Eosinophilia

NIMML Institute Presents Pioneering Research on Immunometabolic Mechanisms Related to the Pharmacological Activation of LANCL Receptors at Immunology2024, the Annual Meeting of the American Association of Immunologists

Retrieved on: 
Wednesday, April 10, 2024

The AAI meeting will take place at McCormick Place in Chicago, Illinois from May 3 to May 7, 2024.

Key Points: 
  • The AAI meeting will take place at McCormick Place in Chicago, Illinois from May 3 to May 7, 2024.
  • “We are pleased to present our most recent findings related to the immunometabolic mechanisms of activation of LANCL receptors in inflammation & immunology at this year’s AAI Annual Meeting,” said Dr. Josep Bassaganya-Riera, President and Founding Director of NIMML.
  • NImmune’s portfolio includes first and best-in-class omilancor and NIM-1324, two oral, once-daily agonistic therapeutics that bind and activate the LANCL2 pathway.
  • Title: Pharmacological activation of LANCL2 provides immunometabolic support for the restoration of cognitive function markers in a mouse model of Alzheimer’s disease.

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

Retrieved on: 
Tuesday, March 26, 2024

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

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.

Aucta Pharmaceuticals, Inc. ("Aucta Pharmaceuticals") launches MOTPOLY XR™ (lacosamide) extended-release capsules C-V, the first, and only once-daily formulation of lacosamide

Retrieved on: 
Monday, February 26, 2024

MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.

Key Points: 
  • MOTPOLY XR is approved for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg.
  • MOTPOLY XR is bioequivalent to Vimpat® (lacosamide) film-coated tablets, C-V and provides a new once-daily option at equivalent doses.
  • "MOTPOLY XR marks a major milestone for Aucta as our 1st branded pharmaceutical product to enter the US market.
  • To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Dupixent® (dupilumab) U.S. Label Updated with Data Further Supporting Use in Atopic Dermatitis with Moderate-to-Severe Hand and Foot Involvement

Retrieved on: 
Tuesday, January 16, 2024

TARRYTOWN, N.Y. and PARIS, Jan. 16, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has updated the label for Dupixent® (dupilumab) in atopic dermatitis, adding efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement. These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.

Key Points: 
  • These Phase 3 data are from the first and only trial evaluating a biologic specifically for this difficult-to-treat population and have also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.
  • “Having these data added for this difficult-to-treat population is important for physicians looking for tools to treat these patients and reinforces the already well-established efficacy and safety of Dupixent in atopic dermatitis overall.”
    The label update is based on data from the Phase 3 LIBERTY-AD-HAFT trial.
  • In the trial, patients received Dupixent (n=67) every two weeks (adults 300 mg, adolescents 200 mg or 300 mg based on body weight) or placebo (n=66).
  • Most common adverse events (AEs) observed with Dupixent (≥1%) in atopic dermatitis include injection site reactions, conjunctivitis, blepharitis, oral herpes, keratitis, eye pruritus, other herpes simplex virus infection, dry eye and eosinophilia.

KAZIA ANNOUNCES THE RELEASE OF PNOC022 CLINICAL STUDY ABSTRACT HIGHLIGHTING PAXALISIB IN DIFFUSE MIDLINE GLIOMA PATIENTS AHEAD OF THE SOCIETY OF NEURO-ONCOLOGY 2023 ANNUAL MEETING

Retrieved on: 
Wednesday, November 15, 2023

The preliminary results from a single cohort in this Pacific Pediatric Neuro-Oncology Consortium (PNOC) sponsored cooperative group clinical study will be presented on Sunday, 19 November 2023 in Vancouver, Canada.

Key Points: 
  • The preliminary results from a single cohort in this Pacific Pediatric Neuro-Oncology Consortium (PNOC) sponsored cooperative group clinical study will be presented on Sunday, 19 November 2023 in Vancouver, Canada.
  • Sixty-eight children and young adults with DMG who completed standard of care radiation treatment received paxalisib (an investigational PI3K-mTOR dual inhibitor) and ONC201 (an investigational dopamine receptor D2 (DRD2) and ClpP agonist).
  • The abstract reported that median overall survival (OS) from time of diagnosis was 16.5 months.
  • "The PNOC022 study has exceeded expectations in terms of enrolment rates and has partnered with 29 leading children's cancer centers and physicians across the globe."

DRESS Smarter: Bridging the Gap in Severe Drug Reactions

Retrieved on: 
Wednesday, July 12, 2023

RICHMOND, Va., July 12, 2023 /PRNewswire-PRWeb/ -- Around the world, millions of people suffer from severe adverse drug reactions, many of which do not get proper funding or research. For patients with DRESS Syndrome, the experience can be isolating. However, a nonprofit behind National DRESS Syndrome Day is providing a platform for building awareness of this debilitating life threatening condition. On July 16, 2023, the DRESS Syndrome Foundation will encourage patients and medical communities to unite over this year's theme: "DRESS/smarter." By recognizing positive advancements in DRESS Syndrome, the holiday gives a voice to this uncommon but life-threatening reaction, and supports research efforts that bridge the gap worldwide.

Key Points: 
  • A national holiday with a global reach, DRESS Syndrome Day highlights progress and future insights into severe adverse drug reactions.
  • "There is still so much we don't understand about this severe and potentially fatal drug reaction," explains Tasha Tolliver, Executive Director and Co-Founder of DRESS Syndrome Foundation.
  • Additionally, Dr. Korman's team identified a unique "earlobe crease sign" that distinguishes DRESS from other severe adverse drug reactions, facilitating faster and more accurate diagnosis.
  • "We founded the DRESS Syndrome Foundation to fill a much-needed gap in patient advocacy, a gap that today would have saved our daughters lives," says Nancy Szakacsy, Co-Founder of DRESS Syndrome Foundation.

Dupixent® (dupilumab) Approved by European Commission as First and Only Targeted Medicine for Children as Young as Six Months Old with Severe Atopic Dermatitis

Retrieved on: 
Tuesday, March 21, 2023

TARRYTOWN, N.Y. and PARIS, March 21, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. With this approval, Dupixent is the first and only targeted medicine indicated to treat these young children in Europe and the U.S.

Key Points: 
  • “I’ve personally witnessed how this chronic skin disease can disrupt the lives of entire families when left uncontrolled.
  • Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood.
  • Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers.
  • “Too often the parents and caregivers of children with severe atopic dermatitis are left desperate for new treatments to manage this chronic disease.

Press Release: Dupixent® (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis 

Retrieved on: 
Tuesday, March 21, 2023

The European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.

Key Points: 
  • The European Commission (EC) has approved Dupixent® (dupilumab) in the European Union (EU) to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy.
  • Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers.
  • With this latest approval, Dupixent is the first-ever biologic medicine for people living with atopic dermatitis from infancy to adulthood.
  • Too often the parents and caregivers of children with severe atopic dermatitis are left desperate for new treatments to manage this chronic disease.

Dupixent® (dupilumab) Approved by European Commission as the First and Only Targeted Medicine Indicated for Eosinophilic Esophagitis

Retrieved on: 
Monday, January 30, 2023

TARRYTOWN, N.Y. and PARIS, Jan. 30, 2023 (GLOBE NEWSWIRE) --  Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Commission (EC) expanded the marketing authorization for Dupixent® (dupilumab) in the European Union (EU) to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly. With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.

Key Points: 
  • EoE is a chronic, progressive inflammatory disease that damages the esophagus and prevents it from working properly.
  • With this approval, Dupixent is the first and only targeted medicine specifically indicated to treat EoE in Europe and the U.S.
    “This latest approval establishes Dupixent as the only targeted medicine specifically indicated for eosinophilic esophagitis in the European Union.
  • “Since its first approval, Dupixent has redefined the treatment of certain chronic diseases with underlying type 2 inflammation and is now indicated for five conditions in the European Union.
  • The safety results of the trial were generally consistent with the known safety profile of Dupixent in its approved indications.