Swelling

Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis, 12/01/2017 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Finger, Growth, Face, Blood, Disease, Inflammation, Patient, Committee, Knowledge, Regulation, Systemic scleroderma, EMA, IRIS, Protein, Scleroderma, CB2, European, Collagen, COMP, Connective tissue, Skin, Heart, Sponsor, European Commission, Immune system, The, Safety, Swelling, Marketing, Pharmaceutical industry

Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis, 12/01/2017 Withdrawn

Key Points: 


Orphan designation: (6aR, 10aR)-3-(1',1'-dimethylheptyl)-delta-8-tetrahydro-cannabinol-9-carboxylic acid Treatment of systemic sclerosis, 12/01/2017 Withdrawn

Treace Celebrates 100,000 Lapiplasty® 3D Bunion Correction® Patient Milestone

Retrieved on: 
Monday, March 25, 2024
ABC, Hypoesthesia, Patient, Education, Foot, Bunion, Chronic pain, Quality of life, Life, Surgeon, Woman, Arthritis, Radio, Diving, Pain, Recurrence, Swelling, Parent

PONTE VEDRA, Fla., March 25, 2024 (GLOBE NEWSWIRE) -- Treace Medical Concepts, Inc. (“Treace” or the “Company”) (NasdaqGS: TMCI), a medical technology company driving a fundamental shift in the surgical treatment of bunions and related midfoot deformities through its flagship Lapiplasty® and Adductoplasty® Procedures, today announced that 100,000 patients have been treated with its patented Lapiplasty® 3D Bunion Correction® System.1 This milestone coincides with the first-ever National Bunion Day in the United States, which is being sponsored by Treace on April 16, 2024, and the launch of its new patient education and brand awareness campaign.

Key Points: 
  • “Achieving this important milestone is a testament to the tireless efforts of our team members and the trust of our surgeon customers and patients, all of whom have made our journey possible,” said John T. Treace, CEO and Founder of Treace.
  • “Since our initial surgical cases in 2015, Treace has been committed to educating people about surgical options that can provide lasting relief from bunion pain through our innovative procedures that are designed to minimize recovery time, reduce recurrence rates, and improve patient outcomes.
  • Today the Company also unveiled its latest campaign to continue to drive patient education and awareness of its Lapiplasty® Procedure.
  • Treace will premiere the “Future You” commercial on the finale of “The Bachelor” TV show on March 25, 2024 at 8:00 p.m. Eastern Time on the ABC network.

Orchard Therapeutics Outlines U.S. Launch Plans for Lenmeldy™ (atidarsagene autotemcel), the Only Approved Therapy for Children with Early-onset Metachromatic Leukodystrophy

Retrieved on: 
Wednesday, March 20, 2024
Encephalitis, ICER, Bone marrow, Patient, DSM-IV codes, Urinary tract infection, Travel, Child, Health technology assessment, Therapy, Children's Hospital of Philadelphia, Central nervous system, Risk, MLD, Qualification, Health, WAC, NBS, Nerve, Mutation, UCSF, Disease, Federation, Research, Acquisition, Genome, Rash, Stem cell, HSC, Hospital, Family, Swelling, FDA, Diagnosis, HTA, Caregiver, Traffic barrier, Viral, Fever, Kyowa Kirin, PSLI, Liver, Government, San Raffaele Hospital, ARSA, Pharmaceutical industry

TOKYO, LONDON and BOSTON, March 20, 2024 (GLOBE NEWSWIRE) -- Orchard Therapeutics, recently acquired by Kyowa Kirin with the goal of accelerating the delivery of new gene therapies to patients around the globe, today announced the details of its U.S. commercial launch of Lenmeldy™ (atidarsagene autotemcel), formerly known as OTL-200, the first FDA-approved therapy for the treatment of children with pre-symptomatic late infantile (PSLI), pre-symptomatic early juvenile, (PSEJ), or early symptomatic early juvenile (ESEJ)—collectively referred to as early-onset—metachromatic leukodystrophy (MLD).

Key Points: 
  • Prior to Lenmeldy, there were no treatment options in the U.S. for early-onset MLD beyond supportive and end-of-life care.
  • This approach has the potential to restore enzymatic function to stop or slow disease progression with a single treatment.
  • Utilizing results from such studies, a multi-stakeholder working group is finalizing a nomination to add MLD to the U.S.
  • Based on current timelines and assumptions, Orchard Therapeutics expects the nomination will be submitted in mid-year 2024.

Aquestive Therapeutics Announces Pivotal Study for Anaphylm™ (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting

Retrieved on: 
Thursday, March 14, 2024
Blood pressure, Sinai Hospital, Anaphylaxis, Absorption, Angioedema, Plasma, Type, PD, Patient, Heart rate, Adrenaline, NDA, Epinephrine autoinjector, Cmax, Trial of the century, Mouth, Therapy, Safety, Oral medicine, Allergy, Vomiting, Swelling, FDA, Study, Food, Pharmaceutical industry

“We are extremely pleased with the pivotal study results as well as our recent FDA interaction,” said Daniel Barber, President and Chief Executive Officer of Aquestive.

Key Points: 
  • “We are extremely pleased with the pivotal study results as well as our recent FDA interaction,” said Daniel Barber, President and Chief Executive Officer of Aquestive.
  • “We believe we have a clear understanding of the remaining clinical development steps necessary for a pre-NDA meeting with the FDA in the second half of the year.
  • These latest study results show that the sublingual administration of epinephrine provides rapid and sustained levels of epinephrine similar to approved treatments.
  • The FDA noted that substantial progress had been made in the Anaphylm clinical development program and did not outline any new clinical development requirements.

Oragenics Appoints James Kelly MD, Chief Medical Officer, to Lead Phase II Clinical Trials for Treating Concussion

Retrieved on: 
Monday, March 18, 2024
Pharmaceutical, Health, Neurology, Clinical Trials, Depression, Metabolism, Brain, NCE, Acute stress disorder, Concussion, Veterans' affairs, Executive, Common, Inflammation, Patient, United States Congress, TBI, Foundation (nonprofit), Anxiety, CTE, University, Military personnel, Oxidative stress, Human, GMP, Nasal cavity, Traumatic brain injury, DSM-IV codes, Phase, Traffic, Swelling, FDA, Animal, Pentagon, Chronic traumatic encephalopathy, Phase II, Marcus Foundation, Medical device

Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion.

Key Points: 
  • Oragenics’ lead drug candidate, ONP-002 is combined with its intranasal device intended for the treatment of mild Traumatic Brain Injury (TBI), aka concussion.
  • Dr. Kelly was also National Director of the Avalon Action Alliance TBI Programs for which the MIBH serves as the clinical coordinating center.
  • “I am excited to join Oragenics as its Chief Medical Officer at such an important and pivotal time in the drug development process.
  • Dr. Kelly has interacted with the FDA and clinical trials for brain injury throughout his esteemed career.

Merck Announces Plans to Conduct Clinical Trials of a Novel Investigational Multi-Valent Human Papillomavirus (HPV) Vaccine and Single-Dose Regimen for GARDASIL®9

Retrieved on: 
Wednesday, March 13, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Hypersensitivity, Pregnancy, Wart, Head, Congress, Recombinant, Multiple endocrine neoplasia, Dizziness, Safety, Vain, Headache, Bruise, Public, Syncope, Ageing, Merck & Co., Cervical intraepithelial neoplasia, Vulvar intraepithelial neoplasia, Anal cancer, Virus-like particle, Observation, CIN, Thigh, Human, HPV, Plant, Vaginal intraepithelial neoplasia, Nausea, MRK, VLP, Investment, Immunity, Fever, Erythema, Vaccination, Injury, Vaccine, Allergy, Itch, AIN, Swelling

Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.

Key Points: 
  • Separately, the company also plans to conduct clinical trials in both females and males to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 (Human Papillomavirus 9-valent, recombinant), compared to the approved three-dose regimen.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • The latest addition to the pipeline employs the company’s proprietary virus-like particle (VLP) technology to incorporate additional VLPs for expanded HPV type coverage.
  • These randomized, double-blind, multi-year clinical trials will examine the short and long-term efficacy and immunogenicity of a single-dose of GARDASIL 9 versus the currently approved three-dose regimen.

Willow Expands Its Retail Presence with Target to Prepare More Breastfeeding Moms for the Early Days of Feeding

Retrieved on: 
Tuesday, April 2, 2024
Silver, Lactation, Partnership, Education, SAN, Nipple, Milk, Breast, International Board, Target Corporation, Cracked, Nursing, Find, Swelling, Birth control

SAN FRANCISCO, April 2, 2024 /PRNewswire/ -- Willow Innovations, Inc. (Willow), the Femtech leader disrupting the breastfeeding and pumping industry, announced today its expanded presence in Target to provide solutions for moms' pressing feeding challenges. Willow's comprehensive system of breastfeeding products, including its award-winning pumps and on-the-go feeding accessories, will be available in Target stores nationwide and across its digital platforms.

Key Points: 
  • With its expanded presence, Willow launched an exclusive Find Your Flow Feeding Kit , offering moms breast care essentials to prevent and relieve common breastfeeding difficulties.
  • "Moms want to be successful at breastfeeding, and Willow is redefining what comprehensive support looks like for moms at this stage," said Sarah O'Leary, CEO of Willow Innovations.
  • It is the only breastfeeding kit that combines breast care solutions, virtual lactation consultancy, personalized feeding guidance, and digital feeding courses.
  • In addition to the exclusive Willow Find Your Flow Feeding Kit ($69.99), moms can shop the award-winning Willow 360™ and Willow Go ® wearable breast pumps and other feeding accessories at your local Target store, Target.com, and onewillow.com .

Study led by Akron Children's finds pro2cool's hypothermic therapy reduces adolescent concussion symptoms

Retrieved on: 
Tuesday, April 2, 2024
RN, Brain, Head, Medicine, Concussion, Ageing, Dayton Children's Hospital, Research, University, Doctor of Philosophy, University of Michigan, Frank R. McNinch, Adolescence, E pluribus unum, Hospital, Pain, Ice, Food, Swelling, FDA, Northeast Ohio Medical University, Parent, Neck, Sports medicine, Medical device

AKRON, Ohio, April 2, 2024 /PRNewswire/ -- Researchers at Akron Children's, Cincinnati Children's, University of Michigan and Dayton Children's Hospital, have found that hypothermic therapy reduces symptom severity after concussion.

Key Points: 
  • AKRON, Ohio, April 2, 2024 /PRNewswire/ -- Researchers at Akron Children's, Cincinnati Children's, University of Michigan and Dayton Children's Hospital, have found that hypothermic therapy reduces symptom severity after concussion.
  • After a second treatment using the pro2cool® system, SCAT5 scores were 25% lower than those receiving standard concussion care.
  • It is the first and only concussion treatment study of this population, and the largest single concussion therapy trial known to date.
  • Now, in addition to brain rest, concussion symptoms can be treated with selective hypothermic therapy.

Printed Electronics Converge: 3 Key Insights from IDTechEx at LOPEC 2024

Retrieved on: 
Wednesday, March 20, 2024
Players, Adhesive, Growth, Ink, Heat, Original equipment manufacturer, Health, Infection, Recycling, Stoma, Patient, Electronics, Research, Health care, Flexible, Electronic paper, BMW, Exhibition, Safety, LED, Swelling, Rehabilitation, Printed circuit board

BOSTON, March 20, 2024 /PRNewswire/ -- In March, the printed electronics industry flocked to Munich once again for the LOPEC 2024 conference and exhibition.

Key Points: 
  • BOSTON, March 20, 2024 /PRNewswire/ -- In March, the printed electronics industry flocked to Munich once again for the LOPEC 2024 conference and exhibition.
  • Printed electronics technology providers were, as usual, out in force to demonstrate their suitability to meet these challenges.
  • Leveraging established partnerships to build confidence and nurture interest from manufacturers was the focus of printed electronics technology companies at LOPEC 2024.
  • For more analysis on printed electronics technology, markets, and forecasts, see IDTechEx's dedicated reports on Printed and Flexible Sensors , Conductive Inks , and 3D Electronics .

Printed Electronics Converge: 3 Key Insights from IDTechEx at LOPEC 2024

Retrieved on: 
Wednesday, March 20, 2024
Players, Adhesive, Growth, Ink, Heat, Original equipment manufacturer, Health, Infection, Recycling, Stoma, Patient, Electronics, Research, Health care, Flexible, Electronic paper, BMW, Exhibition, Safety, LED, Swelling, Rehabilitation, Printed circuit board

BOSTON, March 20, 2024 /PRNewswire/ -- In March, the printed electronics industry flocked to Munich once again for the LOPEC 2024 conference and exhibition.

Key Points: 
  • BOSTON, March 20, 2024 /PRNewswire/ -- In March, the printed electronics industry flocked to Munich once again for the LOPEC 2024 conference and exhibition.
  • Printed electronics technology providers were, as usual, out in force to demonstrate their suitability to meet these challenges.
  • Leveraging established partnerships to build confidence and nurture interest from manufacturers was the focus of printed electronics technology companies at LOPEC 2024.
  • For more analysis on printed electronics technology, markets, and forecasts, see IDTechEx's dedicated reports on Printed and Flexible Sensors , Conductive Inks , and 3D Electronics .