Rash

Chromocell Issues Letter to Stockholders from Chief Executive Officer

Retrieved on: 
Tuesday, April 9, 2024
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We transferred $2.2 million in liabilities to Chromocell Corporation in exchange for 2,600 shares of Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”).

Key Points: 
  • We transferred $2.2 million in liabilities to Chromocell Corporation in exchange for 2,600 shares of Series C Convertible Redeemable Preferred Stock (“Series C Preferred Stock”).
  • Our CEO has agreed to further defer a considerable portion of his accrued compensation, affirming the belief in Chromocell’s mission.
  • We truly feel that our IPO and recent therapeutic development activities have positioned Chromocell for long term growth and success.
  • I wish to thank you for your support and remain a resource to each of you as we move forward.

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

Retrieved on: 
Sunday, April 7, 2024
Uric acid, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, Atherosclerosis, FAHA, Cleveland Clinic, Bempedoic acid, Ezetimibe, Therapy, Anemia, Pain, MACE, Sinusitis, ACC, FOMA, FNLA, FACC, Obesity, Cardiovascular disease, Esperion Therapeutics, Abdominal pain, Risk, Gout, Spasm, Woman, American College, Body mass index, ESPR, Back pain, Outcome, ATP, Safety, Fatigue, Arthralgia, ANN, Angioedema, Kidney, Journal, Constipation, University, Adverse event, Pregnancy, CLEAR, Rash, MPH, Rupture, FDA, Molina Healthcare, JACC, Hypersensitivity, Health, Circulatory system, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Dietary supplement

ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Phathom Pharmaceuticals Launches Direct-to-Consumer Campaign, “VOQUEZNA Can Kick Some Acid”

Retrieved on: 
Tuesday, March 26, 2024
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FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announces the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years.1

Key Points: 
  • The campaign will also be featured on consumer-facing platforms across Facebook, Instagram, waiting room TVs in doctor offices, and digital banner ads.
  • “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day.
  • To view a video of the “VOQUEZNA Can Kick Some Acid” commercial, click here.
  • Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.

argenx Announces Approval of VYVGART (efgartigimod alfa) in Japan for Adults with Primary Immune Thrombocytopenia

Retrieved on: 
Tuesday, March 26, 2024
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“argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.

Key Points: 
  • “argenx is on a mission to deliver transformative medicines for people living with severe autoimmune disease,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx.
  • By reducing circulating autoantibodies, VYVGART is uniquely designed to serve as a precision intervention that targets the underlying disease biology of ITP.
  • ADVANCE successfully met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo.
  • Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART.

Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid Treatment of dermatomyositis Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
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Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid Treatment of dermatomyositis Withdrawn

Key Points: 


Orphan designation: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid Treatment of dermatomyositis Withdrawn

U.S. FDA Approves Broad New Labels for NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Committee, Spasm, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Esperies, Rupture, FDA, Molina Healthcare, Hypersensitivity, Health, Conference, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Uric acid, Pharmaceutical industry

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • NEXLETOL and NEXLIZET are also the first oral non-statin LDL-C lowering drugs to be approved by the FDA to reduce the risk of CV events in both primary and secondary prevention patients.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

CHMP Issues Positive Opinions For Both Bempedoic Acid And The Bempedoic Acid / Ezetimibe Fixed-Dose Combination Tablet As Treatments For Hypercholesterolemia And Significantly Reducing Cardiovascular Events

Retrieved on: 
Friday, March 22, 2024
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ANN ARBOR, Mich. and MUNICH, Germany, March 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid (marketed as NILEMDO®▼) and the bempedoic acid / ezetimibe fixed dose combination (FDC) (marketed as NUSTENDI®▼ ), recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk.2 The existing label of bempedoic acid (NILEMDO®▼) provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2

Key Points: 
  • “We are thrilled with the positive CHMP opinion, which reflects the significant cardiovascular risk reduction benefit that the bempedoic acid global franchise brings to patients worldwide,” said Sheldon Koenig, President and CEO, Esperion.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • Hyperuricemia: Bempedoic acid, a component of NEXLIZET and NEXLETOL, may increase blood uric acid levels which may lead to gout.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Rate of national measles cases highlights importance of vaccination

Retrieved on: 
Thursday, March 21, 2024
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Nationally, the total number of measles cases has already reached the level that occurred during the entire year of 2023.

Key Points: 
  • Nationally, the total number of measles cases has already reached the level that occurred during the entire year of 2023.
  • Infants as young as 6 months can receive the first dose if traveling to areas where the measles infection rate is high.
  • Herd immunity, achieved through a measles vaccination rate of 95% or more, is crucial for preventing disease outbreaks in the community and protecting vulnerable populations who cannot receive vaccines.
  • The measles vaccine, given as part of the MMR (measles, mumps and rubella) vaccine, is extremely effective, giving those vaccinated with just one dose 93% protection against measles infection.

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.

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
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“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.