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Calliditas Announces Late-Breaking Presentations at the 60th European Renal Association (ERA) Congress 2023

Retrieved on: 
Freitag, Mai 5, 2023

STOCKHOLM, May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023.

Key Points: 
  • STOCKHOLM, May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023.
  • "We are delighted that these data presentations have been selected for the upcoming ERA Congress 2023 and extend our congratulations to all the authors involved.
  • Poster presentation details are below and will be available on the Investor page on the Calliditas' corporate website following the meeting.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.

Calliditas Announces Late-Breaking Presentations at the 60th European Renal Association (ERA) Congress 2023

Retrieved on: 
Freitag, Mai 5, 2023

STOCKHOLM, May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023.

Key Points: 
  • STOCKHOLM, May 5, 2023 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") announced upcoming data presentations from the NeflgArd Phase 3 Study at the European Renal Association (ERA) Congress 2023.
  • "We are delighted that these data presentations have been selected for the upcoming ERA Congress 2023 and extend our congratulations to all the authors involved.
  • Poster presentation details are below and will be available on the Investor page on the Calliditas' corporate website following the meeting.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.

Esperion Retains Gibson Dunn to Secure $300 Million Payment From DSE; Will Announce First Quarter Financial Results Tuesday, May 9

Retrieved on: 
Donnerstag, Mai 4, 2023

The complaint seeks a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to Esperion upon regulatory approval.

Key Points: 
  • The complaint seeks a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to Esperion upon regulatory approval.
  • “This amended complaint, filed by Gibson Dunn and supported by new evidence, makes clear that we are entitled to the $300 million milestone payment from DSE upon regulatory approval.
  • We will not acquiesce to DSE’s commercially dishonest tactics,” says Esperion President and Chief Executive Officer Sheldon Koenig.
  • “We are working diligently to resolve this dispute as we continue to commercialize bempedoic acid in Europe and around the world.

American Regent® Launches Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound)

Retrieved on: 
Dienstag, Mai 2, 2023

MELVILLE, N.Y., May 2, 2023 /PRNewswire/ -- American Regent, Inc.® is pleased to announce the launch of Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), which is an alternative to Abraxane®.

Key Points: 
  • Do not administer Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) to patients with baseline absolute neutrophil counts (ANC) of less than 1,500 cells/mm3.
  • In the case of severe neutropenia (
  • Permanently discontinue treatment with Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) and gemcitabine upon making a diagnosis of pneumonitis.
  • Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound) has different dosage and administration instructions from other paclitaxel products.

Watch out for dangerous combinations of over-the-counter cold medicine and prescription drugs – two pharmacoepidemiology experts explain the risks

Retrieved on: 
Freitag, April 21, 2023

When colds, flus and allergies hit, many people automatically turn to over-the-counter medications to push through and treat their symptoms.

Key Points: 
  • When colds, flus and allergies hit, many people automatically turn to over-the-counter medications to push through and treat their symptoms.
  • Nearly 70% of adults in the U.S. use over-the-counter medications as a first-line response for treating cold and flu symptoms.
  • We are a pharmacoepidemiologist and pharmacist team and we investigate adherence to medications and potential harms of medications associated with drug-drug interactions.
  • Another study estimated that every year, 26,735 people went to the emergency room for adverse events related to over-the-counter cold and cough medications.

The dangers of mixing medications

    • Pharmacists and physicians are typically knowledgeable about potential drug interactions, so it is very important for patients to ask their health care providers which over-the-counter medications are safe for them to use.
    • It is important to read the package ingredients of over-the-counter medications closely to avoid duplication of doses.
    • Cold medications are typically made up of multiple ingredients, including pain relievers, nasal decongestants and cough suppressants or expectorants.
    • Combining these decongestants with monoaminooxidase inhibitors or tricyclic antidepressants could lead to very high blood pressure and heart rhythm problems.

Each person responds to drugs differently

    • As we age, our bodies begin to lose the ability to efficiently clear drugs, which increases the risk of adverse events and unintentional overdoses.
    • Some drugs can be dangerous for people who have particular health conditions.
    • In addition, since these drugs are associated with increased blood pressure, patients with hypertension, hyperthyroidism or heart disease should be careful when using them, or avoid them altogether.

Alternatives for children

    • The Food and Drug Administration and the Centers for Disease Control and Prevention do not recommend giving cold medications to children under age 4.
    • Because of a variety of factors, young children have a higher risk of accidental overdose and adverse events that could lead to death.
    • Research has shown that honey can be helpful for reducing cold and flu symptoms in children older than age 1.

Pregnancy best practices

    • Acetaminophen is the doctor-recommended over-the-counter medication for management of pain and fever at any stage of pregnancy.
    • Any other pain relievers or anti-inflammatory medicine such as ibuprofen, ketoprofen, naproxen and aspirin should not be taken during pregnancy without a doctor’s approval.
    • For symptoms such as nasal congestion during pregnancy, a decongestant called oxymetazoline in its intranasal form is the drug of choice.

Bausch + Lomb Announces the Presentation of New Data on Products and Pipeline Programs at the Association for Research in Vision and Ophthalmology Meeting

Retrieved on: 
Donnerstag, April 20, 2023

“Comparative Evaluation of the Attributes of a New Cohesive Ophthalmic Viscosurgical Device.” Hosten et al.

Key Points: 
  • “Comparative Evaluation of the Attributes of a New Cohesive Ophthalmic Viscosurgical Device.” Hosten et al.
  • “Early Adoption of Triamcinolone Acetonide Suprachoroidal Injection for Uveitic Macular Edema: A Physician Survey.” Chang et al.
  • “Longitudinal Analysis of In Vitro Antibiotic Resistance Among Ocular Staphylococci Collected in the ARMOR study.” Asbell et al.
  • To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

Calliditas Announces Publication of Cost-Effectiveness Analysis of Nefecon versus Best Supportive Care for People with IgA Nephropathy in the United States

Retrieved on: 
Dienstag, April 11, 2023

NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced the publication of a cost-effective analysis of Nefecon (marketed in the United States as TARPEYO® (budesonide) delayed release capsules) versus standard of care (SOC) for people with Primary IgA Nephropathy (IgAN) in the United States (US).

Key Points: 
  • NEW YORK, April 11, 2023 (GLOBE NEWSWIRE) -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”), announced the publication of a cost-effective analysis of Nefecon (marketed in the United States as TARPEYO® (budesonide) delayed release capsules) versus standard of care (SOC) for people with Primary IgA Nephropathy (IgAN) in the United States (US).
  • Health-state occupancy probabilities and key model inputs were based on the individual patient-level data from NefIgArd, the Phase 3 randomized controlled trial evaluating Nefecon.
  • Andrew Udell, president, North America at Calliditas stated: “These findings are timely and relevant in light of the 2-year eGFR results from the NefIgArd trial we recently announced.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.

Preclinical Data on the Potential of Byondis ADC BYON3521 Published in Molecular Cancer Therapeutics

Retrieved on: 
Mittwoch, April 12, 2023

NIJMEGEN, Netherlands, April 12, 2023 /PRNewswire/ -- Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, today announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521.

Key Points: 
  • NIJMEGEN, Netherlands, April 12, 2023 /PRNewswire/ -- Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, today announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521.
  • The article, "Preclinical profile of BYON3521 predicts an effective and safe c-MET-antibody-drug conjugate," suggests that BYON3521 has an encouraging safety/efficacy window with potential for clinical benefit in patients.
  • The data from in vitro and in vivo studies showed that BYON3521 potently and selectively kills tumor cells expressing c-MET, even at low c-MET-expressing levels.
  • The antibody part of BYON3521 binds to c-MET on the surface of the cancer cell and the ADC is internalized.

Preclinical Data on the Potential of Byondis ADC BYON3521 Published in Molecular Cancer Therapeutics

Retrieved on: 
Mittwoch, April 12, 2023

NIJMEGEN, Netherlands, April 12, 2023 /PRNewswire/ -- Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, today announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521.

Key Points: 
  • NIJMEGEN, Netherlands, April 12, 2023 /PRNewswire/ -- Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, today announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521.
  • The article, "Preclinical profile of BYON3521 predicts an effective and safe c-MET-antibody-drug conjugate," suggests that BYON3521 has an encouraging safety/efficacy window with potential for clinical benefit in patients.
  • The data from in vitro and in vivo studies showed that BYON3521 potently and selectively kills tumor cells expressing c-MET, even at low c-MET-expressing levels.
  • The antibody part of BYON3521 binds to c-MET on the surface of the cancer cell and the ADC is internalized.

Preclinical Data on the Potential of Byondis ADC BYON3521 Published in Molecular Cancer Therapeutics

Retrieved on: 
Mittwoch, April 12, 2023

NIJMEGEN, Netherlands, April 12, 2023 /PRNewswire/ -- Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, today announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521.

Key Points: 
  • NIJMEGEN, Netherlands, April 12, 2023 /PRNewswire/ -- Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, today announced that Molecular Cancer Therapeutics (an American Association for Cancer Research journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521.
  • The article, "Preclinical profile of BYON3521 predicts an effective and safe c-MET-antibody-drug conjugate," suggests that BYON3521 has an encouraging safety/efficacy window with potential for clinical benefit in patients.
  • The data from in vitro and in vivo studies showed that BYON3521 potently and selectively kills tumor cells expressing c-MET, even at low c-MET-expressing levels.
  • The antibody part of BYON3521 binds to c-MET on the surface of the cancer cell and the ADC is internalized.