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Servier
NEWS

Servier Reports the US FDA’s Approval of Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma 

Shots:     The US FDA has granted approval to Voranigo (QD) tablets for treating patients (age: ≥12yrs.) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery  Approval was based on P-III (INDIGO) trial assessing the safety & efficacy of Voranigo vs PBO to treat residual or recurrent grade 2 glioma with IDH1/2 mutation after…
August 6, 2024

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Insights+ Key Biosimilars Events of July 2024
INSIGHTS+

Insights+ Key Biosimilars Events of July 2024

Shots:     Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency      Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients      The major highlights were the US FDA’s approval of Samsung Bioepis’ Epysqli for Treating Paroxysmal…
August 1, 2024

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New Drug Designations - June 2024
INSIGHTS+

New Drug Designations – June 2024

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 7 small molecules, 5 biologics, 8 cell & gene therapies, 2 recombinant fusion protein, and 3 devices   This month, ChromaDex’s Nicotinamide Riboside Chloride received US FDA’s ODD &…
July 30, 2024

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Sun Pharma
NEWS

Sun Pharma’s Leqselvi (Deuruxolitinib) Receives the US FDA’s Approval for Treating Severe Alopecia Areata 

Shots:    The US FDA has granted approval to the company’s Leqselvi (8mg) tablets for treating severe alopecia areata adults  Approval was supported by two P-III (THRIVE-AA1 & THRIVE-AA2) studies that assessed the scalp hair regrowth using the SALT score with Leqselvi (8mg or 12mg, BID) vs PBO in adults (n=1223; 18-65yrs.) with severe alopecia areata…
July 25, 2024

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Eli Lilly
NEWS

Eli Lilly Reports the US FDA’s Approval of Kisunla (donanemab-azbt) to Treat Early Symptomatic Alzheimer’s Disease 

Shots:   The approval of Kisunla (350mg/20mL, IV, QM) for early symptomatic Alzheimer's disease was based on P-III (TRAILBLAZER-ALZ 2) study. Coverage & reimbursement is available through National Coverage Determination with Coverage with Evidence Development  The P-III (TRAILBLAZER-ALZ 2) trial assessed Kisunla vs PBO in patients (n=1,736) with early symptomatic AD (MCI or mild dementia) &…
July 2, 2024

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NEWS

Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea) 

Shots:  The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO)  The approval was based on analytical, pre-clinical, clinical and manufacturing data…
June 28, 2024

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