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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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New Drug Designations - November 2023
INSIGHTS+

New Drug Designations – November 2023

Shots:  PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, EMA and China. This month’s report includes 3 biological drugs, 12 small molecules, 13 cell and gene therapies, 1 peptide, 3 exosome-based therapy and 4 devices  Atsena Therapeutics’ capsid AAV.SPR gene therapy, focused on the treatment of Leber congenital…
December 27, 2023

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Prescription Drugs Based Top 20 2022
TOP 20

Top 20 Prescription Drugs Based on 2022 Total Revenue

Shots: Prescription drugs have an instrumental role in effectively controlling chronic diseases like heart-related conditions, diabetes, arthritis, hypertension, and cancer, among others. Unlike over-the-counter drugs, prescription drugs are advised not to be taken without the authorization of a doctor In 2022, the global market size of prescription drugs was worth $1035.5B and is envisioned to…
November 21, 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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Disease of the Month: Cervical Cancer
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Disease of the Month: Cervical Cancer

“Get Informed, Get Screened, Get Vaccinated” – WHO Introduction: Cervical cancer is the 4th most common cancer among women and 7th most commonly occurring cancer overall. When a malignant growth or tumor occurs in the cells lining the walls of the cervix, it is called cervical cancer. The cervix is the narrow, lower part of the uterus…
January 12, 2023

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Prescription Drugs Top 20 2021
TOP 20

Top 20 Prescription Drugs Based on 2021 Total Revenue

Shots: The pharmaceutical companies have shown continual efforts towards developing enhanced and innovative treatment options to address the unmet needs of patients with disease eradication being the goal of developing these treatments Advancements in cellular and molecular biology have increased the possibilities for generating new pharmaceutical products imposing major impacts on the prevention, diagnosis, and…
November 10, 2022

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