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Advancing Lupus Research: Devon Kelly from Lupus Nexus in a Stimulating Conversation with PharmaShots

Advancing Lupus Research: Devon Kelly from Lupus Nexus in a Stimulating Conversation with PharmaShots

Shots:  Research into Lupus has yielded groundbreaking results in pharmacokinetics and pharmacodynamics, yet experts still don't understand its cause  Lupus Research Alliance (LRA) recently launched a platform called Data Repository, Exchange, and Analytics (DREAM) for data sharing and partnerships for research in lupus  Devon Kelly, Director of Lupus Nexus at the Lupus Research Alliance, sheds…

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Skye Bioscience & Arecor Therapeutics

Skye Bioscience Enters a Formulation Development Agreement with Arecor Therapeutics for Nimacimab

Shots: Skye Bioscience has partnered with Arecor Therapeutics to develop a higher concentration formulation of Skye’s nimacimab, leveraging Arecor’s Arestat formulation platform As per the deal, Skye will fund Arecor's development efforts, with the option to license rights of the new proprietary formulation & its intellectual property for further development & commercialization Nimacimab (CB1 inhibitor,…

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Inozyme Pharma

BioMarin Pharmaceutical to Acquire Inozyme Pharma for ~$270M, Strengthening its Enzyme Therapies Portfolio

Shots: BioMarin has entered into a definitive agreement to acquire Inozyme, strengthening its enzyme therapies portfolio with the addition of INZ-701, an enzyme replacement therapy As per the deal, Inozyme’s shareholders will receive $4.00 per share in an all-cash transaction for a total consideration of ~$270M; closing is expected in Q3’25 INZ-701 (SC) is being evaluated…

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GSK

GSK Receives the MHLW’s Approval for Blenrep (Belantamab Mafodotin) Regimens to Treat R/R Multiple Myeloma

Shots: MHLW has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy; review ongoing in the US (PDUFA: Jul 23, 2025), EU, Canada, China (PR for DREAMM-7), & Switzerland (with PR for DREAMM-8) Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep (2.5mg/kg, IV, Q3W) + BorDex vs Darzalex + BorDex in 494…

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PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)  

PharmaShots Weekly Snapshots (May 12, 2025 – May 16, 2025)   This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A & Animal Health. Check out our full report below:       Johnson & Johnson Reveals P-III (ICONIC-TOTAL) Trial Data of Icotrokinra for Plaque Psoriasis  Read More: J&J  AstraZeneca Reports…

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BioCryst

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada NDA was supported by P-III (APeX-P) trial assessing Orladeyo…

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