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

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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

NEWS

PRN Pharmacal Receives the Full US FDA Approval for KBroVet to Control Seizures in Dogs with Idiopathic Epilepsy

Shots: The US FDA has granted full approval to KBroVet (potassium bromide chewable tablets) under NADA for the control of seizures associated with idiopathic epilepsy in dogs KBroVet offers benefits for dogs, incl. renal excretion via glomerular filtration for those with liver issues, once-daily dosing, & flavored, chewable tablets formulated specifically for dogs KBroVet has a…

ByRidhi RastogiFebruary 13, 2026

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Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

Shots: The US FDA has granted 510(k) clearance to Encora X1 to help relieve hand tremors in the treated limb during stimulation in adults with essential tremor Clearance was backed by a sham-controlled trial & a 90-day home-use study, both demonstrating improvements in tremor severity & functional tasks, supporting the device’s ability to assist with…

ByRidhi RastogiFebruary 13, 2026

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The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Shots: The EC has approved Uplizna (inebilizumab) as an add-on treatment of anti-AChR & anti-MuSK antibody positive adults with gMG Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading doses followed by 2 doses/year Pts on steroids began tapering at Wk. 4,…

ByRidhi RastogiFebruary 13, 2026

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Adlai Nortye Doses First Patient in the P-I Trial of AN9025 to Treat Solid Tumors Harboring RAS Mutations

Shots: Adlai Nortye has dosed the first patient in the US with AN9025 in its ongoing P-I trial for the treatment of advanced or metastatic solid tumors harboring RAS mutations Trial is being conducted by Adlai Nortye with ASK Pharm as a multi-regional study under a license agreement granting Adlai Nortye ex-China rights to AN9025,…

ByRidhi RastogiFebruary 12, 2026

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Lotus Pharmaceutical Partners with Formycon to Commercialize FYB206 (Biosimilar, Keytruda) across APAC Region

Shots: Formycon & Lotus have reported the conclusion of their exclusive license agreement for Formycon’s FYB206, a biosimilar version of Keytruda (Pembrolizumab), in the APAC market Upon closing, Formycon will receive an upfront payment, plus potential development & regulatory milestone payments, & a share of gross profits after launch, while retaining responsibility for manufacturing &…

ByRidhi RastogiFebruary 12, 2026

NEWS

Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

Shots: The US FDA has granted IND Clearance to initiate P-II PoC trial of AK3280 in the US for the treatment of idiopathic pulmonary fibrosis (IPF) The P-II PoC trial will evaluate AK3280 (PO) vs PBO & an active comparator in IPF pts, aiming to generate key clinical data to support future regulatory filings &…

ByRidhi RastogiFebruary 12, 2026

Ridhi Rastogi

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

PRN Pharmacal Receives the Full US FDA Approval for KBroVet to Control Seizures in Dogs with Idiopathic Epilepsy

Encora Therapeutics’ Encora X1 Gains the US FDA 510(k) Clearance for Essential Tremor

The EC Approves Amgen’s Uplizna (Inebilizumab) to Treat Generalized Myasthenia Gravis (gMG)

Adlai Nortye Doses First Patient in the P-I Trial of AN9025 to Treat Solid Tumors Harboring RAS Mutations

Lotus Pharmaceutical Partners with Formycon to Commercialize FYB206 (Biosimilar, Keytruda) across APAC Region

Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

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