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Dec 17, 2024 | 
jdsupra.com | Emma Murray
Jazz Pharmaceuticals’s ZIIHERA® On November 20th, Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
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Dec 16, 2024 | 
bigmoleculewatch.com | Emma Murray
Jazz Pharmaceuticals’s ZIIHERA® On November 20th, Jazz Pharmaceuticals announced that the FDA has approved ZIIHERA® (zanidatamab-hrii) on an accelerated basis for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.
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Nov 28, 2024 | 
biorxiv.org | Emma Murray |Leighton Lee |Cameron Mitchell |Gilian M. Hodge
AbstractThe organization of the cell′s cytoskeletal filaments is coordinated through a complex symphony of signaling cascades originating from internal and external cues. Two major actin regulatory pathways are signal transduction through Rho family GTPases and growth and proliferation signaling through the Hippo pathway. These two pathways act to define the actin cytoskeleton, controlling foundational cellular attributes such as morphology and polarity.
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Nov 12, 2024 | 
mondaq.com | Emma Murray
Daewoong Pharmaceutical announced on October 31 that it has signed a
joint sales agreement with Celltrion Pharm to market CT-P41 in
Korea. CT-P41, Celltrion's biosimilar of Amgen's PROLIA, is
scheduled to launch in Korea in the first half of 2025. Under the
agreement, Daewoong and Celltrion will jointly promote CT-P41 at
Korean general hospitals and clinics.
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Nov 8, 2024 | 
jdsupra.com | Emma Murray
Daewoong Pharmaceutical announced on October 31 that it has signed a joint sales agreement with Celltrion Pharm to market CT-P41 in Korea. CT-P41, Celltrion’s biosimilar of Amgen’s PROLIA, is scheduled to launch in Korea in the first half of 2025. Under the agreement, Daewoong and Celltrion will jointly promote CT-P41 at Korean general hospitals and clinics.
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Nov 7, 2024 | 
bigmoleculewatch.com | Emma Murray
Daewoong Pharmaceutical announced on October 31 that it has signed a joint sales agreement with Celltrion Pharm to market CT-P41 in Korea. CT-P41, Celltrion’s biosimilar of Amgen’s PROLIA, is scheduled to launch in Korea in the first half of 2025. Under the agreement, Daewoong and Celltrion will jointly promote CT-P41 at Korean general hospitals and clinics.
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Jul 26, 2024 | 
jdsupra.com | Emma Murray
Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. After Amgen’s BKMEV, Samsung’s EPYSQLI is the second FDA-approved eculizumab biosimilar.
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Jul 26, 2024 | 
mondaq.com | Emma Murray
Samsung Bioepis ("Samsung") announced on July 22 that the FDA approved its
BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion's
SOLIRIS. EPYSQLI has been approved for the treatment of patients
with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis
and atypical hemolytic uremic syndrome (aHUS) to inhibit
complement-mediated thrombotic microangiopathy. After Amgen's
BKMEV, Samsung's EPYSQLI is the second FDA-approved eculizumab
biosimilar.
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Jul 25, 2024 | 
bigmoleculewatch.com | Emma Murray
Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. After Amgen’s BKMEV, Samsung’s EPYSQLI is the second FDA-approved eculizumab biosimilar.
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May 17, 2024 | 
mondaq.com | Emma Murray
As we previously reported, Alexion Pharmaceuticals,
Inc. and Alexion Pharma International Operations Ltd. (collectively, "Alexion") sued Samsung Bioepis Co. Ltd. ("Samsung") in January 2024 in the U.S. District Court
for the District of Delaware. Alexion's complaint alleged
infringement of six patents under the BPCIA based on Samsung's
submission of its BLA for SB12, a proposed biosimilar to SOLIRIS
(eculizumab).
