Off-label use

Goodroot Releases Guide for Healthcare Payers Weighing Coverage of Ozempic, Wegovy and Mounjaro

Retrieved on: 
Wednesday, June 14, 2023

As breakthrough obesity drugs Ozempic and Wegovy rapidly gain in popularity, the free guide is designed to help healthcare payers make decisions on covering these high-cost medications.

Key Points: 
  • As breakthrough obesity drugs Ozempic and Wegovy rapidly gain in popularity, the free guide is designed to help healthcare payers make decisions on covering these high-cost medications.
  • This guide compiles all of the available information to help payers make informed decisions."
  • "In the private sector, the perception of obesity drug coverage is undergoing a shift," reads the guide.
  • "Our mission at Goodroot is increasing access and affordability in healthcare," says Goodroot CEO Mike Waterbury.

Drugs that melt away pounds still present more questions than answers, but Ozempic, Wegovy and Mounjaro could be key tools in reducing the obesity epidemic

Retrieved on: 
Friday, June 2, 2023

Three drugs in particular – sold under the brand names Wegovy, Ozempic and Mounjaro – have shown remarkable effects on weight loss in clinical trials.

Key Points: 
  • Three drugs in particular – sold under the brand names Wegovy, Ozempic and Mounjaro – have shown remarkable effects on weight loss in clinical trials.
  • Globally, more than 650 million people are obese, and by 2030, an estimated 1 billion adults will be obese.
  • In my view, they warrant much more research before they become the basis for a new weight management protocol.

How these drugs work

    • Prolonged elevated blood sugar, if left untreated, can lead to heart disease, vision loss and even death.
    • At the same time, semaglutides also reduce the release of the hormone glucagon, which works opposite of insulin to increase blood sugar.
    • In non-diabetics, these two hormones work together to maintain normal blood sugar levels.
    • This dual-hormone action works to not only lower blood sugar levels and increase insulin sensitivity, but also slows the digestive system and decreases appetite.

Staggering results

    • Over 80% of participants lost more than 5% of their body weight, with the most common side effects being nausea, diarrhea, vomiting and constipation.
    • In April 2023, the pharmaceutical company Eli Lilly released the results of the second phase 3 clinical trial of Mounjaro.
    • The results were, quite frankly, amazing: Compared to a placebo, the 938 obese or overweight adults with type 2 diabetes lost more than 34 pounds, or roughly 15% of their body weight, with no required fitness and nutrition program.

Costs of obesity

    • The WHO defines obesity as when an adult or child has a body mass index, or BMI, over 30; a BMI over 25 is considered overweight.
    • In fact, obesity is responsible for nearly half of the total cost of chronic disease in the U.S. Studies show that obesity also leads to a decrease in life expectancy.
    • Recent data suggests that the direct medical costs of a person being obese in the U.S. is more than US$2,500 annually.
    • Predictions show the annual cost of obesity will be more than $4.3 trillion worldwide by 2030.
    • Since most Americans can’t afford these drugs, it’s reasonable to ask whether more should be done to decrease costs and increase access.

The age-old benefits of exercise and a healthy diet

    • Research has long since established that being physically active improves mental health, including memory, depressive symptoms and mood, as well as immune function and bone health.
    • Being active also reduces the risks of developing conditions like heart disease, type 2 diabetes and some cancers.
    • The health care field now has a new strategy for meaningful weight loss, but there are still more questions than answers.
    • Researchers are also just beginning to understand what happens when you stop using these new weight loss medications.

Therapy and Beyond ABA Provider for Autism Announces Leadership Changes

Retrieved on: 
Monday, April 17, 2023

FLOWER MOUND, Texas, April 17, 2023 /PRNewswire-PRWeb/ -- Therapy and Beyond, a leading provider of therapeutic services for children with autism in Texas, Oklahoma, and Colorado, announced today that Founder and Chief Executive Officer Dr. Regina Crone will transition into the president and chairwoman of the Board role. Former Chief Operating Officer Sean Crone was appointed the chief executive officer.

Key Points: 
  • Therapy and Beyond, a premier provider of ABA, Speech, and OT treatment for children with autism throughout Texas, Oklahoma, and Colorado, announces a new CEO.
  • ‒Twenty-four years ago, as an ABA Technician, while attending college, I found my passion for working with children with autism,– Dr. Crone said.
  • Mr. Crone shared: ‒Having been introduced into this field through my wife's passion, I have seen first-hand the difference excellent ABA therapy can make for children with autism.
  • I am excited to continue to lead together as we both focus on elevating excellence both therapeutically and operationally at Therapy and Beyond."

Real-World Evidence Solutions Global Market Report 2022: Need for Precise and Clear Information About the Safety and Efficacy of New Products Driving Adoption - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 25, 2022

The "Real-World Evidence Solutions Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Real-World Evidence Solutions Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.
  • The global real-world evidence solutions market size reached US$ 1.41 Billion in 2021.
  • Real-world evidence (RWE) refers to clinical evidence about the use and potential benefits or risks of medical products via real-world data (RWD).
  • Real-World Evidence Solutions Market Trends:
    The growing demand for RWE solutions to get precise and clear information about the safety and efficacy of new products represents one of the key factors driving the market.

6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices - 2021 Webinar - ResearchAndMarkets.com

Retrieved on: 
Friday, May 7, 2021

b'The "6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices" webinar has been added to ResearchAndMarkets.com\'s offering.\nIf you go "off label" with advertising and promotion, FDA\'s hammer can hit hard and seemingly out of the blue.\nAdvertising and promotion for devices is weak and lacks legal clarity.

Key Points: 
  • b'The "6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices" webinar has been added to ResearchAndMarkets.com\'s offering.\nIf you go "off label" with advertising and promotion, FDA\'s hammer can hit hard and seemingly out of the blue.\nAdvertising and promotion for devices is weak and lacks legal clarity.
  • Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA.
  • Policing social media has become a new regulatory responsibility and FDA is still trying to figure out how to deal with it.
  • Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them.

Algernon Pharmaceuticals to File End-of-Phase 2 Meeting Request with U.S. FDA for Possible Ifenprodil Phase 3 COVID-19 Trial

Retrieved on: 
Thursday, April 8, 2021

Algernon has now completed its initial review of the full data set from the Study and will be seeking guidance from the FDA on moving forward with a potential Phase 3 study.

Key Points: 
  • Algernon has now completed its initial review of the full data set from the Study and will be seeking guidance from the FDA on moving forward with a potential Phase 3 study.
  • As part of the EOP2 meeting request, the Company is preparing a briefing package that includes a summary of Study data and a protocol synopsis for a potential Phase 3 trial.
  • The EOP2 meeting is an essential part of the process to help guide the Company and determine the next steps forward.
  • Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

Algernon Pharmaceuticals Announces Plans for 2021

Retrieved on: 
Thursday, January 7, 2021

VANCOUVER, British Columbia, Jan. 07, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc.(CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the Company or Algernon) a clinical stage pharmaceutical development company, is pleased to provide an overview of the Companys primary plans for the upcoming calendar year.

Key Points: 
  • VANCOUVER, British Columbia, Jan. 07, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc.(CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the Company or Algernon) a clinical stage pharmaceutical development company, is pleased to provide an overview of the Companys primary plans for the upcoming calendar year.
  • The Company may also advance compounds for diseases that are rare in the population, referred to as orphan indications.
  • If the data is positive, the Company will consult with the U.S. FDA on an Emergency Use Authorization (EUA).
  • Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

More Evidence Presented for Why Hydroxychloroquine Should be Made Available, in a New Court Filing by the Association of American Physicians & Surgeons (AAPS)

Retrieved on: 
Wednesday, July 22, 2020

"Countries with underdeveloped health care systems are using HCQ early and attaining far lower mortality than in the United States, where [HHS and the FDA] impede access to HCQ."

Key Points: 
  • "Countries with underdeveloped health care systems are using HCQ early and attaining far lower mortality than in the United States, where [HHS and the FDA] impede access to HCQ."
  • "Citizens of the Philippines, Poland, Israel, and Turkey all have greater access to HCQ than American citizens do," observes AAPS General Counsel Andrew Schlafly.
  • AAPS rebuts arguments presented by the FDA, which implied that medications are approved as safe only for certain conditions.
  • In fact, HCQ and most medications have been approved without limitation, such that physicians can prescribe them for any off-label use.

6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices - ResearchAndMarkets.com

Retrieved on: 
Tuesday, May 26, 2020

The "6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices" webinar has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "6-Hour Virtual Seminar on FDA Scrutiny of Promotion and Advertising Practices" webinar has been added to ResearchAndMarkets.com's offering.
  • If you go 'off label' with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue.
  • FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion.
  • With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion practices.

The global pharmaceutical label market is expected to reach an estimated $6.5 billion by 2024 with a CAGR of 5.7% from 2019 to 2024

Retrieved on: 
Monday, May 27, 2019

What are the drivers and challenges, and business risks in this pharmaceutical label (pharmaceutical label market, pharmaceutical off-label market, pharmaceutical label market report, pharma labeling, pharmaceutical labeling) market?

Key Points: 
  • What are the drivers and challenges, and business risks in this pharmaceutical label (pharmaceutical label market, pharmaceutical off-label market, pharmaceutical label market report, pharma labeling, pharmaceutical labeling) market?
  • Q.5 What are the business risks and competitive threats in this pharmaceutical label (pharmaceutical label market, pharmaceutical off-label market, pharmaceutical label market report, pharma labeling, pharmaceutical labeling) market?
  • Q.9 Who are the major players in this pharmaceutical label (pharmaceutical label market, pharmaceutical off-label market, pharmaceutical label market report, pharma labeling, pharmaceutical labeling) market?
  • Q.10 What M & A activity has occurred in the last 5 years in this pharmaceutical label (pharmaceutical label market, pharmaceutical off-label market, pharmaceutical label market report, pharma labeling, pharmaceutical labeling) market?