Hypokalemia

AstraZeneca caps patient out-of-pocket costs at $35 per month for its US inhaled respiratory portfolio

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Monday, March 18, 2024
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AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.

Key Points: 
  • AstraZeneca announced it will expand the savings programs for its entire US inhaled respiratory portfolio, helping eligible patients pay no more than $35 per month for their medicine.
  • We remain dedicated to addressing the need for affordability of our medicines, but the system is complex and we cannot do it alone.
  • The Company will continue to provide discounts and rebates off the list price to help patients afford its inhaled respiratory medicines.
  • AstraZeneca remains dedicated to transforming patient outcomes, while ensuring access and affordability of our innovative medicines.

FDA Approves New Antibiotic for Three Different Uses

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Wednesday, April 3, 2024
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"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.

Phathom Pharmaceuticals Announces VOQUEZNA® (vonoprazan) Tablets for Erosive GERD and Associated Heartburn Added to Express Scripts National Formularies for Commercial Patients

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Tuesday, February 13, 2024
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Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.

Key Points: 
  • Given that most Erosive GERD patients have already undergone treatment with a PPI, and many continue to express dissatisfaction with their current regimens, we are pleased with this outcome.
  • doi:10.1136/ bmjgast-2022-000941
    VOQUEZNA® (vonoprazan) is a potassium-competitive acid blocker (PCAB) indicated:
    for the healing of all grades of Erosive Esophagitis (Erosive Gastroesophageal Reflux Disease or Erosive GERD) and relief of heartburn associated with Erosive GERD in adults.
  • for the maintenance of healing of all grades of Erosive GERD and relief of heartburn associated with Erosive GERD in adults.
  • Renal Impairment: For the healing of Erosive GERD, dosage reduction is recommended in patients with severe renal impairment (eGFR

Napp announces authorisation of REZZAYO® (rezafungin) in Great Britain by the UK Medicines and Healthcare Products Regulatory Agency for the treatment of invasive candidiasis in adults1

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Friday, February 2, 2024
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Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2

Key Points: 
  • Napp Pharmaceuticals Limited, a member of the international network of Mundipharma independent associated companies, today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has authorised rezafungin for the treatment of invasive candidiasis in adults in Great Britain (GB).1,2
    This press release features multimedia.
  • Common adverse reactions include anaemia, hypomagnesaemia, hypophosphataemia, hypotension, wheezing, vomiting, nausea, abdominal pain, constipation, erythema, and rash.
  • Increased blood alkaline phosphatase, hepatic enzymes, alanine aminotransferase, aspartate aminotransferase and blood bilirubin were also common.
  • Transient infusion-related reactions have occurred with rezafungin, characterised by flushing, sensation of warmth, nausea, and chest tightness.2
    Rezafungin may cause increased risk of phototoxicity.

Sarepta Therapeutics Announces Positive Data from Part B of MOMENTUM, a Phase 2 Study of SRP-5051 in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 51

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Monday, January 29, 2024
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SRP-5051 is a next-generation peptide phosphorodiamidate morpholino oligomer (PPMO) treatment for patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.

Key Points: 
  • SRP-5051 is a next-generation peptide phosphorodiamidate morpholino oligomer (PPMO) treatment for patients with Duchenne muscular dystrophy who are amenable to exon 51 skipping.
  • Consistent dystrophin expression was seen in ambulatory (4.76%, n=11) and non-ambulatory (5.67%, n=9) participants at 28 weeks.
  • Hypomagnesemia has previously been identified in patients taking SRP-5051 and was managed and monitored through prophylactic magnesium supplementation as part of the study protocol.
  • Hypomagnesemia has been seen in earlier clinical studies of SRP-5051 and, throughout MOMENTUM Part B, supplemental magnesium was administered prophylactically.

AIRSUPRA® (albuterol/budesonide) now available as the first and only FDA-approved anti-inflammatory rescue option for asthma

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Monday, January 22, 2024
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In MANDALA, AIRSUPRA was superior to albuterol in reducing the risk of severe asthma exacerbations in patients with moderate to severe asthma.

Key Points: 
  • In MANDALA, AIRSUPRA was superior to albuterol in reducing the risk of severe asthma exacerbations in patients with moderate to severe asthma.
  • In DENALI, AIRSUPRA had a similar onset of bronchodilation compared to albuterol in patients with mild to moderate asthma.2
    The approach to treating asthma symptoms with rescue has changed.
  • The 2023 Global Initiative for Asthma (GINA) report supports a rescue approach that treats both symptoms and inflammation together.
  • Now, with AIRSUPRA available we can provide patients, especially those on maintenance therapy, another rescue option for managing their breakthrough symptoms.

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

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Tuesday, January 9, 2024
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Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

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Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Zytiga, abiraterone, Date of authorisation: 05/09/2011, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

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Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Carvykti, ciltacabtagene autoleucel, Date of authorisation: 25/05/2022, Revision: 5, Status: Authorised

Shattuck Labs Announces Positive Initial Topline Data from Ongoing Phase 1 A/B Dose Expansion Clinical Trial of SL-172154 with Azacitidine in Frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) and TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) Pat

Retrieved on: 
Wednesday, December 13, 2023
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AUSTIN, TX & DURHAM, NC, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today announced initial topline dose-expansion data from its ongoing Phase 1A/B clinical trial of SL-172154 in combination with AZA in frontline HR-MDS and TP53m AML patients. Initial data from the dose-expansion cohorts build on the complete dose-escalation data featured in a poster presentation on December 11, 2023 at the 65th ASH Annual Meeting.

Key Points: 
  • That patient remains disease free.” said Dr. Lini Pandite, MBChB, M.B.A., Chief Medical Officer of Shattuck.
  • TP53m AML: In 11 evaluable patients with previously untreated TP53m AML, two patients achieved a CR.
  • Safety: Preliminary data suggest that SL-172154 has an acceptable safety and tolerability profile in combination with azacitidine.
  • To listen to the live webcast, please visit the Investor Relations page of the Shattuck Labs website here .