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GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

Shots: The Japanese MHLW has accepted the NDA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) NDA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in pts from 29 countries for the treatment of CHB Trials showed statistically significant &…

3 days ago

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Shots: The US FDA has accepted sNDA & granted priority review to olezarsen for the treatment of severe hypertriglyceridemia (sHTG), with a PDUFA action date of Jun 30, 2026 sNDA was backed by the P-III (CORE: n=617 & CORE2: n=446) trials assessing olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults…

3 days ago

Galderma Announces OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis

Shots: Galderma has reported OLYMPIA LTE study data assessing Nemluvio in 508 pts with prurigo nodularis up to 4yrs., from the P-II trial & the P-III (OLYMPIA 1 & 2) trials At Wk. 148, >70% of pts had clear or almost clear lesions per IGA score, >85% achieved ≥75% of healed lesions by prurigo activity…

3 days ago

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

Shots: Bayer has reported the P-III (PEACE-3) trial assessing Xofigo (radium-223 dichloride; 55kBq/kg, IV, QM for 6 cycles) + enzalutamide (160mg, PO, QD) vs enzalutamide in asymptomatic or mildly symptomatic pts (Brief Pain Inventory score <4) with mCRPC & ≥2 bone metastases Trial showed improved OS (2EP), with a 24% reduction in death risk &…

3 days ago

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Shots: The US FDA has granted accelerated approval to Hernexeos (zongertinib) for the 1L treatment of pts with advanced NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations Approval was based on the data from a treatment-naïve cohort (N=72) of the P-Ib (Beamion LUNG-1) trial assessing Hernexeos as monotx., which showed improved ORR of 76% (11%…

3 days ago

Boehringer Ingelheim Inks $500M+ Deal with Sitryx Therapeutics for Novel Oral Immune Disease Therapies

Shots: Sitryx Therapeutics has granted BI an exclusive license to a preclinical, small molecule program, offering a disease-modifying treatment approach across multiple autoimmune & inflammatory disease indications As per the deal, BI will receive an exclusive global license to the multiple assets & related IP to the small molecule inhibitor program, plus it will assume…

3 days ago

Cara Medical Reports 510(k) clearance of CARA System for Noninvasive Cardiac Conduction System Visualization

Shots: The US FDA has granted 510(k) clearance to CARA System for non-invasive, patient-specific 3D visualization of the cardiac conduction system, with commercialization to begin in the coming mos. The CARA System combines the CARA MetisTM Simulator, a preprocedural CTA-based simulator to create a personalized 3D map of the cardiac conduction system, with the CARA…

4 days ago

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

Shots: The Chinese NMPA has accepted NDA & granted priority review to linerixibat, an IBAT inhibitor, for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) pts; regulatory review is ongoing in the US, EU, UK & Canada NDA was supported by P-III (GLISTEN) trial assessing linerixibat (40mg) vs PBO to treat PBC pts…

4 days ago

Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs

Shots: The US FDA has approved Numelvi (Atinvicitinib) for the control of pruritus associated with allergic dermatitis in dogs (≥6mos.), with availability expected in spring 2026 Numelvi is a second-generation JAK inhibitor supplied in easy-to-dispense bottles and designed for convenient storage under standard conditions. Numelvi is ≥10-fold more selective for JAK1 over JAK2, JAK3 &…

4 days ago

ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

Shots: ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…

4 days ago

NEWS

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

Ionis’ Olezarsen sNDA Secures the US FDA Priority Review for Severe Hypertriglyceridemia

Galderma Announces OLYMPIA Extension Study Data on Nemluvio for Prurigo Nodularis

Bayer Reports P-III (PEACE-3) Trial Data on Xofigo Combination for Metastatic Castration-Resistant Prostate Cancer (mCRPC) with Bone Metastases

The US FDA Grants Accelerated Approval to Boehringer Ingelheim’s Hernexeos for 1L HER2-Mutant NSCLC

Boehringer Ingelheim Inks $500M+ Deal with Sitryx Therapeutics for Novel Oral Immune Disease Therapies

Cara Medical Reports 510(k) clearance of CARA System for Noninvasive Cardiac Conduction System Visualization

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

Merck Animal Health’s Numelvi Secures the FDA Approval for Control of Pruritus Associated with Allergic Dermatitis in Dogs

ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

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