Dipanshu Dixit
Shots:
Health Canada has approved Blenrep + BorDex & PomDex in MM pts with ≥1 prior therapy
Approval was based on P-III (DREAMM-7 & DREAMM-8) trials assessing Blenrep + BorDex vs Darzalex + BorDex in 494 pts & Blenrep + PomDex (BPd) vs Velcade + PomDex in 302 pts, respectively
DREAMM-7 showed improved PFS (1EP; mPFS: 36.6 vs 13.4mos.),…
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The EMA’s CHMP has granted positive opinions and approvals to 2 Biologics and 6 new chemical entities in June 2025, leading to treatments for patients and advances in the healthcare industry
The major highlighted drug was SpringWorks Therapeutics’ Ogsiveo to Treat Desmoid Tumours
PharmaShots has compiled a list of 8 drugs that have been…
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PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025
The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry
The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing…
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Sun Pharma has launched Leqselvi (deuruxolitinib; 8mg) for the treatment of pts with severe alopecia areata in the US
FDA Approval was based on 2 P-III (THRIVE-AA1 & THRIVE-AA2) trials that assessed the scalp hair regrowth using the SALT score with Leqselvi (8 or 12mg, BID) vs PBO in adults (n=1223; 18-65yrs.) with severe alopecia areata…
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Merck has initiated P-III (EXPrESSIVE-11) trial to evaluate MK-8527 (QM) vs FTC/TDF for HIV PrEP in ~4,390 individuals at higher risk across 16 countries (enrolment from Aug 2025), & will begin the P-III (EXPrESSIVE-10) trial in ~4,580 women (16-30yrs.) in sub-Saharan Africa, with enrolment starting in the next few mos.
Decision to initiate P-III…
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Health Canada has approved label expansion of Evkeeza, as an adjunct to diet & other lipid-lowering therapies, to treat children (≥6mos.) with HoFH
Approval was based on model-based analysis that predicted similar or greater LDL-C reductions with Evkeeza (15mg/kg, Q4W) in children (6mos. to 5yrs.) at 24wks. Data from compassionate use in 5 children…
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Eolas Therapeutics has secured full development rights from AstraZeneca for AZD4041 to treat opioid use disorder (OUD) and other substance use disorders; terms remain confidential
As per the agreement, Eolas will take full responsibility for AZD4041 under the existing IND and advance it to P-II trials with NIDA UG3 support, focusing on a patient-centered…
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The US FDA has approved Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension), a once-yearly injectable for flea and tick protection in dogs, will be available in U.S. veterinary clinics by Aug, 2025
Bravecto Quantum kills adult fleas and controls flea and tick infestations (Ixodes scapularis, Dermacentor variabilis, Rhipicephalus sanguineus) for 12 mos., and Amblyomma…