Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011

Shots: Evopoint Biosciences has granted Astellas exclusive license to develop & commercialize XNW27011 globally, excl. Mainland China, Hong Kong, Macao & Taiwan As per the deal, Evopoint will receive $130M upfront as well as ~$70M as near-term payments in addition to ~$1.34B in development, regulatory & commercial milestones, with net sales-based royalties XNW27011, an CLDN18.2-specific…

ByRidhi RastogiMay 30, 2025

News

Astellas Collaborates with Chromatin Bioscience to Develop Cell-Selective Synthetic Promoters

Shots: Astellas has entered into a collaboration agreement with Chromatin Bioscience to design cell-selective synthetic promoters As per the agreement, Chromatin will utilize its chromatinLENS platform to develop cell-selective synthetic promoters for Astellas’ target profile, allowing precise & durable gene expression in specific cells chromatinLENS platform identifies gene regulatory elements from the dark genome &…

ByRidhi RastogiApril 14, 2025

News

Astellas to Establish Joint Venture with YASKAWA for Cell Therapy Manufacturing

Shots: Astellas has entered into definitive agreement with YASKAWA to establish a joint venture for the development of a cell therapy product manufacturing platform based on previously signed MoU (May 21, 2024) In joint venture, Astellas will own 60% & YASKAWA 40% with $30.14M (¥4.5B) capital & expected to establish in Sept 2025, subject…

ByRidhi RastogiMarch 6, 2025

News

Pfizer and Astellas Report Follow-up Data from P-III (KEYNOTE-A39/EV-302) Trial of Padcev + Keytruda for Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

Shots: Pfizer & Astellas have reported follow-up data from P-III (KEYNOTE-A39/EV-302) trial assessing Padcev + Keytruda vs Pt-based CT in previously untreated la/mUCpts (n=886) The 12mos. follow up study (mFU: 29.1mos.) showed reduced risk of death by 49% & decrease in PFS by 52% (mPFS: 12.5 vs 6.3mos.) with improved mOS (33.8 vs 15.9mos.), where OS…

ByRidhi RastogiFebruary 12, 2025

News

Astellas Reports the Health Canada’s Approval of Vyloy (Zolbetuximab) Plus Chemotherapy for Advanced G/GEJ Cancer

Shots: The Health Canada has approved Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic CLDN 18.2+/HER2-ve G/GEJ adenocarcinoma, with further submissions under review. In addition, Canada’s Drug Agency (CDA-AMC) recommended reimbursement of Vyloy with conditions Approval was based on the P-III (SPOTLIGHT: n= 565 & GLOW:…

ByRidhi RastogiJanuary 10, 2025

News

Astellas’ Vyloy (Zolbetuximab) Secures the NMPA’s Approval as a 1L Treatment of Advanced G/GEJ Adenocarcinoma

Shots: The NMPA has granted approval to Vyloy + fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic HER2-, CLDN18.2+ G/GEJ adenocarcinoma Approval was supported by P-III (GLOW: n=145 & SPOTLIGHT: n=36) studies assessing Vyloy + CAPOX & mFOLFOX6, respectively, vs PBO among Chinese patients with this indication …

ByRidhi RastogiJanuary 6, 2025

News

Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer

Shots: The US FDA has granted approval to Vyloy plus fluoropyrimidine & Pt-based CT as a 1L treatment of locally advanced unresectable or metastatic CLDN 18.2+, HER2-ve G/GEJ adenocarcinoma Approval was based on the P-III (SPOTLIGHT & GLOW) studies assessing Vyloy + mFOLFOX6 and Vyloy + CAPOX, respectively, vs PBO as a 1L treatment of…

ByDipanshu DixitOctober 18, 2024

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

EXCLUSIVE

Advancing Urothelial Carcinoma Care: Ahsan Arozullah from Astellas Pharma in an Exclusive Interview with PharmaShots

Shots: Recently, the CHMP of the EMA adopted a positive opinion for Astellas’ Padcev + Keytruda combination therapy as the first-line treatment of patients with unresectable or metastatic urothelial cancer Today, in an exclusive coverage, we bring an enlightening conversation with Ahsan Arozullah from Astellas Pharma, sharing insights from the P-III EV-302 study Astellas looks…

BySaurabh ChaubeySeptember 4, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in July 2024

Shots: The EMA granted Positive Opinion to 2 Biologics and 5 New Chemical Entities in July 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Johnson & Johnson’s Yuvanci to treat Pulmonary Arterial Hypertension (PAH) and Astellas’ Vyloy + CT for Gastric & Gastroesophageal Junction Cancer PharmaShots has compiled a list…

ByDipanshu DixitAugust 14, 2024

Astellas Enters a ~$1.54B Licensing Agreement with Evopoint Biosciences to Develop & Commercialize XNW27011

Astellas Collaborates with Chromatin Bioscience to Develop Cell-Selective Synthetic Promoters

Astellas to Establish Joint Venture with YASKAWA for Cell Therapy Manufacturing

Pfizer and Astellas Report Follow-up Data from P-III (KEYNOTE-A39/EV-302) Trial of Padcev + Keytruda for Locally Advanced or Metastatic Urothelial Cancer (la/mUC)

Astellas Reports the Health Canada’s Approval of Vyloy (Zolbetuximab) Plus Chemotherapy for Advanced G/GEJ Cancer

Astellas’ Vyloy (Zolbetuximab) Secures the NMPA’s Approval as a 1L Treatment of Advanced G/GEJ Adenocarcinoma

Astellas Reports the US FDA’s Approval of Vyloy (Zolbetuximab-clzb) to Treat Advanced G/GEJ Cancer

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

Advancing Urothelial Carcinoma Care: Ahsan Arozullah from Astellas Pharma in an Exclusive Interview with PharmaShots

Insights+: EMA Marketing Authorization of New Drugs in July 2024

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