Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Shots: The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25 The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…

ByRidhi Rastogi2 days ago

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Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Shots: Johnson & Johnson’s (J&J) Tremfya recently received its third approval from the US FDA, supported by the pivotal QUASAR study, which demonstrated significant remission after one year of treatment in adults with moderately to severely active ulcerative colitis Tremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammation At…

BySaurabh ChaubeyFebruary 3, 2025

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Decoding Approval: Moitreyee Chatterjee-Kishore from Astellas in an Exclusive Conversation with PharmaShots

Shots: Recently EC granted Marketing Authorization to Astellas’ VYLOY (zolbetuximab) in combination with chemotherapy for the treatment of patients with advanced gastric and GEJ cancers Zolbetuximab, a monoclonal antibody designed to target gastric tumor cells that express CLDN18.2 biomarker Today, at PharmaShots we have Dr. Moitreyee Chatterjee-Kishore the Head of Development, Immuno-Oncology and Cancer Cell…

BySaurabh ChaubeySeptember 26, 2024

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Unlocking Approval: Moitreyee Chatterjee-Kishore from Astellas & Kohei Shitara in Conversation with PharmaShots

Shots: East Asia and East Europe report significant incidences of Gastric Cancer. In 2022, Japan registered around 44,000 mortalities due to Gastric Cancer VYLOY, an anti-claudin 18.2 (CLDN18.2) monoclonal antibody, received Japan’s approval in combination with chemotherapy for patients with HER2 -ve, CLDN18.2+ve, unresectable, advanced, or recurrent gastric cancer Today, at PharmaShots we have Moitreyee…

BySaurabh ChaubeyJune 24, 2024

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Jennifer Davidson Highlights the Data from the Phase 3 QUASAR Induction Study 1

Shots: Jennifer Davidson, VP, of Medical Affairs Immunology, Johnson & Johnson Innovative Medicine shares insights from the data of the Phase III QUASAR induction study presented at the DDW'23 P-III QUASAR induction study 1 demonstrated positive results in patients who received TREMFYA 200 mg vs Placebo, with most of the patients achieving remission at week…

BySaurabh ChaubeyNovember 13, 2023

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Marija Geertsen shares highlights of the data presented at the 65th AHS Annual Meeting

Shots: Marija Geertsen shares the highlights of the data presented at the 65th AHS annual meeting, including insights from real-world experience with VYEPTI's review study With a focus on the review study that delved into the experiences of 94 patients receiving VYEPTI treatment, Marija provides an in-depth account of the PROMISE 1 and PROMISE 2…

BySaurabh ChaubeyNovember 6, 2023

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Decoding Approval: Moitreyee Chatterjee-Kishore from Astellas in an Exclusive Conversation with PharmaShots

Unlocking Approval: Moitreyee Chatterjee-Kishore from Astellas & Kohei Shitara in Conversation with PharmaShots

Jennifer Davidson Highlights the Data from the Phase 3 QUASAR Induction Study 1

Marija Geertsen shares highlights of the data presented at the 65th AHS Annual Meeting

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Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Decoding Approval: Moitreyee Chatterjee-Kishore from Astellas in an Exclusive Conversation with PharmaShots

Unlocking Approval: Moitreyee Chatterjee-Kishore from Astellas & Kohei Shitara in Conversation with PharmaShots

Jennifer Davidson Highlights the Data from the Phase 3 QUASAR Induction Study 1

Marija Geertsen shares highlights of the data presented at the 65th AHS Annual Meeting

FOLLW US

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