Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)

Shots: FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026) BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…

ByRidhi RastogiJuly 17, 2025

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AstraZeneca Reports P-III (CARES) Trial Findings on Anselamimab for Light Chain Amyloidosis

Shots: AstraZeneca has reported P-III (CARES) trial findings assessing anselamimab (QW for 4wks. then Q2W till completion) + SoC vs PBO + SoC in pts (N=406) with stage IIIa (n=281) & stage IIIb (n=125) light chain (AL) amyloidosis Trial did not meet its 1EP of time to all-cause mortality & frequency of CV hospitalisations. However,…

ByRidhi RastogiJuly 16, 2025

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KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

Shots: The UK’s MHRA has approved Ekterly (sebetralstat) to treat hereditary angioedema (HAE) pts (≥12yrs.). Awaits approval in various global markets incl. the EU & Japan Approval was based on P-III (KONFIDENT) study assessing Ekterly (300mg & 600mg) vs PBO in 136 HAE pts (≥12yrs.) across 20 countries, which showed faster symptom relief, reduced attack severity &…

ByRidhi RastogiJuly 16, 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

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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

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Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)

Shots: Takeda has reported data from 2 P-III (FirstLight & RadiantLight) trials assessing oveporexton over 12wks. in NT1 pts, where FirstLight randomized 168 pts in 3 arms (high dose, low dose & PBO), while RadiantLight randomized 105 pts in 2 arms (high dose & PBO) Both studies showed improvements across all doses at Wk. 12…

ByRidhi RastogiJuly 14, 2025

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AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Shots: AstraZeneca has reported P-III (BaxHTN) trial findings on baxdrostat in pts with uncontrolled hypertension on two antihypertensives & those with resistant hypertension on ≥3 drugs, incl. a diuretic The P-III (BaxHTN) trial evaluated baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts over 12wks. At Wk. 24, 300 pts on…

ByRidhi RastogiJuly 14, 2025

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Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

Shots: The US FDA has approved Kerendia/Firialta (10, 20, & 40mg) for HF pts having a left ventricular ejection fraction (LVEF) of ≥40%, i.e. mildly reduced (HFmrEF) or preserved LVEF (HFpEF). Awaits authorization in China, EU & Japan, with global applications planned Approval was based on the P-III (FINEARTS-HF) trial, a part of P-III (MOONRAKER, n=15000) study, where…

ByRidhi RastogiJuly 14, 2025

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Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL

Shots: China’s NMPA has granted conditional approval to lisaftoclax for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have previously received ≥1 systemic therapy incl. BTK inhibitors Approval was based on pivotal P-II (APG2575CC201) trial assessing lisaftoclax monotx. in r/r CLL/SLL pts previously treated with BTK inhibitors &/or immunochemotherapy, which met its 1EP of improved…

ByRidhi RastogiJuly 14, 2025

NEWS

BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

Shots: The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy Approval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC pts Trial…

ByRidhi RastogiJuly 10, 2025

Bio-Thera Reports the US FDA’s BLA Acceptance of BAT2506 (Biosimilar, Simponi)

AstraZeneca Reports P-III (CARES) Trial Findings on Anselamimab for Light Chain Amyloidosis

KalVista Reports the MHRA Approval of Ekterly (Sebetralstat) for Treating Hereditary Angioedema

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

Takeda Reports P-III (FirstLight & RadiantLight) Trials Data on Oveporexton for Narcolepsy Type 1 (NT1)

AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Bayer Reports the US FDA’s Approval of Kerendia (Finerenone) to Treat Heart Failure (HF)

Ascentage Pharma Reports the NMPA’s Conditional Approval of Lisaftoclax for the Treatment of CLL/SLL

BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

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