US Food Sovereignty Alliance

Ellipses EP0031/A400 granted Orphan Drug Designation from the US Food and Drug Administration

Retrieved on: 
Thursday, November 23, 2023
Safety, Food, ODD, US Food Sovereignty Alliance, IND, Patient, FDA, Partnership, Drug development, RET, Orphan, Serotonin reuptake inhibitor, AACR, Pharmaceutical industry, SRI, Ellipses

LONDON, Nov. 23, 2023 /PRNewswire/ -- Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announces today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its compound, EP0031/A400, a potential treatment for tissue-agnostic RET fusion-positive solid tumours.

Key Points: 
  • LONDON, Nov. 23, 2023 /PRNewswire/ -- Ellipses Pharma ("Ellipses"), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announces today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its compound, EP0031/A400, a potential treatment for tissue-agnostic RET fusion-positive solid tumours.
  • The FDA grants ODD for investigational treatments for rare diseases, such as RET fusion-positive solid tumours, defined as affecting fewer than 200,000 people in the United States.
  • ODD qualifies the developer for certain incentives with the goal of accelerating drug development for patients, including tax credits and seven years of market exclusivity in the US upon approval by the FDA.
  • [1]
    It is estimated that RET mutations and rearrangements may be responsible for ~2% of all solid tumours.

PYC'S FOURTH DRUG CANDIDATE HAS DISEASE-MODIFYING POTENTIAL IN POLYCYSTIC KIDNEY DISEASE

Retrieved on: 
Monday, November 13, 2023
SAN, Food, Therapy, US Food Sovereignty Alliance, Kidney disease, Disease, PYC, IND, Patient, DSM-IV codes, Probability, FDA, Kidney, PKD, New Drug Application, Human, RNA, Swelling, 3D, Cyst, AEDST, Mutation, Drug development, Pharmaceutical industry, Cryptocurrency, Vaccine, Drug discovery

PERTH, Australia and SAN FRANCISCO, Nov. 13, 2023 /PRNewswire/ -- PYC Therapeutics today announces the results of a study conducted in human 3-dimensional models derived from patients with end-stage renal failure due to Autosomal Dominant Polycystic Kidney Disease (PKD). The results demonstrate that an investigational drug candidate designed by PYC (known as PYC-003) to address this disease at its root cause is effective. These 3D patient-derived cyst models represent the 'gold-standard' pre-clinical assay for evaluating drug candidates in this indication[8].

Key Points: 
  • The results demonstrate that an investigational drug candidate designed by PYC (known as PYC-003) to address this disease at its root cause is effective.
  • PYC-003 is the fourth program in the Company's development pipeline – joining three other first-in-class RNA drug candidates with disease-modifying potential currently progressing into or through human trials.
  • An Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to enable the commencement of human trials for this drug candidate is planned for H2 2024.
  • A New Drug Application in support of this candidate could be submitted following two clinical trials rather than the conventional three[11].

Virpax Pharmaceuticals Announces that Envelta™ Remains on Track for Trial in Humans Following FDA Review

Retrieved on: 
Tuesday, October 31, 2023
Other Health, Research, General Health, Pharmaceutical, Medical Devices, Infectious Diseases, Science, Surgery, Biotechnology, FDA, Other Science, Health, Post-traumatic stress disorder, Rat, Analgesic, Nanotechnology, National Center for Advancing Translational Sciences, IND, Central nervous system disease, Food, NCATS, Chronic pain, Hematology, Mortality, Morphine, US Food Sovereignty Alliance, CNS, Nanoparticle, Administration, Human, Traffic barrier, Transitive dependency, Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., Completeness, DRF, Thermoregulation, Animal, Brain, NIH, CFA, Pain management, Drug tolerance, Dog, Pain, MET, Hypersensitivity, Bangladesh Technical Education Board, Coagulation, Central nervous system, Pharmaceutical industry

Envelta utilizes a novel and patented intranasal drug delivery system, Molecular Envelope Technology (MET) to bypass the blood-brain barrier.

Key Points: 
  • Envelta utilizes a novel and patented intranasal drug delivery system, Molecular Envelope Technology (MET) to bypass the blood-brain barrier.
  • The MET was developed by Nanomerics, Ltd. , a UK-based nanotechnology research and development company that has licensed its MET-LENK to Virpax.
  • The nose-to-brain MET platform protects molecules from biodegrading and enhances the bioavailability of product candidates on its transport to the brain.
  • “We are grateful to the FDA for the thorough and clear direction that was provided to us in our pre-IND meeting.

United States Direct-to-Consumer (DTC) Genetic Testing Markets 2023: A $1.65 Billion Market by 2028 with Ancestry & 23andMe Dominating - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 31, 2023
Health, Genetics, Genetic testing, FDA, DSM-IV codes, Incidence, Food, Genetic, US Food Sovereignty Alliance, Research, Disease, Medicine, Cancer, DTC, Patient, Diagnosis, Genetic disorder, DNA, Pharmaceutical industry, Vaccine

This surge in interest has led to more people opting for Direct-to-Consumer (DTC) genetic testing, providing insights into their geographic origins and potential health risks.

Key Points: 
  • This surge in interest has led to more people opting for Direct-to-Consumer (DTC) genetic testing, providing insights into their geographic origins and potential health risks.
  • Genetic disorders are becoming more prevalent in the US, prompting individuals to seek DTC testing for both early detection and preventive measures.
  • DTC genetic testing offers valuable information about personalized nutrition, medical treatments, and therapies, contributing to informed healthcare decisions.
  • The growing interest in genetic testing, driven by curiosity, disease awareness, and the pursuit of personalized healthcare, is expected to continue shaping the genetic testing landscape in the United States.

FDA approves Novartis Cosentyx® as the first new biologic treatment option for hidradenitis suppurativa patients in nearly a decade

Retrieved on: 
Tuesday, October 31, 2023
Week, FDA, Psoriasis, HS, Flare, Harvard Medical School, Secukinumab, Beth Israel Deaconess Medical Center, MPH, Abscess, Doctor of Education, US Food Sovereignty Alliance, Hidradenitis suppurativa, Inflammation, HIV disease progression rates, EAST, Skin, International Association, Novartis, Disease, Medicine, Physician, Scar, Anxiety, Pain, Patient, Diagnosis, SUNRISE, Rheumatology, Pharmaceutical industry, Dermatology, MD

"This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option."

Key Points: 
  • "This approval marks an important milestone for countless patients who have been faced with limited treatment possibilities and who now have a new option."
  • "HS is one of the most devastating and exhausting skin diseases.
  • The pain of flares can be debilitating and limits my ability to work or participate in social activities.
  • "The approval of a new treatment option brings fresh hope to me and the HS community that we may find relief from the burden of the disease."

NAYZILAM® (midazolam) Results Published in 'Epilepsy & Behavior' Examining the Impact of Dose on Return to Full Baseline Function (RTFBF) for People with Seizure Clusters

Retrieved on: 
Tuesday, October 31, 2023
Science, Patient, FDA, UCB, Food, Health, ScS, Hobby, Work, US Food Sovereignty Alliance, Epilepsy, Epilepsy & Behavior, Quality of life, OLE, Caregiver, Recurrence, Seizure, Syndrome, Safety, Status epilepticus, Pharmaceutical industry, Residential care

This analysis showed the estimated median time to RTFBF, regardless of treatment with one or two doses, was 90 minutes.

Key Points: 
  • This analysis showed the estimated median time to RTFBF, regardless of treatment with one or two doses, was 90 minutes.
  • Patients were followed for a median of 17 months and 7 treated seizure clusters per patient.
  • "For people living with epilepsy who unfortunately experience seizure clusters, the ability to get back to their everyday lives after these episodes is critical.
  • Another 5-mg dose could be given if the seizure did not terminate within 10 minutes or if there was seizure recurrence within 6 hours.

NeuroTrigger Received FDA 510(k) for that its non-invasive muscle stimulation system (NTB)

Retrieved on: 
Monday, October 30, 2023
FDA, Element, US Food Sovereignty Alliance, NTB, Paralysis, Safety, Motion, Patient, Medical device

RAANANA, Israel, Oct. 30, 2023 /PRNewswire/ -- NeuroTrigger is pleased to announce that its non-invasive muscle stimulation system (NTB) has been granted 510(k) clearance by the US Food & Drug Administration (FDA) for the prevention or retardation of disuse atrophy and muscle re-education to maintain or increase range of motion.

Key Points: 
  • RAANANA, Israel, Oct. 30, 2023 /PRNewswire/ -- NeuroTrigger is pleased to announce that its non-invasive muscle stimulation system (NTB) has been granted 510(k) clearance by the US Food & Drug Administration (FDA) for the prevention or retardation of disuse atrophy and muscle re-education to maintain or increase range of motion.
  • The NTB system is portable, rechargeable, aesthetic, and user-friendly and is composed of 3 elements: a stimulator, a daily use /disposable electrode, and a mobile App., which controls the system.
  • This NTB system is designed to stimulate muscles in a controlled rhythm with an option to personalize the stimulation parameters for each patient's needs.
  • Dr Nikolai Kunicher, NeuroTrigger CEO commented that "This FDA milestone is important as we develop the technology for different clinical applications.

Muscular Dystrophy Association-Supported Drug AGAMREE® (vamorolone) Approved for the Treatment of Duchenne Muscular Dystrophy by the FDA

Retrieved on: 
Thursday, October 26, 2023
Steroid, Principal, FDA, Duke University Hospital, Research, University, NF-κB, Dean (education), Associate, Duke University, MDA, Diversified Pharmaceutical Services, Muscular Dystrophy Association, Binghamton University, Medical director, Rare disease, Weight gain, US Food Sovereignty Alliance, Doctor of Philosophy, Catalyst Pharmaceuticals, Vamorolone, Pediatrics, Disease, Clinical trial, Duchenne, Duchenne muscular dystrophy, DMD, Investment, Patient, Griffin, Bone density, Pharmaceutical industry, Nursing

New York, Oct. 26, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of AGAMREE® (vamorolone), a structurally unique steroidal anti-inflammatory drug to treat children and adolescents living with Duchenne muscular dystrophy (DMD).

Key Points: 
  • New York, Oct. 26, 2023 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) celebrates the US Food and Drug Administration (FDA) approval of AGAMREE® (vamorolone), a structurally unique steroidal anti-inflammatory drug to treat children and adolescents living with Duchenne muscular dystrophy (DMD).
  • This multi-functional drug shows potent inhibition of pro-inflammatory NFkB pathways via high-affinity binding to the glucocorticoid receptor, high-affinity antagonism for the mineralocorticoid receptor, and membrane stabilization properties.
  • This novel therapy, supported in part by MDA Venture Philanthropy, demonstrates similar efficacy to traditional corticosteroids with reduced negative downstream impacts or side effects.
  • “My son was diagnosed with Duchenne muscular dystrophy, and he was the first person dosed with vamorolone right before his 7th birthday.

22nd Century Group (XXII) Supports FDA Policy Advancements, Proposed Menthol Ban Now at OMB

Retrieved on: 
Thursday, October 26, 2023
FDA, Policy, Publishing, Health, White House, US Food Sovereignty Alliance, XXII, OMB, Smoking, Pacific Century Group, Disease, Interim, Public, Smoker, Management, Death, Tobacco

In April 2022, the FDA stated that these proposed policies had the potential to reduce disease and death associated with smoking and support smoking cessation.

Key Points: 
  • In April 2022, the FDA stated that these proposed policies had the potential to reduce disease and death associated with smoking and support smoking cessation.
  • The policy submissions, originally expected earlier this year, are more than a decade in the making.
  • The FDA officially began exploring the concept of a menthol ban in July 2013.
  • “The FDA has taken a significant step forward to enact federal enforcement on these important public health policies,” said John Miller, Interim Chief Executive Officer of 22nd Century Group.

October is ADHD Awareness Month

Retrieved on: 
Wednesday, October 25, 2023
JAMA, FDA, Drug Enforcement Administration, Attention, Education, Food, Child, Policy, American Medical Association, National Disability Employment Awareness Month, Prevalence, US Food Sovereignty Alliance, DEA, Conference, Journal, Drug, Approximation error, Letter, White, Caregiver, COVID-19, Annual International Conference on Real Options, ADDA, Woman, Patient, Diagnosis, Attention deficit hyperactivity disorder controversies, ADHD, ACO, Parent, Mental health, Dietary supplement, Nursing

Each October during ADHD Awareness Month, CHADD joins forces with the ADHD Coaches Organization (ACO) and the Attention Deficit Disorder Association (ADDA) to build a stronger understanding of ADHD, and to provide valuable programming and resources.

Key Points: 
  • Each October during ADHD Awareness Month, CHADD joins forces with the ADHD Coaches Organization (ACO) and the Attention Deficit Disorder Association (ADDA) to build a stronger understanding of ADHD, and to provide valuable programming and resources.
  • The theme for Awareness Month this year is Moving Forward with ADHD in 2023.
  • This ADHD Awareness Month, the experts at CHADD have identified three pressing concerns in need of attention if we are to move forward as a community in enabling individuals with ADHD to lead successful lives.
  • Beyond ADHD Awareness Month, the coalition members―CHADD, ACO and ADDA―will host the 2023 Annual International Conference on ADHD in Baltimore, Maryland, from November 30 to December 2, followed by an online conference option on December 5 and 6.