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

NEWS

Geron’s Rytelo (Imetelstat) Gains the US FDA’s Approval to Treat Myelodysplastic Syndromes (MDS) with Transfusion-Dependent Anemia

Shots: The US FDA has approved Rytelo to treat low- to intermediate-risk MDS with transfusion-dependent (TD) anemia adults who did not respond to, lost response, or are not eligible for erythropoiesis-stimulating agents (ESA) The approval was supported by the P-III (IMerge) study of Rytelo vs PBO, depicting a 39.8% vs 15.0% RBC-TI rate for 8wks.…

ByDipanshu DixitJune 6, 2024

VIEWPOINTS

SEA Management: Donna Carstens from AstraZeneca in a Riveting Conversation with PharmaShots

Shots: Recently AstraZeneca’s FASENRA (benralizumab) received approval from the US FDA as an add-on maintenance treatment for patients (≥ 6 yrs.) with severe asthma and with an eosinophilic phenotype Today, at PharmaShots we have with us Donna Carstens, Senior Medical Director Respiratory, Fasenra at AstraZeneca Donna shares insights from the TATE study an open-label, multinational,…

BySaurabh ChaubeyJune 3, 2024

INSIGHTS+

New Drug Designations – April 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 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…

BySenior EditorMay 30, 2024

NEWS

Tris Pharma’s Onyda XR Gains the US FDA’s Approval for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Shots: The US FDA has granted approval to the company’s QD extended-release oral suspension of Onyda XR (clonidine hydrochloride) with nighttime dosing alone or as adj. to approved central nervous system (CNS) stimulant therapies for ADHD treatment in children (≥6yrs.). Its availability is anticipated in H2’24 The approval was supported by the data from studies…

ByDipanshu DixitMay 29, 2024

NEWS

Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer

Shots: The US FDA has granted accelerated approval to Amgen’s Imdelltra (DLL3-targeting bispecific T-cell engager) for treating extensive-stage small cell lung cancer (ES-SCLC) adults whose disease progressed post Pt-based CT. Full approval depends upon confirmatory trials The approval was based on the P-II (DeLLphi-301) study assessing Imdelltra (10mg, Q2W) in SCLC patients (n=99) failing on…

ByDipanshu DixitMay 16, 2024

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

Geron’s Rytelo (Imetelstat) Gains the US FDA’s Approval to Treat Myelodysplastic Syndromes (MDS) with Transfusion-Dependent Anemia

SEA Management: Donna Carstens from AstraZeneca in a Riveting Conversation with PharmaShots

New Drug Designations – April 2024

Tris Pharma’s Onyda XR Gains the US FDA’s Approval for the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer

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