GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…

ByRidhi RastogiMay 19, 2025

NEWS

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHRA has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy incl. Revlimid; review ongoing in 14 markets incl. US (PDUFA: Jul 23, 2025), EU, Canada, Japan [priority review (PR)], China (PR for DREAMM-7), & Switzerland (PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep…

ByRidhi RastogiApril 21, 2025

NEWS

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Darzalex (SC) + bortezomib, lenalidomide & dexamethasone (D-VRd) to treat NDMM pts; sBLA under the US FDA’s review Approval was based on P-III (CEPHEUS) trial assessing D-VRd (n=197) vs VRd (n=198) in 395 ASCT-ineligible or deferred pts, in 13 countries across the EU, North & South America At 59mos. mFU, trial…

ByRidhi RastogiApril 8, 2025

TOP 20

Top 20 Cell and Gene Therapy Companies of 2024

Shots: Cell and gene therapies provide a promising opportunity to enhance care for unmet healthcare needs. Biopharma companies are actively exploring these therapies across multiple indications to address healthcare gaps in rare and chronic diseases In 2023, the cell and gene therapy market was valued at $18.2B and is projected to grow to $117.46B by…

ByPrince GiriNovember 28, 2024

VIEWPOINTS

Fund Raising Initiative: Yelak Biru from International Myeloma Foundation in Conversation with PharmaShots

Shots: As a fund-raising initiative, the International Myeloma Foundation began a 3-day, 2-night cycling expedition from Aug 29thto Sep 3rd The initiative supports patient education, advocacy, and next-gen research to advance a cure for multiple myeloma Today, at PharmaShots we have Yelak Biru, President and CEO of the International Myeloma Foundation, shedding light on this…

BySaurabh ChaubeyOctober 16, 2024

EXCLUSIVE

Advancing Care for Hematologic Malignancies: Chris Heery from Arcellx in a Stimulating Dialogue Exchange with PharmaShots

Shots: Arcellx’s Anito-cel, a BCMA CAR-T therapy recently got the FTD, ODD, RMAT designations by the FDA for the treatment of patients with relapsed or refractory multiple myeloma (r/rMM) Today, at PharmaShots we have Chris Heery, Chief Medical Officer at Arcellx, shedding light on Anito-Cel therapy in advancing care for multiple myeloma In late 2022,…

BySaurabh ChaubeySeptember 30, 2024

VIEWPOINTS

Establishing Safe Treatment: Dr. Robert Rifikin from Rocky Mountain Cancer Centers in Conversation with PharmaShots

Shots: There is an average lifetime risk of getting multiple myeloma of about 1 in 103 men and 1 in 131 women in the United States Treatment of multiple myeloma using fourth-line therapy like teclistamab can induce issues like cytokine release syndrome (CRS) and neurotoxicity Today, at PharmaShots we have Dr. Robert Rifikin from Rocky…

BySaurabh ChaubeyAugust 5, 2024

NEWS

BMS Receives the CHMP’s Positive Opinion for Abecma (idecabtagene vicleucel) to Treat Multiple Myeloma

Shots: The CHMP positive opinion was based on the results from the P-III (KarMMa-3) clinical trial evaluating Abecma vs standard regimens in patients with r/r multiple myeloma following 2-4 prior lines of therapy. The 1EP of the study was PFS & 2EPs were ORR & OS Following a median follow-up of 30.9mos., the study showed…

ByDipanshu DixitJanuary 26, 2024

INSIGHTS+

New Drug Designations – August 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

BySenior EditorSeptember 18, 2023

INSIGHTS+

Top Performing Drug of 2021 – Darzalex (March Edition)

Shots: The ongoing series of the top-performing drugs of 2021 based on revenue is continued by Darzalex as the top-performing drug for March month Darzalex is a CD38-directed cytolytic antibody indicated for the treatment of adult patients with multiple myeloma in combination with different drugs The report summarizes the key features of Darzalex including revenue…

BySenior EditorMarch 21, 2023

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

GSK Receives the MHRA’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Johnson & Johnson Receives the EC’s Approval for Darzalex Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Top 20 Cell and Gene Therapy Companies of 2024

Fund Raising Initiative: Yelak Biru from International Myeloma Foundation in Conversation with PharmaShots

Advancing Care for Hematologic Malignancies: Chris Heery from Arcellx in a Stimulating Dialogue Exchange with PharmaShots

Establishing Safe Treatment: Dr. Robert Rifikin from Rocky Mountain Cancer Centers in Conversation with PharmaShots

BMS Receives the CHMP’s Positive Opinion for Abecma (idecabtagene vicleucel) to Treat Multiple Myeloma

New Drug Designations – August 2023

Top Performing Drug of 2021 – Darzalex (March Edition)

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