Adolescence

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

Retrieved on: 
Friday, March 22, 2024
Diphenhydramine, Anaphylaxis, Hook effect, Pre-exposure prophylaxis, Half-life, Risk, Bone marrow, COVID-19, Patient, Metoprolol, Adrenaline, Epitope, DSM-IV codes, SARS-CoV-2, Death, Adolescence, Bank statement, Post-exposure prophylaxis, Clinical trial, CDC, Antibody, Vaccination, Safety, Immunodeficiency, Vaccine, FDA, Food, Medicine

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points: 
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • “The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.
  • It was developed using INVYMAB™, the company’s platform approach which combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
  • The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening.

Belite Bio Announces PMDA Submission of Tinlarebant for Stargardt Disease Clinical Trial in Japan

Retrieved on: 
Friday, March 22, 2024
Retina, Medication, SAN, NDA, Adolescence, Clinical trial, Safety, Pharmacokinetics, PMDA, Therapy, DRAGON, Pharmaceutical industry

In the Phase 2 trial, 42% of Tinlarebant-treated subjects (5 out of 12) did not develop atrophic retinal lesions during the 24-month treatment period

Key Points: 
  • In the Phase 2 trial, 42% of Tinlarebant-treated subjects (5 out of 12) did not develop atrophic retinal lesions during the 24-month treatment period
    SAN DIEGO, March 22, 2024 (GLOBE NEWSWIRE) -- Belite Bio, Inc (NASDAQ: BLTE) (“Belite Bio” or the “Company”), a clinical-stage biopharmaceutical drug development company focused on advancing novel therapeutics targeting degenerative retinal diseases that have significant unmet medical needs, today announces its submission to the Pharmaceuticals and Medical Devices Agency (PMDA) to initiate a clinical trial of Tinlarebant in adolescent STGD1 in Japan (“DRAGON II”).
  • The DRAGON II trial is a combination of Phase 1b open-label study to evaluate the pharmacokinetics and pharmacodynamics of Tinlarebant in Japanese adolescent STGD1 subjects and a Phase 2/3, global, multicenter, double-masked, placebo-controlled, randomized study designed to evaluate the efficacy, safety and tolerability of Tinlarebant in adolescent STGD1 subjects.
  • Approximately 60 subjects, aged 12 to 20 years old, including approximately 10 Japanese subjects, are targeted for enrollment in the Phase 2/3 portion of the trial with a 1:1 randomization (tinlarebant:placebo).
  • The data from Japanese subjects is intended to facilitate future NDA applications in Japan.

Tonix Pharmaceuticals Announces Poster Presentation Describing Discovery of Novel Next-Generation Oxytocin Analogues at the American Chemistry Society (ACS) Spring 2024 Meeting

Retrieved on: 
Thursday, March 21, 2024
MGH, Eating, Obesity, Oxytocin, Patient, Weight loss, Binge eating disorder, University, Prader–Willi syndrome, Tonix Pharmaceuticals, IND, American Chemical Society, Magnesium, Adolescence, Insulin resistance, Hospital, Safety, ACS, Social anxiety disorder, Spectrum, Pain, Nasal administration, Poster

CHATHAM, N.J., March 21, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announces a poster presentation at the American Chemistry Society (ACS) Spring 2024 Meeting, held March 17-21, 2024, in New Orleans, Louisiana. A copy of the poster is available under the scientific presentations page of the Tonix website at www.tonixpharma.com.

Key Points: 
  • A copy of the poster is available under the scientific presentations page of the Tonix website at www.tonixpharma.com .
  • The poster presentation titled, Oxytocin Analogs with Enhanced Craniofacial Antinociceptive Effects in Low Magnesium Formulations, describes the discovery and characterization of novel oxytocin analogues that are candidate treatments for craniofacial pain, excessive eating (including Prader Willi Syndrome), and endocrinological conditions including bone health in autism and insulin resistance.
  • “Intranasal oxytocin has several potential therapeutic applications,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals.
  • The Phase 2 ‘STROBE’ study at MGH is investigating the efficacy and safety of TNX-1900 as a novel therapeutic agent to reduce binge eating frequency in adults with binge-eating disorder.

Fennec Pharmaceuticals Reports Full Year and Fourth Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 21, 2024
AYA, Research, Remuneration, Civil service commission, Administration, Conference, Net, Growth, Young adult, Fennec, FENC, Patient, Into, G&A, NCCN, Adolescence, Marketing, MHRA, TSX, European Commission, FDA, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the fiscal year ended December 31, 2023 and provided a business update.

Key Points: 
  • ET ~
    RESEARCH TRIANGLE PARK, N.C., March 21, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the fiscal year ended December 31, 2023 and provided a business update.
  • PEDMARQSI was granted EU marketing authorization by the European Commission in June 2023, and received UK approval from the MHRA in October 2023.
  • Achieved PEDMARK net product revenue of approximately $9 million and $21 million for the fourth quarter and full year 2023, respectively.
  • Financial Results for the Fourth Quarter and Fiscal Year Ended December 31, 2023
    Net Sales – Net product sales of $21.3 million in fiscal 2023 compared to $1.5 million in 2022.

Rose Hill Partners with University of Guelph for Groundbreaking Study to Advance Research for the Potential Benefits of Psilocybin Mushrooms to Address Autism in the Adolescent Brain

Retrieved on: 
Thursday, March 21, 2024
Psilocybin, University of Guelph, Research, Certification, Brain, Learning, University, Memory, Associate, Partnership, Patient, Knowledge, Fungus, Agriculture, Anxiety, Adolescence, Autism spectrum, Biomedical sciences, Spectrum, ASD, Biomass, Pharmaceutical industry

This collaboration marks a significant milestone for both entities as they embark on a pioneering exploration of the potential benefits of psilocybin to address autism in the adolescent brain, the first-of-its-kind partnership in this space.

Key Points: 
  • This collaboration marks a significant milestone for both entities as they embark on a pioneering exploration of the potential benefits of psilocybin to address autism in the adolescent brain, the first-of-its-kind partnership in this space.
  • The collaborative preclinical research will focus on exploring and standardizing the chemical diversity of Rose Hill’s psilocybin mushrooms, legally imported from Jamaica to Canada for the work.
  • Additionally, utilizing a rodent model, the study will investigate their potential application in Autism Spectrum Disorders (ASD).
  • Psilocybin mushrooms, known for their psychoactive properties, have long captivated the scientific community's interest due to their potential therapeutic applications and unique biochemical composition.

Taysha Gene Therapies Reports Full Year 2023 Financial Results and Provides Corporate and Clinical Updates

Retrieved on: 
Tuesday, March 19, 2024
Diary, Patient, IND, Adolescence, Pediatrics, Therapy, FAAP, Rett syndrome, Research, Central nervous system, Risk, Webcast, CNS, Ageing, CHU, Safety, AAV, Mutation, Development, MECP2, Disease, Associate, Sleep, Șaeș, Dysrhythmia, FRCP, MTD, Movement, IDMC, VG, Hyperventilation, Principal, Administration, Index, Seizure, CTA, Female, MHRA, Phenotype, ID, Frasier, Pharmaceutical industry

Notably, she has vastly increased interest in social communication and activities at week 35 compared to earlier post-treatment assessments.

Key Points: 
  • Notably, she has vastly increased interest in social communication and activities at week 35 compared to earlier post-treatment assessments.
  • Dr. Schultz is a board-certified, licensed pediatric neurologist experienced in treating patients with Rett syndrome and leading gene therapy clinical trials.
  • She brings more than 17 years of clinical experience and will lead the Company’s clinical development, clinical operations, medical affairs and safety activities.
  • ET to review its financial and operating results and to provide corporate and clinical updates.

Pharvaris Announces Phase 3 Clinical Study Design for Recently Initiated RAPIDe-3 Study, and Presents Quality-of-Life Improvement and Caregiver Behavior Data at Two Recent HAE Congresses

Retrieved on: 
Monday, March 18, 2024
Angioedema, Conference, EOP, Attack, Quality of life (healthcare), Network, Safety, HAE, Hereditary angioedema, Patient, Adolescence, Heredity, Country, National Congress, Physician, Medicine, Pharmaceutical industry

“We are committed to the continued advancement of our clinical development program of deucrictibant to fulfill unmet needs of current HAE treatment,” said Berndt Modig, Chief Executive Officer of Pharvaris.

Key Points: 
  • “We are committed to the continued advancement of our clinical development program of deucrictibant to fulfill unmet needs of current HAE treatment,” said Berndt Modig, Chief Executive Officer of Pharvaris.
  • The RAPIDe-3 study is designed to assess the effectiveness of deucrictibant in addressing that unmet need.
  • RAPIDe-3 is a randomized, double-blind, placebo-controlled, crossover study, which is designed to enroll approximately 120 adolescent and adult participants globally.
  • The data illustrates that HRQoL is negatively impacted, including functional and psychological impairment, in people with HAE.

Benevis Report Emphasizes the Need to Prioritize Adolescent Dental Health in Honor of World Oral Health Day

Retrieved on: 
Thursday, March 14, 2024
Research, Health, Dental care, Dentistry, Herbal cigarette, Growth, Caregiver, White, Risk, Education, Patient, Adolescence, History, Tooth decay, Children's Health Insurance Program, World Oral Health Day, Impact, Plaque, SDOH, Smoking, Crowding, Ortho, Jaw, Parent, Brace

"Access to quality dental care should be easy, especially when it's essential; however, millions of adolescents face barriers to treatment or lack of dental hygiene resources and education for healthy smiles," said Bryan Carey, CEO of Benevis. "As adolescents move closer to adulthood or further away from the support of their parents' dental insurance coverage, establishing strong oral health habits that they can maintain over a lifetime becomes even more important. This work begins in the household and within their dental home--the ongoing relationship with a dental provider--to prevent the early onset of dental disease and teach healthy behaviors." 

Key Points: 
  • Many oral diseases and harmful health behaviors managed by adults begin in adolescence.
  • Harmful behaviors with implications for adverse oral health outcomes, like dietary habits, smoking, vaping, and substance use, also become more common in adolescent years.
  • In the U.S., social determinants of health (SDOH) have risk factors that are directly linked to poor oral health outcomes and are attributed to social, economic, and geographic barriers.
  • Expanding access to equitable oral healthcare to support dental disparities during this vital stage of life is essential to adolescent health and well-being.

Acadia Healthcare Appoints Dr. Stephanie Eken as Chief Medical Officer

Retrieved on: 
Thursday, April 4, 2024
Mental Health, Health, Hospitals, Physical Therapy, Managed Care, General Health, Psychiatry, Patient, Mental health, Child, University, Adolescence, Pediatrics, Acadia Healthcare, Safety, Multimedia, Medical device

Acadia Healthcare Company, Inc. (NASDAQ: ACHC) today announced the appointment of Dr. Stephanie Eken as the Company’s new chief medical officer.

Key Points: 
  • Acadia Healthcare Company, Inc. (NASDAQ: ACHC) today announced the appointment of Dr. Stephanie Eken as the Company’s new chief medical officer.
  • View the full release here: https://www.businesswire.com/news/home/20240404108920/en/
    Acadia Healthcare Appoints Dr. Stephanie Eken as Chief Medical Officer (Photo: Business Wire)
    “Acadia is thrilled to welcome Dr. Eken as our new chief medical officer,” said Chris Hunter, Chief Executive Officer of Acadia Healthcare.
  • “This is an exciting time to join Acadia Healthcare,” said Dr. Eken.
  • Dr. Genovese departs Acadia after 10 years with the Company, seven of those as its chief medical officer.

Nourish Raises $35M Series A to Expand Access to Registered Dietitians

Retrieved on: 
Wednesday, March 27, 2024
Other Health, Software, Telemedicine, Virtual Medicine, Oncology, Apps, Applications, Technology, Artificial Intelligence, Fitness & Nutrition, Health Insurance, Cardiology, Health, Diabetes, Blood pressure, Partner, BoxGroup, Growth, Y Combinator, Disease, TCV, Patient, Conditional sentence, Weight loss, Food, Thrive Capital, Index Ventures, Cancer, NPS, Insurance, Eating disorder, Adolescence, Diet, RDS, Access, Prediabetes, Medicine

Nourish , a telenutrition platform that connects people to registered dietitians covered by insurance, announced today that it has raised $35 million in Series A funding.

Key Points: 
  • Nourish , a telenutrition platform that connects people to registered dietitians covered by insurance, announced today that it has raised $35 million in Series A funding.
  • With $44M in total funding since its founding in 2021, Nourish plans to accelerate development of its digital platform for patients and providers, expand its network of registered dietitians (RDs), and deepen its strategic partnerships with insurance companies.
  • “Our goal is to create a win-win-win for patients, providers, and payers,” said Sam Perkins, co-founder, President and COO of Nourish.
  • “Nourish aims to help tens of millions of Americans by providing access to a dietitian and the incredible nutritional education, accountability, and care that they provide.