Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

Shots: The US FDA and EMA have accepted the BLA & MAA of BAT2206 for treating moderate to severe plaque PsO in adults eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active ulcerative colitis. BLA in China is under review The applications were supported by…

ByDipanshu DixitJuly 24, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in June 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2024 The US FDA approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Ipsen’s Iqirvo for the treatment…

ByDipanshu DixitJuly 16, 2024

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) &…

ByDipanshu DixitJuly 2, 2024

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…

ByDipanshu DixitJune 28, 2024

NEWS

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Shots: The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability…

ByDipanshu DixitJune 28, 2024

NEWS

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Shots: The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability…

ByDipanshu DixitJune 28, 2024

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…

ByDipanshu DixitJune 28, 2024

NEWS

Verona Pharma’s Ohtuvayre (Ensifentrine) Receives the US FDA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: The US FDA has approved Ohtuvayre as a maintenance therapy to treat COPD patients, with its launch anticipated in Q3’24 The approval was based on the P-III (ENHANCE-1 & ENHANCE-2) studies analyzing Ohtuvayre monotx. or in addition with other maintenance therapies. Trials reached their 1EPs showing improved lung function; results were published in the…

ByDipanshu DixitJune 26, 2024

NEWS

Botanix Pharmaceuticals’ Sofdra (Sofpironium) Receives the US FDA’s Approval to Treat Primary Axillary Hyperhidrosis

Shots: The US FDA has granted approval to Sofdra gel (12.45%) for the treatment of adults & children (≥9yrs.) with primary axillary hyperhidrosis The approval was based on the two pivotal P-III (CARDIGAN) trials assessing the efficacy & safety of Sofdra vs vehicle in primary axillary hyperhidrosis patients (n=701). Trials reached its 1EPs & 2EPs…

ByDipanshu DixitJune 20, 2024

NEWS

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis

Shots: The US FDA has granted accelerated approval to Iqirvo (80mg tablets) in addition to ursodeoxycholic acid (UDCA) to treat PBC adults having inadequate response to UDCA or as monotx. in UDCA intolerant patients. Full approval depends on (ELFIDENCE) confirmatory trial The approval was based on a P-III (ELATIVE) study assessing the safety & efficacy…

ByDipanshu DixitJune 10, 2024

Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU

Insights+: The US FDA New Drug Approvals in June 2024

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

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara)

Verona Pharma’s Ohtuvayre (Ensifentrine) Receives the US FDA’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Botanix Pharmaceuticals’ Sofdra (Sofpironium) Receives the US FDA’s Approval to Treat Primary Axillary Hyperhidrosis

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis

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