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Rigel Signs ~$445M Licensing Pact with Arvinas and Pfizer for Veppanu

Shots: Rigel has entered into an exclusive, global license agreement with Arvinas & Pfizer to develop, manufacture & commercialize FDA-approved Veppanu (vepdegestrant) for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer. As per the deal, Rigel will pay Arvinas & Pfizer $70M upfront, $15M in upon completion of transition activities, & ~$320M in milestones plus tiered royalties…

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Guardant Health Secures the US FDA Approval for Guardant360 CDx as a Companion Diagnostic for Arvinas’ Veppanu

Shots: The US FDA has approved Guardant360 CDx as a companion diagnostic to identify pts with ESR1mutations in ER+, HER2- advanced or metastatic breast cancer who may benefit from treatment with Arvinas’ Veppanu (vepdegestrant) Approval was supported by clinical data showing that Guardant360 CDx, a non-invasive liquid biopsy test, demonstrated clinical utility in identifying ESR1 mutations to…

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Arvinas and Pfizer Report the US FDA Approval of Veppanu (Vepdegestrant) for ESR1-Mutated Breast Cancer

Shots: FDA approved Veppanu to treat adults with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer who received ≥1L of endocrine therapy, prior to PDUFA date of Jun 5, 2026; Arvinas & Pfizer plan to select a third-party partner for commercialization NDA was backed by P-III (VERITAC-2) trial assessing Veppanu alone vs fulvestrant in mentioned pts…

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Arvinas Reports the US FDA’s NDA Acceptance of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: The US FDA has accepted NDA of vepdegestrant to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy (PDUFA: Jun 5, 2026) NDA was backed by P-III (VERITAC-2) trial assessing vepdegestrant alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed…

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Arvinas and Pfizer

Arvinas and Pfizer Report the US FDA’s NDA Submission of Vepdegestrant for ESR1-Mutated Breast Cancer

Shots: FDA has received NDA of vepdegestrant (ARV-471) to treat pts with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy NDA was backed by P-III (VERITAC-2) trial assessing ARV-471 alone vs fulvestrant in mentioned pts (n=624) previously treated with CDK4/6 inhibitor + endocrine therapy Trial showed improved PFS (1EP) by 43%…

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VIEWPOINTS_Angela Cacace_2024

Transformative Neurodegenerative Disorder Care: Angela Cacace in Conversation with PharmaShots

Shots: Angela Cacace Sr. VP, of Neuroscience and Platform Biology at Arvinas, shares insights from the preclinical trials evaluating ARV-102 for treatment of neurodegenerative diseases and dosing people with the first oral formulation (ARV-102) to treat neurodegenerative diseases ARV-102, a novel oral PROTAC® protein degrader, is designed to cross the blood-brain barrier and target leucine-rich repeat kinase…

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Know Your Investor (January Edition): RA Capital Management LLC  

Know Your Investor (January Edition): RA Capital Management LLC  

Shots:   New Year, New Us! Our hand-curated “Know Your Investor” reports will now be exploring leading investors of 2023   Founded in 2002, RA Capital forged ahead to become a key investor in life science and healthcare companies. In 2023, RA Capital closed 40 major investments in biopharma companies, devices, manufacturing, service offering firms, and diagnostics  …

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Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

Shots: The 41st Annual J.P. Morgan Healthcare Conference took place on 09 – 12 January 2023 in San Francisco, CA, USA. It is the largest and most informative healthcare investment symposium in the industry, bringing together a cohort of industry leaders, emerging fast-growing companies, innovative technology creators, and members of the investment community  The major announcement…

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