Fever

Revive Therapeutics To Submit Type C Meeting Request with FDA for Bucillamine to Treat Long COVID

Retrieved on: 
Tuesday, March 19, 2024
COVID, Type, COVID-19, Patient, Heart rate, Research, RVV, Death, Doctor of Philosophy, Trial of the century, Cough, CDC, Harvard University, Fever, Safety, Therapy, Disorder, FDA, Economics, Hospital, Pharmaceutical industry

The Company expects to submit the Type C meeting request by next week.

Key Points: 
  • The Company expects to submit the Type C meeting request by next week.
  • The CDC estimates that 7.5 percent of U.S. adults have long COVID symptoms1.
  • David Cutler, PhD, a professor of economics at Harvard University, estimates in a recent research disclosure that the total economic cost of long COVID could be as much as $3.7 trillion2.
  • Currently, the Company is exploring the use of Bucillamine as a potential treatment for long COVID.

SPEVIGO® approved for expanded indications in China and the US

Retrieved on: 
Tuesday, March 19, 2024
Arthralgia, Urinary tract infection, Uncertainty, Human, NMPA, Psoriasis, Disease, Multiple organ dysfunction syndrome, Incidence, Risk, GPP, Boehringer Ingelheim, Patient, Ageing, Executive officer, Immunoglobulin G, Anxiety, Doctor of Philosophy, MD, Quality of life, Flare, Injection site reaction, Clinical trial, Skin, Fever, Immune system, Pain, Itch, Food, FDA, Yale University, Fear

In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.

Key Points: 
  • In the trial with 123 patients, no flares were observed after week 4 of SPEVIGO® subcutaneous treatment in the high-dose group (n=30).13,14,15,16 In the Effisayil® 2 trial, SPEVIGO® was associated with an increased incidence (≥9 cases per 100 patient-years) of injection site reaction, urinary tract infection, arthralgia, and pruritus compared to placebo.
  • “Until now, people living with GPP have not had any approved options to treat their disease,” said Bruce Strober, MD, PhD, Clinical Professor, Dermatology, Yale University and Central Connecticut Dermatology.
  • “Experiencing GPP can be mentally and physically devastating, leaving those affected with uncertainty and fear of the next episode.
  • Therefore, expanding the treatment of GPP is a critical step towards addressing patients’ needs.”

Orchard Therapeutics Receives FDA Approval of Lenmeldy™ (atidarsagene autotemcel), the Only Therapy for Eligible Children with Early-onset Metachromatic Leukodystrophy in the U.S.

Retrieved on: 
Monday, March 18, 2024
Gastroenteritis, Genomics, Metabolism, Neutropenia, Brain, Nerve, Mutation, RPD, Disease, Incidence, Partnership, Central nervous system, Genetics, GSK, Stomatitis, Patient, Research, Fats, PRV, Traffic barrier, Child, Viral, Gene therapy, SAN, Genome, Urinary tract infection, Rash, Hepatomegaly, Priority review, Stem cell, Infection, Therapy, MLD, Kyowa Kirin, Febrile neutropenia, Fever, PSLI, Prognosis, Health, Family, FDA, San Raffaele Hospital, ARSA, Orchard, Food, Pharmaceutical industry

“MLD is a rapidly progressing, life-limiting and ultimately fatal rare disease that has a devastating impact on afflicted children and their families.

Key Points: 
  • “MLD is a rapidly progressing, life-limiting and ultimately fatal rare disease that has a devastating impact on afflicted children and their families.
  • This achievement is the culmination of decades of research and development in partnership with our academic and clinical collaborators at the San Raffaele-Telethon Institute for Gene Therapy.
  • It was previously given both Rare Pediatric Disease (RPD) and Regenerative Medicine Advanced Therapy (RMAT) designations from FDA.
  • Orchard Therapeutics will provide more details about the launch of Lenmeldy in the U.S. through a separate announcement this week.

Revive Therapeutics Provides Corporate Update

Retrieved on: 
Tuesday, March 12, 2024
DRDC, Neuroprotection, Tremor, Diazepam, Chronic pain, COVID, Soman, National security, Survival, NAC, Seizure, Partnership, Nervous system, VX, COVID-19, Nerve agent, Patient, Brain, Heart rate, Research, Diarrhea, Endocytosis, RVV, Death, Doctor of Philosophy, Health Canada, Trial of the century, Cough, Traumatic brain injury, CDC, Harvard University, Fever, Sarin, Bleeding, Safety, Chemical warfare, Saliva, Therapy, Disorder, Blurred vision, FDA, Economics, Nerve, Hospital, Pharmaceutical industry

TORONTO, March 12, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today a corporate update on the research, clinical and regulatory initiatives with Bucillamine and its long COVID diagnostic product.

Key Points: 
  • TORONTO, March 12, 2024 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, announced today a corporate update on the research, clinical and regulatory initiatives with Bucillamine and its long COVID diagnostic product.
  • Exposure to nerve agents can cause tightness of the chest, excessive salivation, abdominal cramps, diarrhea, blurred vision, tremors, and death.
  • In addition, Revive may evaluate the potential of its proposed long COVID diagnostic product as a companion to Bucillamine.
  • The Company, under its wholly-owned subsidiary Revive Diagnostics Inc., is advancing the product development of a potential blood biomarker diagnostic that characterizes long COVID.

ŌURA Introduces Oura Labs, A New In-App Innovation Hub for Members

Retrieved on: 
Wednesday, April 3, 2024
Wearables, Mobile Technology, Apps, Applications, Technology, Health Technology, Software, Hardware, Health, General Health, Data Management, Temperature, Respiratory rate, Heart rate, Oura Health, Public, Oura, Heel, Research, Sleep, Rest, University, Marketing, Radar, Fever, Citizen science, Fatigue, IOS, Feedback

ŌURA, maker of Oura Ring, the most accurate and trusted smart ring, today announced the launch of a new in-app platform, Oura Labs.

Key Points: 
  • ŌURA, maker of Oura Ring, the most accurate and trusted smart ring, today announced the launch of a new in-app platform, Oura Labs.
  • The latest addition to the Oura Membership experience is designed to accelerate innovation by bringing members into the research and development process.
  • Now, they will have the opportunity to opt-in to test experimental features, provide feedback, and contribute to discussions about Oura and the future of wearable technology.
  • Oura Members will also be able to participate in innovative research studies conducted by internal Oura teams, including Science, Product, and Marketing, as well as studies conducted in collaboration with partner organizations and academic institutions.

VOYDEYA™ approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular hemolysis in adults with the rare disease PNH

Retrieved on: 
Monday, April 1, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Factor D, Arthralgia, Chest pain, Confusion, Neuropsychological test, Infection, Eculizumab, Risk, Headache, ALPHA, PNH, C5, Patient, Orphan, Mitigation, Vaccine, Light, Paroxysmal nocturnal hemoglobinuria, EVH, Bacteria, University, Chills, MD, Breakthrough therapy, Cough, European Medicines Agency, Fatigue, Nausea, Rash, Fever, Priority, Safety, Immune system, REMS, Division, Vomiting, Hematology, Patient safety, Medicine

VOYDEYA has also been granted Orphan Drug Designation in the US, European Union (EU) and Japan for the treatment of PNH.

Key Points: 
  • VOYDEYA has also been granted Orphan Drug Designation in the US, European Union (EU) and Japan for the treatment of PNH.
  • You must complete or update meningococcal vaccine(s) and streptococcus vaccine(s) at least 2 weeks before your first dose of VOYDEYA.
  • If you have been vaccinated against these bacteria in the past, you might need additional vaccinations before starting VOYDEYA.
  • Carry it with you at all times during treatment and for 1 week after your last VOYDEYA dose.

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.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

NEW REPORT SUPPORTS USE OF CALDOLOR® AS A STANDARD OF CARE ACROSS PATIENT POPULATIONS

Retrieved on: 
Tuesday, April 2, 2024
Perioperative medicine, Database, Pain, Patient, Anesthesiology, City, News, Pain management, General surgery, Fever, Safety, NSAID

NASHVILLE, Tenn., April 2, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced the release of a Special Report evaluating the growing amount of current data supporting the use of its Caldolor® product (intravenous ibuprofen, or IVIB) as a standard of care for the treatment of pain and fever in adults, children and infants.

Key Points: 
  • As part of a comprehensive safety and efficacy developmental plan, IVIB was studied in various treatment areas, including surgical pain, fever and nonsurgical acute pain.
  • IVIB is the only non-opioid injectable analgesic approved for use in children as young as 3 months of age.
  • "Pain management has become one of the most common health care problems," said A.J.
  • "As this new report states, comprehensive multimodal pain regimens have become key in preventing pain and optimizing pain control, while minimizing the need for opioids.

ACR Poker Sets Up Action-Packed April Leading to the $12.5 Million Venom

Retrieved on: 
Tuesday, April 2, 2024
GTD, SAN, ACR, Intel Turbo Boost, Heat, World Series, Fever

Chris Moneymaker, World Series of Poker champion and ACR Pro, shared his excitement about the upcoming events, "April's going to be insane over at ACR.

Key Points: 
  • Chris Moneymaker, World Series of Poker champion and ACR Pro, shared his excitement about the upcoming events, "April's going to be insane over at ACR.
  • I've played in my fair share of big stakes games, but the $12.5 million Venom ?
  • While the $12.5 million Venom tournament may be the headline act, ACR Poker is running Venom Specials on Day 1A, 1B, 1C, 1D, and 1E plus Day 2 of the Venom.
  • For additional details on the Venom tournament and all the scheduled April promotions at ACR Poker, visit acrpoker.eu.