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The EMA approved 2 BLA and 6 New Chemical Entities in January 2024, leading to treatments for patients and advances in the healthcare industry
In January 2024, the major highlighted drugs were Padcev to treat Bladder Cancer and Eylea for the treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME)
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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…
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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…
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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…
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The second quarter of 2023 highlights multiple clinical trial results, approvals, and numerous deals. There are major alliances in this quarter which include Merck acquired Prometheus for ~$10.8B and Astellas entered into a definitive agreement to acquire Iveric Bio for ~$5.9B
The second quarter of the year also showcases multiple approvals of the therapies…
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The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 54 novel products in 2023
In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's Disease
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Immunology focuses on analyzing all aspects of the immune system in both healthy and diseased states, from its structure & function to its disorders, blood banking, immunization & organ transplant
Along with the enhanced utilization of immunotherapies for immunological & autoimmune diseases, monoclonal antibodies have also showcased a great potential to be used as…
The second quarter of 2022 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, AstraZeneca’s Farxiga (dapagliflozin) meet its primary endpoints for heart failure with a preserved ejection fraction
Starting with the latest acquisitions, Pfizer acquire Biohaven for ~$11.6B, GSK acquire Affinivax for ~$3.3B. The second quarter of the year…
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The biopharma industry saw numerous deal terminations in 2021. Clinical and regulatory results, change of control limitations, and strategic reprioritizations were among the most common reasons for deal termination.
SOBI and Advent's acquisition agreement in 2021 ranked first under which Advent International offered to acquire SOBI. The second position goes to Galapagos’ development and…
Oncology is a rapidly evolving therapy area and all of the top Biopharma players are investing in the research and development of cancer therapies. In 2020- the world witnessed a major acquisition of Immunomedic by Gilead of $21B for Trodelvy
Our team at PharmaShots has compiled a list of top 20 oncology companies based on…

