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Home » Topics » Disease categories and therapies » Hematologic

Hematologic
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EU flag, syringe, capsules

CHMP nods for Korjuny, Alhemo; no, again, for Translarna, masitinib

Oct. 21, 2024
By Nuala Moran
The first bispecific antibody to win regulatory approval is about to make a comeback 10 years after being taken off the market in Europe for commercial reasons. Catumaxomab, then called Removab, and now reborn with the brand name Korjuny, received a positive opinion for the treatment of malignant ascites from the EMA’s Committee for Medicinal Products for Human Use (CHMP,) at its monthly meeting Oct. 14 to 17.
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Hematologic

Shaanxi Micot Technology discovers new anticoagulant reversal agents

Oct. 18, 2024
Shaanxi Micot Technology Co. Ltd. has described theophylline derivatives acting as anticoagulant reversal agents reported to be useful for the treatment of hemorrhagic disorders.
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Pfizer notches another hemophilia approval

Oct. 14, 2024
By Lee Landenberger
The U.S. FDA has approved the second hemophilia drug in nearly six months from Pfizer Inc. This one, Hympavzi (marstacimab), is for preventing or reducing bleeding in those age 12 and older with hemophilia A and B. Hympavzi heralds a couple of market boundary breakers: it’s the first and only anti-tissue factor pathway inhibitor approved in the U.S. for hemophilia A or B and the first hemophilia medicine approved in the U.S. to be administered using a pre-filled, auto-injector pen.
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3D dollar sign

Recordati buys rare disease drug Enjaymo in $825M Sanofi deal

Oct. 4, 2024
By Jennifer Boggs
Recordati SpA is shelling out $825 million up front for global rights to Enjaymo (sutimlimab), the only therapy approved for treating the rare disease cold agglutinin disease. In the deal with Sanofi SA, which won U.S. FDA approval of the antibody drug in 2022, the Italian pharma agreed to pay up to $250 million more should net sales reach certain thresholds.
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Pfizer pulls sickle cell drug after deaths and health complications

Sep. 26, 2024
By Lee Landenberger
The risk and benefit of Pfizer Inc.’s oral sickle cell disease drug Oxbryta (voxelotor) has flipped, prompted by what the company called new clinical data indicating “an imbalance in vaso-occlusive crises and fatal events” that need more study. Based on an EMA recommendation, Pfizer said it is voluntarily recalling all lots of Oxbryta from wherever it’s approved worldwide. Pfizer also is shuttering its Oxbryta clinical studies and expanded access programs.
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EMA icons

EMA’s CHMP recommends Hympavzi for hemophilia, Elahere for cancer

Sep. 23, 2024
By Nuala Moran
For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
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Blood sample, DNA
Hematologic

Metagenomi reports preclinical data supporting development of MGX-001 for hemophilia A

Sep. 4, 2024
Metagenomi Inc. has reported data from an ongoing preclinical study designed to provide evidence supporting the potential durability and safety of the company’s hemophilia A gene editing investigational therapy, MGX-001.
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Illustration of zebrafish, gene editing.
Hematologic

Zebrafish lacking Dnajc21 show cytopenia and impaired nucleotide metabolism

Aug. 30, 2024
Shwachman-Diamond syndrome is an inherited bone marrow failure syndrome characterized by exocrine pancreatic insufficiency, cytopenia, growth restriction and skeletal abnormalities, and for which primary treatment is allogeneic hematopoietic stem cell transplantation, which is associated with significant toxicity.
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Sickle cells
Hematologic

Targeting PGC-1α as therapeutic strategy against sickle cell disease

Aug. 26, 2024
Recent studies have shown that up-regulation of peroxisome proliferator-activated receptor γ coactivator-1α (PGC-1α) was able to induce fetal hemoglobin synthesis in human primary erythroblasts.
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Hematologic

New PHD2 inhibitors disclosed in Oxford University Innovations patent

Aug. 22, 2024
Oxford University Innovations Ltd. has divulged Egl nine homolog 1 (EGLN1; HPH-2; PHD2) inhibitors reported to be useful for the treatment of anemia, ischemia, cardiovascular disorders, inflammatory disorders, irritable bowel syndrome, chronic kidney disease, Parkinson’s disease and Alzheimer’s disease, among others.
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