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Daiichi Sankyo
News

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial01) Study Evaluating ENHERTU

Shots : Daiichi reported the first patient dosing in a P-III (DESTINY-Endometrial01) study evaluating ENHERTU (trastuzumab deruxtecan) + rilvegostomig or pembrolizumab vs Pt. chemotx. (carboplatin and paclitaxel) + pembrolizumab as 1L therapy, in HER2-expressing (IHC 3+/2+), pMMR advanced or recurrent endometrial cancer pts The study is assessing the efficacy and safety of ENHERTU (5.4 mg/kg)…
June 10, 2025

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Alvotech & Dr. Reddy’s
News

Alvotech Collaborates with Dr. Reddy’s to Co-Develop a Biosimilar Version of Keytruda

Shots: Alvotech has entered into a collaboration & license agreement with Dr. Reddy’s to co-develop, manufacture & commercialize a biosimilar version of Merck's Keytruda (pembrolizumab) globally As per the deal, Alvotech & Dr. Reddy’s will jointly develop & manufacture the biosimilar candidate, sharing costs & responsibilities, with each retaining the right to commercialize it globally,…
June 5, 2025

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Viewpoints_Ahsan Arozullah
VIEWPOINTS

Astellas at ASCO 2024: Ahsan Arozullah in an Illuminating Dialogue Exchange with PharmaShots

Shots:  At ASCO 2024, Astellas Pharma presented 16 abstracts across several types of cancers with unmet medical needs  Today at PharmaShots, we have Ahsan Arozullah Sr. VP, Head of Oncology Development, shedding light on the advancement Astellas’ oncology portfolio for urothelial carcinoma, gastric cancer, and prostate cancer  Ahsan talks about the presented results from studies…
September 16, 2024

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News

The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors

Shots:  The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer   HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity…
September 2, 2024

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Viewpoints_Jennifer Fernandez
VIEWPOINTS

TCOC Management in Oncology: Jennifer Fernandez from The Oncology Network in a Dialogue Exchange with PharmaShots

Shots:  Prominent oncology drugs like pembrolizumab and nivolumab were initially approved with weight-based dosing and gradually transitioned to fixed dozing. With the transformation in the dosing model, the average dose amount administered to patients increased dramatically in the Oncology Care Model  Today, at PharmaShots, we have Jennifer Fernandez from The Oncology Network, shedding light on…
August 7, 2024

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Bio-Thera New
News

Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda)

Shots:    Bio-Thera Solutions has commenced the patients dosing under the combined P-I/P-III study evaluating BAT3306, a biosimilar version of Keytruda (pembrolizumab)  The trial aims at assessing PK profile, safety & efficacy of BAT3306 vs Keytruda among patients (n=676) with non-squamous non-small cell lung cancer (nsNSCLC)  In addition, the company is also developing biosimilars of…
July 25, 2024

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Merck new
News

Merck’s Keytruda (pembrolizumab) in Combination with Chemotherapy Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer  

Shots:   The company received the positive opinion based on the results from the P-III (KEYNOTE-671) clinical trial evaluating neoadjuvant Keytruda + platinum-containing CT followed by adjuvant Keytruda monotx. vs neoadjuvant PBO in patients with resectable NSCLC at high risk of recurrence  The study met its dual 1EP by demonstrating a statistically significant & clinically meaningful…
February 26, 2024

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Samsung Bioepis
News

Samsung Bioepis Reports the Initiation of the P-I Trial Evaluation of SB27 (biosimilar, pembrolizumab) for the Treatment of Lung Cancer

Shots:  The company received the MHLW’s approval to initiate a P-I clinical trial for the bioequivalence evaluation of SB27 as compared to Keytruda (pembrolizumab)  The P-I clinical trial evaluates the safety, efficacy & immunogenicity of SB27 vs Keytruda in patients with Stage II-IIIA NSCLC following complete resection & adjuvant Platinum-based CT  Keytruda is a PD-1-blocking…
February 21, 2024

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Astellas
News

Astellas Receives the EMA’s Validation on Type II Variation Application for Padcev (enfortumab vedotin) in Combination with Keytruda (pembrolizumab) to Treat Advance Bladder Cancer

Shots The application was submitted based on the results from the P-III (EV-302/KEYNOTE-A39) clinical trial evaluating Padcev + Keytruda vs platinum-containing CT (SoC) in patients (n=886) with previously untreated la/mUC. The 1EPs of the study were OS & PFS whereas the 2EPs were ORR, DoR & safety The results depicted that the study met its…
January 29, 2024

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VIEWPOINTS

Unveiling FDA Acceptance: Ahsan Arozullah of Astellas Dives into Insights on PADCEV sBLAs for UC patients

Shots: Ahsan spoke about the US FDA acceptance for Priority Review of sBLAs for PADCEV and KEYTRUDA to treat patients with LA/mUC who are not eligible to receive cisplatin-containing CT He also talked about the study design and outcomes from the P-Ib/II (EV-103) clinical trial that supported the sBLA. The results from Dose Escalation/Cohort A…
August 17, 2023

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