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Pfizer & Astellas
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…
February 12, 2025

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Astellas
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:…
January 10, 2025

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Astellas
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 …
January 6, 2025

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Exclusive_Moitreyee Chatterjee-Kishore_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…
September 26, 2024

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Exclusive_Ahsan Arozullah_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…
September 4, 2024

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Insights + EMA Marketing Authorization of New Drugs in July 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…
August 14, 2024

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Astellas
NEWS

Astellas Reports the CHMP’s Positive Opinion of Zolbetuximab to Treat Gastric and Gastroesophageal Junction Cancer 

  Shots:    The CHMP has granted positive opinion to zolbetuximab + CT, with the decision anticipated in Oct 2024 & applicable across the whole EU plus Iceland, Liechtenstein & Norway. Other worldwide regulatory applications are under review  Opinion was supported by 2 P-III studies assessing zolbetuximab plus mFOLFOX6 [SPOTLIGHT (n=565)] & CAPOX [GLOW (n=507)] vs PBO…
July 29, 2024

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Immunology Top 20 2024
TOP 20

Top 20 Immunology Companies of 2024

Shots: Immunology remains one of the most explored therapy areas. Companies focusing on immunology are steadfastly working to advance treatment options by developing drugs, vaccines, and antibodies In 2023, the global immunology market size was valued at $98.22B and expected to register $263.22B by 2033, with a CAGR of 10.36% from 2024 to 2033. AbbVie…
July 25, 2024

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VIEWPOINTS_Ahsan Arozullah_2024
VIEWPOINTS

A New Hope in Bladder Cancer Combination Therapy: PharmaShots in Conversation with Ahsan Arozullah

Shots:  Transformative combination therapies add wonder to oncology therapeutics now and then. Dr. Ahsan Arozullah, in another engaging conversation with PharmaShots, talks about Padcev + Keytruda therapy for adult patients suffering from locally advanced or metastatic urothelial cancer (la/mUC)  Ahsan shares insights from the P-III (EV-302) trial based on which the FDA accepted Padcev +…
April 2, 2024

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