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Gilead (2)
US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC) 
Shots:     Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis  The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical…
August 14, 2024
Sandoz
Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) to Treat Neovascular Age-Related Macular Degeneration 
Shots:  The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients  Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD…
August 12, 2024
Ascendis Pharma
Ascendis Pharma’s Yorvipath Receives the US FDA’s Approval to Treat Hypoparathyroidism 
Shots:      The US FDA has approved Yorvipath (QD) tablets for treating hypoparathyroidism patients, with its initial supply planned during Q1’25  The approval was supported by the P-II (PaTH Forward) as well as P-III (PaTHway) clinical trials conducted worldwide   Ascendis will further introduce the US Ascendis Signature Access Program (A.S.A.P.) for treatment support & financial assistance…
August 9, 2024
Takeda
Takeda Reports the EC’s Approval of Adzynma to Treat Congenital Thrombotic Thrombocytopenic Purpura (cTTP) 
Shots:    The EC has approved Adzynma (recombinant ADAMTS13) to treat ADAMTS13 deficiency in cTTP adults & children. Adzynma is also being assessed under P-IIb study for immune-mediated thrombotic thrombocytopenic purpura (iTTP)  Approval was based on the P-III study assessing Adzynma to treat cTTP, published in the NEJM, with patients receiving Adzynma (40IU/kg, IV, weekly) or…
August 7, 2024
Lupin Reports the P-III Study Completion of LUBT010 (Biosimilar, Lucentis) for Neovascular Age-related Macular Degeneration 
Shots:  Lupin has concluded P-III study evaluating the efficacy, safety & immunogenicity of LUBT010 (0.5mg, intravitreal, QM for 1yr.) vs Lucentis in wet AMD adults (n=600) across India, US, EU & Russia  The trial met its 1EP, showing therapeutic equivalence in visual acuity improvement plus similarity in safety & immunogenicity b/w both the drugs. Results will…
August 5, 2024
xbrane
Xbrane Biopharma Reclaims Rights of BIIB801 (Biosimilar, Cimzia) from Biogen 
Shots:  Xbrane Biopharma will reclaim full rights of BIIB801 from Biogen after the termination of their commercialization and license agreement. BIIB801 is a biosimilar version of Cimzia (certolizumab pegol), under non-clinical development  The agreement was signed b/w Xbrane & Biogen in Feb 2022, under which Xbrane received a non-refundable $8M upfront. It has been terminated…
August 1, 2024
Celltrion
Celltrion’s Steqeyma (Biosimilar, Stelara) Receives the Health Canada’s Approval to Treat Various Chronic Inflammatory Conditions 
Shots:  Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis  Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate…
August 1, 2024
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