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Veru Submits IND Application to FDA for the Development of Enobosarm to Prevent Muscle Loss While Augmenting Fat Loss in Combination with GLP-1 Drugs for Weight Loss

Retrieved on: 
Lundi, janvier 8, 2024

Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are very effective drugs that result in significant weight loss.

Key Points: 
  • Glucagon-like peptide-1 receptor agonist (GLP-1 RA) drugs are very effective drugs that result in significant weight loss.
  • Unfortunately, up to 50% of the total weight loss comes from muscle which is problematic as muscle is necessary for metabolism, strength, and physical function.
  • According to the CDC, 41.5% of older U.S. adults have obesity and could benefit from a weight loss medication.
  • Patients with critically low muscle mass may experience muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality.

Over 80% of Caregivers Experience Emotional and Physical Strain Related to Caregiving, BraunAbility Survey Finds

Retrieved on: 
Jeudi, novembre 16, 2023

This and more caregiver insights were uncovered in BraunAbility’s 2023 Drive for Inclusion Report Card , an annual publication highlighting issues related to accessibility and inclusion.

Key Points: 
  • This and more caregiver insights were uncovered in BraunAbility’s 2023 Drive for Inclusion Report Card , an annual publication highlighting issues related to accessibility and inclusion.
  • The findings come from a survey of The Driving Force, BraunAbility’s online survey community of people with mobility challenges and their caregivers.
  • The survey found:
    88.1% of caregivers face emotional strain because of caregiving.
  • One Driving Force member and caregiver, Tricia, wrote, “All the emotional, physical, and mental toll goes unseen or unappreciated.

Veru Reports Muscle Data from 5 Clinical Studies of Enobosarm that Support the Advancement of Enobosarm in Combination with Weight-Loss GLP-1 Drugs, Ozempic®, Wegovy®, or Mounjaro®, to Optimize Weight Loss by Preventing Muscle Wasting and Further Increasi

Retrieved on: 
Mercredi, octobre 4, 2023

MIAMI, FL, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of obesity, breast cancer and for viral induced ARDS, today announced that the Company will advance its proprietary novel agent, enobosarm, a selective androgen receptor modulator (SARM), into a Phase 2b clinical trial in combination with weight-loss GLP-1 drugs, Ozempic (semaglutide), Wegovy (semaglutide), or Mounjaro (tirzepatide) to evaluate the efficacy and the safety of enobosarm to further increase fat loss while preventing the significant muscle wasting that occurs with weight-loss GLP-1 drugs.

Key Points: 
  • Specifically, enobosarm therapy could augment the preferential loss of fat mass while preventing the loss of critical muscle mass and bone mineral density.
  • Enobosarm treatment could also preserve or improve muscle strength and physical function in older adults being treated with a weight loss drug.
  • The primary endpoint of the study will be change in total lean body mass (muscle) from baseline to 4 months.
  • Key secondary endpoints will be change from baseline to 4 months in total fat mass, insulin resistance (HOMA-IR), and body weight.

Wheelchair-Accessible Winnebago® Rental at United Access Opens New Roads for Adventurers with Mobility Challenges

Retrieved on: 
Vendredi, juillet 21, 2023

For the more than 41 million Americans with a mobility disability in the United States [1] , vacationing can be filled with uncertainties and challenges.

Key Points: 
  • For the more than 41 million Americans with a mobility disability in the United States [1] , vacationing can be filled with uncertainties and challenges.
  • The Roam offers the peace of mind of accessible accommodations
    with the privacy and comforts of home in a compact, easy-driving package.
  • More than an ADA-compliant RV, the Roam was purpose-built for travelers with mobility challenges.
  • “The freedom of the open road is a quintessential part of American travel,” said Chad Blake, Senior Vice President of Store Sales and Operations at United Access.

Biophytis has filed with the FDA for authorization to initiate SARA-31 phase 3 study in sarcopenia

Retrieved on: 
Lundi, juillet 10, 2023

The launch of the Phase 3 program follows promising results from the SARA-INT Phase 2b study and discussions with health authorities in 2022.

Key Points: 
  • The launch of the Phase 3 program follows promising results from the SARA-INT Phase 2b study and discussions with health authorities in 2022.
  • Based on the results of the previous study and feedback from the U.S. government agency, Biophytis is starting its Phase 3 program by filing the first ever Phase 3 application (SARA-31) in sarcopenia with the FDA.
  • The objective of the SARA-31 phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of mobility disability.
  • Biophytis expects a response from the regulatory authorities during the third quarter of 2023, which would enable Biophytis to initiate the study in the United States.

Biophytis has filed with the EMA for authorization to initiate SARA-31 phase 3 study in sarcopenia

Retrieved on: 
Lundi, mai 15, 2023

The launch of the Phase 3 program follows encouraging results from the SARA-INT Phase 2b study and interactions with health authorities in 2022.

Key Points: 
  • The launch of the Phase 3 program follows encouraging results from the SARA-INT Phase 2b study and interactions with health authorities in 2022.
  • Based on the Phase 2b results and feedback from the agencies, Biophytis is starting its Phase 3 programme by filing the first Phase 3 (SARA-31) application in Europe.
  • The objective of the SARA-31 phase 3 study in sarcopenia is to evaluate the efficacy and safety of Sarconeos (BIO101) in the treatment of sarcopenic patients at risk of mobility disability.
  • Biophytis expects a response from the regulatory authorities in the next quarter, which would allow Biophytis to initiate the study in Belgium in the following quarter.

Biophytis presents the development of Sarconeos (BIO101) in Phase 3 for the treatment of Sarcopenia at the 15th SCWD International Congress

Retrieved on: 
Lundi, juin 27, 2022

Sarconeos (BIO101) has the potential to be the first drug candidate ever moving into Phase 3 in Sarcopenia.

Key Points: 
  • Sarconeos (BIO101) has the potential to be the first drug candidate ever moving into Phase 3 in Sarcopenia.
  • The design of this study may however evolve depending on the discussions currently underway with the European and American health authorities.
  • Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally,) just achieved its phase 2 development as a treatment for sarcopenia in the United States and Europe (SARA-INT).
  • A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne Muscular Dystrophy (DMD).

Biophytis to meet with FDA to advance Sarconeos (BIO101) development in Sarcopenia from Phase 2 to Phase 3

Retrieved on: 
Lundi, décembre 20, 2021

Stanislas Veillet, CEO of Biophytis said: "With the completion of Phase 2 and the preparation of Phase 3 with US regulators, Biophytis intends to initiate its Phase 3 program in H2 2022.

Key Points: 
  • Stanislas Veillet, CEO of Biophytis said: "With the completion of Phase 2 and the preparation of Phase 3 with US regulators, Biophytis intends to initiate its Phase 3 program in H2 2022.
  • Sarconeos (BIO101) is the first drug candidate with the potential to enter into Phase 3 and to be approved for the treatment of Sarcopenia.
  • Biophytis is now entering into key regulatory activities to advance Sarconeos development in sarcopenia from Phase 2 to Phase 3 registrational program, with the Type-B meeting (End-of-Phase 2 meeting) with regulators to discuss Phase 2b results and Phase 3 protocol.
  • Biophytis intends to target, in the Phase 3, similar population and endpoints which were evaluated in Phase 2.

Global Wheelchair Markets, 2021-2028: Breakdown by Product (Manual, Electric), Category (Adult, Pediatric), Application (Homecare, Hospitals, Ambulatory Surgical Centers) - ResearchAndMarkets.com

Retrieved on: 
Jeudi, novembre 18, 2021

It is mainly used for the purpose of indoor or both indoor and outdoor locomotion.

Key Points: 
  • It is mainly used for the purpose of indoor or both indoor and outdoor locomotion.
  • Increase in life span and numbers of elderly persons at a global level is one of the key reasons expected to contribute towards the growth of the market.
  • Rise in number of disorders requiring a mobility device is also one of the key factors expected to contribute to market growth.
  • The manual product segment led the segment in terms of revenue share in 2020 owing to its increasing use in hospitals.

Californians "Get Ready to ShakeOut" this Thursday, October 21!

Retrieved on: 
Jeudi, octobre 21, 2021

"The stateis committed to usingthe best available science and technology to provide life-saving tools," said Cal OES Director Mark Ghilarducci.

Key Points: 
  • "The stateis committed to usingthe best available science and technology to provide life-saving tools," said Cal OES Director Mark Ghilarducci.
  • "The good news is thatwe have grants available tohelpstrengthenolder houses against earthquake damage, witha seismic retrofitsomething many Californians should consider."
  • Any earthquake drill throughout 2021 can count as participation in ShakeOut, just visit ShakeOut.org to get started with your registration!
  • ShakeOut.org/messaging B-Roll, still graphics, and animated GIFs to aid reporting on general preparedness and ShakeOut.