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

NEWS

Azurity Pharmaceuticals’ Myhibbin (Mycophenolate Mofetil) Receives the US FDA’s Approval to Treat Organ Rejection

Shots: The US FDA has approved Azurity Pharmaceuticals’ Myhibbin oral suspension with its commercial availability anticipated in Q2’24 Myhibbin in addition to other immunosuppressants is intended for preventing organ rejection in adults & pediatric patients (age: ≥3mos.) of allogeneic kidney, heart, or liver transplant Mycophenolate mofetil, an antimetabolite immunosuppressant, works on the immune system of…

ByDipanshu DixitMay 6, 2024

NEWS

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira)

Shots: Boehringer Ingelheim has received the US FDA’s approval for the high-concentration (100mg/mL), citrate-free formulation of Cyltezo (biosimilar to Humira) to treat various chronic inflammatory diseases. Its low concentration of 50mg/mL has been available since Jul 2023 The approval was supported partly by the data from P-I (VOLTAIRE-HCLF) evaluating the bioavailability of high-concentration vs low-concentration…

ByDipanshu DixitMay 1, 2024

INSIGHTS+

New Drug Designations – March 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices Trellis Bioscience's…

BySenior EditorApril 30, 2024

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

Azurity Pharmaceuticals’ Myhibbin (Mycophenolate Mofetil) Receives the US FDA’s Approval to Treat Organ Rejection

The US FDA Approves High Concentration of Boehringer Ingelheim’s Cyltezo (Biosimilar, Humira)

New Drug Designations – March 2024

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