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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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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_Moitreyee Chatterjee-Kishore_2023
VIEWPOINTS

Moitreyee Chatterjee-Kishore, in an absorbing conversation with PharmaShots, shares the highlights of the SPOTLIGHT & GLOW study

Shots:   Moitreyee Chatterjee-Kishore, HOD, Immuno-Oncology & Cancer Cell Therapy at Astellas shares insights from the P-III trials (SPOTLIGHT & GLOW)   In SPOTLIGHT and GLOW, zolbetuximab and chemotherapy demonstrated improved PFS and OS vs placebo plus chemotherapy, yielding positive outcomes for patients with advanced gastric or GEJ cancer.   Moitreyee highlights the ongoing clinical trials for the…
November 29, 2023

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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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