Purpose Pharma’s Attrogy Secures the EC’s Approval for the Treatment of Hereditary Transthyretin-mediated Amyloidosis

Shots: The EC has approved Attrogy (diflunisal) to treat hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis) in adults with stage 1 or 2 polyneuropathy in all EEA states EC approval was based on a P-III trial showing that diflunisal significantly slowed disease progression in patients with TTR amyloidosis. At 24 mos. baseline, 1EP met diflunisal led to…

ByDipanshu DixitJuly 31, 2025

VIDEO

LIFE SCIENCES | DAILY NEWS | JUL 29, 2025 | PHARMASHOTS

ByDipanshu DixitJuly 29, 2025

NEWS

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

Shots: The CHMP has recommended to Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery but do not currently require radiotherapy or CT; anticipated EC decision in all 30 EEA states The CHMP opinion is based on the global P-III (INDIGO) trial (N=331), which included…

ByDipanshu DixitJuly 24, 2025

NEWS

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

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.),…

ByDipanshu DixitJuly 24, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2025

Shots: 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…

ByDipanshu DixitJuly 22, 2025

VIDEO

LIFE SCIENCES | DAILY NEWS | JUN 22, 2025 | PHARMASHOTS

ByDipanshu DixitJuly 22, 2025

NEWS

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Shots: The EC has approved Aucatzyl (Obecabtagene Autoleucel) for treating pts (≥26yrs.) with r/r B-ALL in all 30 EEA states The EC approval was based on the FELIX study (n=100+), which showed that pts in cohort IIA (n=94) receiving ≥1 infusion of obe-cel had a 76.6% CR/CRi rate, with a mDoR of 21.2mos. & mEFS…

ByDipanshu DixitJuly 21, 2025

INSIGHTS+

The US FDA New Drug Approvals in June 2025

Shots: 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…

ByDipanshu DixitJuly 15, 2025

NEWS

Sun Pharma Launches Leqselvi (Deuruxolitinib) to Treat Severe Alopecia Areata in the US

Shots: 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…

ByDipanshu DixitJuly 15, 2025

NEWS

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

Shots: 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…

ByDipanshu DixitJuly 15, 2025

Dipanshu Dixit

Purpose Pharma’s Attrogy Secures the EC’s Approval for the Treatment of Hereditary Transthyretin-mediated Amyloidosis

LIFE SCIENCES | DAILY NEWS | JUL 29, 2025 | PHARMASHOTS

Servier Reports the CHMP’s Positive Opinion Voranigo (Vorasidenib) to Treat Grade 2 IDH-Mutant Glioma

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

EMA Marketing Authorization of New Drugs in June 2025

LIFE SCIENCES | DAILY NEWS | JUN 22, 2025 | PHARMASHOTS

Autolus Therapeutics’ Aucatzyl Secures the EC’s Approval for R/R B-Cell Acute Lymphoblastic Leukemia (B-ALL)

The US FDA New Drug Approvals in June 2025

Sun Pharma Launches Leqselvi (Deuruxolitinib) to Treat Severe Alopecia Areata in the US

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

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