Eli Lilly Reports P-III (LIBRETTO-432) Trial Findings on Retevmo (Selpercatinib) in RET Fusion-Positive NSCLC

Shots: Eli Lilly has reported P-III (LIBRETTO-432) trial data assessing Retevmo vs PBO in 151 pts with RET fusion-positive NSCLC following completion of definitive radiotherapy or surgery with curative intent, & other adjuvant therapy, if indicated Trial met its 1EP, showing improvement in investigator-assessed EFS in early-stage (II-IIIA) pts, plus OS data was immature but demonstrated a…

ByRidhi RastogiFebruary 17, 2026

NEWS

LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

Shots: The US FDA has granted 510(k) clearance & CLIA waiver to VELO system for highly sensitive PCR results for respiratory pathogens LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 respiratory season, with US commercial activities anticipated in 2026 VELO system allows multiplex PCR testing for respiratory…

ByRidhi RastogiFebruary 16, 2026

NEWS

Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)

Shots: The US FDA has granted IND clearance to initiate P-I trial of HLX15-SC, a biosimilar version of Darzalex Faspro (daratumumab), for the 1L treatment of multiple myeloma In Jun 2024, the P-I study of HLX15 (IV; Biosimilar, Darzalex) met its 1EP, demonstrating similar PK & comparable safety & immunogenicity to US, EU, & China-sourced…

ByRidhi RastogiFebruary 16, 2026

NEWS

InnoCare Pharma Reports First Patient Dosing in P-II/III Trial of Soficitinib for Chronic Spontaneous Urticaria

Shots: InnoCare has dosed the first patient with soficitinib (ICP-332) in the P-II/III trial for the treatment of chronic spontaneous urticaria Additionally, the company has completed enrolment in soficitinib’s P-III trial for mod. to sev. atopic dermatitis & P-II trial for vitiligo Soficitinib (ICP-332) is a selective TYK2 inhibitor in development for T-cell–mediated autoimmune diseases,…

ByRidhi RastogiFebruary 16, 2026

NEWS

Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Shots: Genentech has reported the P-III (MAJESTY) trial results assessing Gazyva vs tacrolimus in 142 pts with primary membranous nephropathy Trial met its 1EP, showing higher CR at Wk. 104 & achieved its key 2EPs, incl. improved overall remission & CR at Wks. 104 & 76, respectively; data to be presented in the future &…

ByRidhi RastogiFebruary 16, 2026

NEWS

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

Shots: Lundbeck has reported P-IIb (PROCEED) trial results evaluating bocunebart (SC/IV; QM for 3mos.) vs PBO in migraine patients with prior failure of 1-4 preventive therapies, with the IV arm randomizing 431 pts across 14 countries Trial met its 1EP in the multiple IV dosing arm, showing a statistically significant reduction in monthly migraine days…

ByRidhi RastogiFebruary 16, 2026

NEWS

STADA & Bio-Thera Receive the EC approval for Gotenfia (Biosimilar, Simponi)

Shots: The EC has approved STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), in all 30 EEA states, with launch preparations ongoing Approval was based on extensive analytical, non-clinical & clinical data demonstrating biosimilarity of BAT2506 to Simponi In May 2024 deal, STADA obtained exclusive commercial rights to Gotenfia…

ByRidhi RastogiFebruary 16, 2026

NEWS

Novartis Reports Final P-III (ALIGN) Trial Data on Vanrafia (Atrasentan) in IgA Nephropathy (IgAN)

Shots: The global P-III (ALIGN) trial assessed Vanrafia (0.75mg, QD, PO) vs PBO for 132wks. in 340 IgAN pts at risk of progressive loss of kidney function. An additional 64 pts received an SGLT2 inhibitor alongside a RAS inhibitor for at least 12wks. In the trial, Vanrafia showed a 2.39 mL/min/1.73m² difference in eGFR change…

ByRidhi RastogiFebruary 13, 2026

NEWS

EYE PCR’s fixOflex Receives CE Mark for Posterior Capsule Opacification, Advancing Cataract Surgery Innovation

Shots: EYE PCR has received the CE Mark under EU MDR for fixOflex endocapsular device for use during cataract surgery fixOflex has shown comparable safety to standard cataract surgery in a study of 121 pts, with 0.83% PCO incidence at 12mos. vs 13% in a retrospective control group, & no Nd:YAG capsulotomies required compared to…

ByRidhi RastogiFebruary 13, 2026

NEWS

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings on Breztri Aerosphere for Uncontrolled Asthma

Shots: The P-III (LOGOS & KALOS) trials evaluated Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts with uncontrolled asthma; Regulatory filings in asthma are under review in all major regions In pooled analysis, Breztri improved lung function by 76 mL in morning pre-dose trough…

ByRidhi RastogiFebruary 13, 2026

Ridhi Rastogi

Eli Lilly Reports P-III (LIBRETTO-432) Trial Findings on Retevmo (Selpercatinib) in RET Fusion-Positive NSCLC

LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

Henlius Reports the FDA IND Clearance to Initiate P-I Trial of HLX15-SC (Biosimilar, Darzalex Faspro)

InnoCare Pharma Reports First Patient Dosing in P-II/III Trial of Soficitinib for Chronic Spontaneous Urticaria

Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Lundbeck Reports Topline P-IIb (PROCEED) Trial Results on Bocunebart in Migraine Prevention

STADA & Bio-Thera Receive the EC approval for Gotenfia (Biosimilar, Simponi)

Novartis Reports Final P-III (ALIGN) Trial Data on Vanrafia (Atrasentan) in IgA Nephropathy (IgAN)

EYE PCR’s fixOflex Receives CE Mark for Posterior Capsule Opacification, Advancing Cataract Surgery Innovation

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings on Breztri Aerosphere for Uncontrolled Asthma

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