Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

Shots:Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar version of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s diseaseAs per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will…

ByRidhi RastogiAugust 5, 2025

NEWS

AstraZeneca Reports P-III (CARES) Trial Findings on Anselamimab for Light Chain Amyloidosis

Shots:AstraZeneca has reported P-III (CARES) trial findings assessing anselamimab (QW for 4wks. then Q2W till completion) + SoC vs PBO + SoC in pts (N=406) with stage IIIa (n=281) & stage IIIb (n=125) light chain (AL) amyloidosisTrial did not meet its 1EP of time to all-cause mortality & frequency of CV hospitalisations. However,…

ByRidhi RastogiJuly 16, 2025

NEWS

Galderma Initiates P-II Studies of Nemolizumab for Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO)

Shots:Galderma announced the initiation of two P‑II clinical studies evaluating the efficacy and safety of nemolizumab in pts with SSc and CPUOPatient enrollment for both studies is planned to start in H2’25, with expected completion in 2028 for SSc and in 2026 (US) for CPUONemolizumab is a mAb targeting the IL‑31 receptor…

ByDipanshu DixitJune 26, 2025

NEWS

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 Q2’25The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…

ByRidhi RastogiMay 7, 2025

VIEWPOINTS

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 colitisTremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammationAt…

BySaurabh ChaubeyFebruary 3, 2025

EXCLUSIVE

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

VIEWPOINTS

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

VIEWPOINTS

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

VIEWPOINTS

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

Polpharma Biologics Collaborates with Fresenius Kabi to Commercialize PB016 (Biosimilar, Entyvio)

AstraZeneca Reports P-III (CARES) Trial Findings on Anselamimab for Light Chain Amyloidosis

Galderma Initiates P-II Studies of Nemolizumab for Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO)

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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