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Gilead
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Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk
Shots: FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…
June 19, 20250Comments
VIEWPOINTS
Patient Characteristics Trends in CAR-T Therapies: Dr. Ira Zackon in a Stimulating Discussion with PharmaShots 
Shots:  In a retrospective study sourced from EHR data for DLBCL patients, groundbreaking insights were unearthed that could potentially shape the treatment landscape of CAR-T Therapies in DLBCL  Data from the 10-year study is divided into pre- and post-CAR-T eras to better reflect trends in patient demographics and disease progression  PharmaShots welcomes Dr. Ira Zackon,…
June 18, 20250Comments
News
Brain Navi Biotechnology Reports the US FDA’s 510(k) Clearance of NaoTrac for Neurosurgical Procedures
Shots: Brain Navi Biotechnology has received the US FDA’s 510(k) clearance for NaoTrac neurosurgical robot NaoTrac is a stereotaxic guiding surgical device that uses SMART tech for rapid, non-contact, frameless registration by aligning the pts anatomy with preoperative imaging, & a robotic arm to guide instruments while keeping the surgeon in control NaoTrac integrates AI…
June 18, 20250Comments
News
Avata Biosciences Enters a Co-Development and Licensing Deal with Oceanus Bio for AVAT-021 and AVAT-022 to Treat Epilepsy and Schizophrenia
Shots: Avata has entered into a co-development & licensing deal with Oceanus Bio for exclusive rights to AVAT-021 & AVAT-022 in Japan & Asia, excl. China & India As per the deal, Avata will receive $95M in co-development contributions, regulatory & sales milestones, plus double-digit royalties on sales, while Oceanus will lead regulatory activities &…
June 18, 20250Comments