Itch

Mirum Pharmaceuticals’ LIVMARLI (maralixibat oral solution) Receives Positive Reimbursement Recommendation by Canada’s CADTH for Patients with Cholestatic Pruritus in Alagille Syndrome

Retrieved on: 
Tuesday, April 2, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Itch, Medication, Alagille syndrome, Liver disease, Inflammation, Patient, Cholestasis, Bile, Cholestatic pruritus, CADTH, Liver injury, The Hospital, Liver, CDEC, Genetic disorder, PFIC, Pharmaceutical industry

“The positive reimbursement recommendation for LIVMARLI by CADTH is an important step forward for patients suffering from the debilitating effects of cholestatic pruritus related to Alagille syndrome,” said Chris Peetz, chief executive officer at Mirum.

Key Points: 
  • “The positive reimbursement recommendation for LIVMARLI by CADTH is an important step forward for patients suffering from the debilitating effects of cholestatic pruritus related to Alagille syndrome,” said Chris Peetz, chief executive officer at Mirum.
  • These patients suffer greatly from the debilitating and disruptive effects of Alagille syndrome, which often starts in early childhood.”
    “CADTH’s recommendation of reimbursement for LIVMARLI provides a meaningful advancement in the treatment of cholestatic pruritus for patients with Alagille syndrome.
  • LIVMARLI is also approved for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) in the U.S. and Europe, and for Progressive Familial Intrahepatic Cholestasis (PFIC) in the U.S. and in Europe.
  • Cholestasis in ALGS is associated with pruritus which is among the most common indications for liver transplant in ALGS.

Takeda Announces Approval of ADZYNMA® Intravenous Injection 1500 (apadamtase alfa /cinaxadamtase alfa) in Japan for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

Retrieved on: 
Tuesday, March 26, 2024
Health, General Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Microangiopathic hemolytic anemia, Incidence, Headache, Patient, Thrombotic thrombocytopenic purpura, Constipation, Mortality, Head, TTP, Nausea, Toll, Heart, Safety, Itch, Thrombocytopenia, Hypertension, Pharmaceutical industry

Takeda ( TSE: 4502/NYSE:TAK ) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa /cinaxadamtase alfa) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older.1 ADZYNMA is the first and only approved recombinant ADAMTS13 protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme.

Key Points: 
  • Takeda ( TSE: 4502/NYSE:TAK ) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa /cinaxadamtase alfa) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older.1 ADZYNMA is the first and only approved recombinant ADAMTS13 protein designed to address an unmet medical need in people with cTTP by replacing the deficient ADAMTS13 enzyme.
  • cTTP is an ultra-rare, chronic blood clotting disorder caused by a deficiency in the ADAMTS13 enzyme.2 It is associated with acute events and debilitating chronic symptoms or thrombotic thrombocytopenic purpura (TTP) manifestations, which can include thrombocytopenia, microangiopathic hemolytic anemia, headache and abdominal pain.2,3,4 When left untreated, acute TTP events have a mortality rate of >90%.2,4
    “The approval of ADZYNMA is an important milestone for people living with cTTP in Japan, who had limited treatment options and now have the first treatment option specifically approved to treat this ultra-rare condition,” said Yasushi Kajii, Head, R&D Japan Region at Takeda.
  • “Developing innovative treatments that make a difference in the lives of patients is at the heart of what we do.
  • In Period 3, the incidence of TEAEs was 2.8% (1/36) in this drug group: nausea and headache (1 subject each).6
    This approval does not result in any changes to Takeda’s consolidated forecast for the fiscal year ending March 31, 2024 (FY2023).

Gilead Sciences Announces Completion of Acquisition of CymaBay

Retrieved on: 
Friday, March 22, 2024
Health, Hospitals, General Health, Research, Science, Pharmaceutical, Biotechnology, EPS, Patient, Gilead Sciences, Acquisition, Primary biliary cholangitis, PBC, Therapy, Safety, Itch, Pharmaceutical industry

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for approximately $4.3 billion in total equity value.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced the completion of the previously announced transaction to acquire CymaBay Therapeutics, Inc. (Nasdaq: CBAY) for approximately $4.3 billion in total equity value.
  • “The acquisition of CymaBay brings us a potential best in disease therapy that could transform the treatment landscape for people with primary biliary cholangitis,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.
  • “I want to thank the CymaBay team for their efforts and commitment to addressing this high unmet need.
  • Pursuant to the merger agreement, Gilead and Purchaser commenced a tender offer on February 23, 2024, to acquire all outstanding shares of CymaBay at a price of $32.50 per share.

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.

Mirum Pharmaceuticals’ LIVMARLI Receives FDA Approval for Treatment of Cholestatic Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis

Retrieved on: 
Wednesday, March 13, 2024
Health, FDA, Infectious Diseases, General Health, Clinical Trials, Pharmaceutical, Biotechnology, Growth, Medication, Alagille syndrome, Disease, Patient, Shanda, Sleep, ALGS, Cholestatic pruritus, Quality of life, Life, Cholestasis, Multimedia, Itch, Collection, Family, Food, Pharmaceutical industry

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC).

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients five years of age and older with progressive familial intrahepatic cholestasis (PFIC).
  • View the full release here: https://www.businesswire.com/news/home/20240313135184/en/
    LIVMARLI® (maralixibat) oral solution is now available for prescribing in the US for cholestatic pruritus in patients with PFIC.
  • “LIVMARLI has the potential to have a transformational impact for patients with cholestatic pruritus associated with PFIC, and importantly, offers an option for those patients with the rarest of subtypes,” said Chris Peetz, chief executive officer at Mirum.
  • We are hopeful that LIVMARLI will have a measurable impact for patients, potentially offering a new normal and relief from the sleepless nights and disruption to their lives caused by cholestatic pruritus.”

Kidney Patients Raise National Health Alert on Phosphorus

Retrieved on: 
Thursday, April 4, 2024
Hyperphosphatemia, Transplant, Nutrient, Hyperkalemia, Congress, Patient, Stroke, Social media, Investment, United States Senate, Phosphorus, Representative, Ways and means committee, Research, Education, Itch, Risk, ESRD, Policy, FMLA, CMS, Senate, Food, Federation, Kidney failure, Prospective payment system, Death, House, Executive (government), Louisiana House of Representatives, Graduate diploma, Dialysis, FDA, Government, Seizure, CKD, Mortality, Kidney disease, Medicare, Physician, Pharmaceutical industry

WASHINGTON, April 4, 2024 /PRNewswire/ -- The American Association of Kidney Patients (AAKP), the oldest and largest independent kidney patient consumer organization in the U.S., is raising public awareness on April 5, National Phosphorus Awareness Day, about the devastating impacts of unmanaged phosphorus levels in individuals with advanced chronic kidney disease (CKD).

Key Points: 
  • Kidney patients are at an increased risk for high phosphorus (termed hyperphosphatemia) due to their decreased kidney function and an inability to excrete excess nutrients, including phosphorus.
  • Kidney patients are medically complex and typically manage multiple co-related health conditions including hyperphosphatemia , hyperkalemia , CKD associated pruritis (CKD-aP) , and more .
  • Kidney patients and all people of goodwill involved in the fight to improve kidney health are making their voices heard by contacting their U.S.
  • Since 1969, The American Association of Kidney Patients has been a patient-led organization driving policy discussions on kidney patient care choice and medical innovation.

Tired Legs? No Problem for PLAMECA!

Retrieved on: 
Wednesday, March 27, 2024
System, Weight gain, Inflammation, Twitch, Mayo Clinic, Restless legs syndrome, Sleep, Rest, Meal, Quality of life, Itch, Glass, Woman, Restless, Hesperidin, Water, Weather, Dietary supplement

FORT LAUDERDALE, Fla., March 27, 2024 /PRNewswire/ -- Tired legs syndrome is a common issue for many individuals. The restless, twitching symptoms can be distracting and uncomfortable and ultimately impact quality of life. PLAMECA's VENALIGHT PLUS CAPSULES were designed to restore circulation in the legs and eliminate the issue of restless legs.

Key Points: 
  • PLAMECA's VENALIGHT PLUS CAPSULES were designed to restore circulation in the legs and eliminate the issue of restless legs.
  • Also called Restless Legs Syndrome, tired legs is a health condition that occurs when an individual feels a sudden urge to move their legs while in a resting position.
  • "VENALIGHT PLUS is ideal for the treatment and prevention of tired legs," says PLAMECA's managing director, Óscar Fernández.
  • Tired legs are a common issue for many individuals, whether they develop due to warm weather, excessive weight gain, or simply standing for too long.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
Tuesday, March 26, 2024
Ulcer, Myocardial infarction, Liver disease, Endo International, Hyperkalemia, Horizon Therapeutics, Patient, Stroke, History, Aspirin, CABG, Pain, Famotidine, Itch, NSAID, Stomach, Central nervous system, Edema, ACE, Risk, CNS, Perforation, Peptic ulcer disease, Heart failure, Anaphylaxis, Amgen, Fatigue, Hypertension, Delirium, Kidney, Coma, Tablet, Eosinophilia, Nonsteroidal anti-inflammatory drug, Senior, Rash, Lethargy, OTC, Creatinine, Hepatotoxicity, Ibuprofen, Hypersensitivity, Esophagus, Jaundice, Rheumatoid arthritis, Water retention, Seizure, Incidence, Gastrointestinal bleeding, Inflammation, Extrapyramidal system, Ischemia, Diarrhea, GI, Nausea, Diuretic, Bleeding, NSAIDS, Physician, Osteoarthritis, Pharmaceutical industry

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Endo Launches Ibuprofen-Famotidine Tablets, Generic Version of DUEXIS®

Retrieved on: 
Tuesday, March 26, 2024
Ulcer, Myocardial infarction, Liver disease, Endo International, Hyperkalemia, Horizon Therapeutics, Patient, Stroke, History, Aspirin, CABG, Pain, Famotidine, Itch, NSAID, Stomach, Central nervous system, Edema, ACE, Risk, CNS, Perforation, Peptic ulcer disease, Heart failure, Anaphylaxis, Amgen, Fatigue, Hypertension, Delirium, Kidney, Coma, Tablet, Eosinophilia, Nonsteroidal anti-inflammatory drug, Senior, Rash, Lethargy, OTC, Creatinine, Hepatotoxicity, Ibuprofen, Hypersensitivity, Esophagus, Jaundice, Rheumatoid arthritis, Water retention, Seizure, Incidence, Gastrointestinal bleeding, Inflammation, Extrapyramidal system, Ischemia, Diarrhea, GI, Nausea, Diuretic, Bleeding, NSAIDS, Physician, Osteoarthritis, Pharmaceutical industry

DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.

Key Points: 
  • DUBLIN, March 26, 2024 /PRNewswire/ -- Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., launched ibuprofen-famotidine 800 mg/26.6 mg tablets, a generic version of Amgen's (formerly Horizon Therapeutics) DUEXIS®.
  • Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
  • Ibuprofen and famotidine tablets should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
  • If ibuprofen and famotidine is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

KINDRA LAUNCHES FIRST-EVER COMPREHENSIVE VAGINAL HEALTH SYSTEM: THE DAILY V SYSTEM

Retrieved on: 
Monday, March 25, 2024
DPT, Testosterone, Sulfate, Urology, Hormone, Hyaluronic acid, Woman, Vaginal lubrication, FACOG, Libido, Arousal, Paraben, Dry, MD, Itch, Vaginitis, WCS, Skin, Pelvic floor, Stinger, Irritation, Medicine, Personal lubricant, Pain, BCB-PMD, Orgasm, Birth control

NEW YORK, March 25, 2024 /PRNewswire/ -- Today, Kindra, the sex-positive vaginal health brand, announced the launch of the first-ever comprehensive vaginal health product system - the Daily V System. The 4-part daily regimen of Kindra products includes: Daily Vaginal Lotion, V Relief Serum, Soothe Bath Soak and the Core Supplement meant to support vulvar and vaginal skin for optimal vaginal health and sexual wellness.

Key Points: 
  • NEW YORK, March 25, 2024 /PRNewswire/ -- Today, Kindra , the sex-positive vaginal health brand, announced the launch of the first-ever comprehensive vaginal health product system - the Daily V System .
  • The 4-part daily regimen of Kindra products includes: Daily Vaginal Lotion , V Relief Serum , Soothe Bath Soak and the Core Supplement meant to support vulvar and vaginal skin for optimal vaginal health and sexual wellness.
  • This hormone-free system is designed to provide targeted relief and support for daily vulvar and vaginal health needs.
  • As part of its launch of the Daily V System, Kindra has partnered with pelvic floor physical therapist Dr. Sara Reardon, known online as The Vagina Whisperer, on a video about the importance of a daily vaginal health regimen for long-term vulvovaginal health and comfort.