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INSIGHTS+
New Drug Designations – May 2025  
Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA    The May 2025 report covers designations granted to 44 drugs and 5 medical devices, spanning 15 small molecules, 7 biologics, 13 cell and gene therapies & 5 medical devices among others   …
June 24, 20250Comments
News
DARZALEX (Daratumumab) Receives Positive CHMP Opinion for High-Risk Smouldering Multiple Myeloma
Shots: Janssen-Cilag (Johnson & Johnson) announced that the CHMP of the EMA has recommended approving DARZALEX (daratumumab) SC as the first therapy for adults with high‑risk smouldering multiple myeloma (SMM) The CHMP’s recommendation is based on the P-III (AQUILA) study data evaluating efficacy and safety of fixed-duration monotx. daratumumab SC compared with active monitoring (N=390)…
June 24, 20250Comments
News
Johnson & Johnson launches ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Contact Lens in the US and Canada
Shots: Johnson & Johnson launched ACUVUE OASYS MAX 1‑DAY MULTIFOCAL for astigmatism daily disposable lens in the U.S. and Canada for people with both astigmatism and presbyopia A study showed 95% of people wearing ACUVUE OASYS MAX 1-DAY MULTIFOCAL for ASTIGMATISM contact lenses reported clear vision during daily activities, while 87% saw clearly while driving…
June 24, 20250Comments
THOUGHTSPOT
Precision Medicine in Cancer Treatment: Revolutionizing Patient Care Through Personalized Approaches
Precision medicine has emerged as a transformative approach in cancer treatment, moving away from the traditional one-size-fits-all methodology toward highly individualized therapeutic strategies. This paradigm shift recognizes that each patient's cancer is unique, with distinct genetic profiles, molecular characteristics, and treatment responses that require tailored approaches. By leveraging advanced genomic technologies, biomarker identification, and sophisticated…
June 24, 20250Comments
Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots
VIEWPOINTS
Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots
Shots:  At ASH 2024, Regeneron shared data from the P-III exploratory cohort investigating the pozelimab and cemdisiran combination (poze-cemdi) in patients with paroxysmal nocturnal hemoglobinuria  The novel combination (poze-cemdi) achieved meaningful control of intravascular hemolysis compared to ravulizumab   PharmaShots welcomes Lorah Perlee, Vice President, Global Program Head, Hematology and Translational Sciences at Regeneron, for an…
June 23, 20250Comments