve.