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Daiichi Sankyo & Astrazeneca
News

Daiichi Sankyo and AstraZeneca Report the US FDA’s Approval of Enhertu for HER2 Low/Ultralow Metastatic Breast Cancer (MBC), Progressed on Endocrine Therapies

Shots:The US FDA’s approval of Enhertu for HR+, HER2 low/ultralow MBC, progressed on endocrine therapies, was based on P-III (DESTINY-Breast06) study compared to CT shared at ASCO 2024 & published in The NEJM. AZ will pay $175M for this milestone Study depicted PFS of 36%, mPFS of 13.2 vs 8.1mos., cORR of 62.6%…
January 28, 20250Comments

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Teva and Alvotech
News

Alvotech & Teva Reports the US FDA’s BLA Acceptance of AVT05 (Biosimilar, Simponi & Simponi Aria)

Shots:The US FDA has accepted BLA for AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab), with completion of the review process anticipated in Q4’25 Alvotech reported topline results from a confirmatory trial evaluating the efficacy, safety, & immunogenicity of AVT05 vs Simponi in mod. to sev. rheumatoid arthritis patients in Apr…
January 28, 20250Comments

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News

Neurocrine Biosciences and Takeda Amend Partnership to Develop and Commercialize Osavampator in Japan

Shots:Neurocrine & Takeda have revised their 2020 collaboration to develop & commercialize osavampator (NBI-1065845/TAK-653), which originally granted Neurocrine exclusive license to osavampator, NBI-1070770, & the GPR139 antagonist program As per the amendment, Neurocrine will get exclusive rights to develop & market osavampator to treat major depressive disorder (MDD) globally, while Takeda will reacquire…
January 28, 20250Comments

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Key Takeaways of J.P. Morgan Healthcare Conference 2025
INSIGHTS+

Key Takeaways of J.P. Morgan Healthcare Conference 2025

Shots: The 43rd Annual J.P. Morgan Conference took place from 13th to 16th January in San Francisco, USA. J.P. Morgan Healthcare Conference serves as a pioneering hub that features presentations and dialogues on the advances of the healthcare industry by bringing healthcare professionals, researchers, manufacturers, and other healthcare stakeholders to one platform.  Innovation remained the…
January 28, 20250Comments

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Viewpoints_Mina Makar
VIEWPOINTS

Cardiology Care and Beyond: Mina Makar from AstraZeneca in a Riveting Dialogue Exchange with PharmaShots

Shots:At ESC 2024, AstraZeneca presented insights from the real-world OverTTuRe study, exploring the challenges of early diagnosis in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) Mina Makar, SVP and Commercial Lead of the Global Cardiovascular, Renal, and Metabolism (CVRM) Biopharmaceuticals Business Unit at AstraZeneca, shared real-world insights on how ATTR-CM manifests as cardiac symptoms Mina highlighted the…
January 27, 20250Comments

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News

Merck and Eisai Reveal Latest Data from P-III (LEAP-015) Trial of Keytruda (pembrolizumab) and Lenvima (lenvatinib) Regimen to Treat Gastroesophageal Adenocarcinoma

Shots:P-III (LEAP-015) trial assessed Keytruda + Lenvima + CT (CAPOX or mFOLFOX6 regimen) as a 1L therapy for LA/M inoperable HER2- GE adenocarcinoma pts in 2 parts (P1: safety run-in & P2: main trial). LEAP program is also assessing it in hepatocellular carcinoma & esophageal cancer P2 pts (n=880) received Keytruda (400mg, IV…
January 27, 20250Comments

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News

Cstone Join Forces with SteinCares to Commercialize Sugemalimab in 10 Latin American Countries

Shots:CStone & SteinCares have partnered to commercialize sugemalimab, where SteinCares will gain its commercialization rights in 10 LATAM countries (incl. Brazil, Argentina, Mexico, Chile, Colombia, Costa Rica, Panama, Peru, Guatemala, & Ecuador), & CStone will handle its supply As per the terms, SteinCares will handle regulatory filings & marketing of sugemalimab in exchange for upfront, regulatory & commercial milestones as well as…
January 27, 20250Comments

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