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NEWS

Simpson Interventions Receives the US FDA’s 510(k) Clearance for its Shadow Catheter and IDE Approval for its Acolyte Catheter System

Shots: Simpson Interventions reported the grant of IDE by the US FDA to Acolyte Image-Guided Crossing & Re-Entry Catheter System plus 510(k) clearance for its Shadow Catheter Acolyte System intends to enables cardiologists with revascularization of coronary chronic total occlusion (CTO). In Mar 2024, it was designated with the US FDA’s BDD and included…
January 8, 2025

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GSK
NEWS

GSK’s GSK’227 Secures the US FDA’s Breakthrough Therapy Designation for Treating Late-Line R/R Osteosarcoma

Shots: The US FDA has granted BTD to GSK5764227 (GSK’227) for treating r/r osteosarcoma in patients with disease progression on at least 2 prior lines of therapy Designation was supported by P-II (ARTEMIS-002) trial (carried out by Hansoh Pharma) assessing the safety & efficacy of GSK’227 to treat patients (n=60; 42 had osteosarcoma) with…
January 7, 2025

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NEWS

Fortress Biotech and Cyprium Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of CUTX-101 to Treat Menkes Disease

Shots: Fortress and its subsidiary, Cyprium, have reported the US FDA’s NDA acceptance & priority review of CUTX-101 (copper histidinate) to treat Menkes disease, with the decision expected on Jun 30, 2025 Submission was based on a trial of CUTX-101 vs untreated historical control that depicted significantly improved OS & an 80% reduction in…
January 7, 2025

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NEWS

NMD Pharma’s NMD670 Secures the US FDA’s Orphan Drug Designation to Treat Charcot-Marie-Tooth Disease

Shots: The US FDA has granted ODD to NMD670 for treating Charcot-Marie-Tooth disease (CMT). It is small molecule that inhibits CIC-1 to enhances muscle responsiveness, improving neuromuscular transmission & restoring function NMD670 (PO, BID) is under P-IIa (SYNAPSE-CMT) evaluation for its efficacy, safety & tolerability in adults (n=80) with CMT1 or CMT2 subtype for over…
January 6, 2025

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NEWS

MicuRx Pharmaceutical’s MRX-5 Secures the US FDA’s Orphan Drug Designation for Treating NTM Infections

Shots: The US FDA has granted orphan drug designation (ODD) to MRX-5 for treating non-tuberculous mycobacteria (NTM) infections MRX-5 is a new drug for drug-resistant NTM infections, showing strong antibacterial activity, favorable safety & PK profile in both animal studies & human trial. With minimal interactions, low resistance potential & high oral bioavailability, it…
January 2, 2025

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NEWS

Corcept Therapeutics Reports NDA Submission of Relacorilant to the US FDA for Treating Hypercortisolism

Shots: Corcept has submitted NDA of relacorilant to the US FDA for the treatment of endogenous hypercortisolism (Cushing’s syndrome) Submission was based on pivotal GRACE study, confirmatory P-III (GRADIENT) & long-term extension trials plus P-II hypercortisolism trial. Relacorilant showed improved symptoms without adrenal insufficiency, hypokalemia, QT prolongation, or progesterone receptor-related AEs (endometrial thickening or…
January 1, 2025

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xbrane
NEWS

Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate 

Shots:  Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024  The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing…
December 31, 2024

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BMS
NEWS

BMS’ Opdivo Qvantig SC Injection Secures the US FDA’s Approval for Solid Tumor Opdivo Indications 

Shots:    The US FDA has approved Opdivo Qvantig (nivolumab & hyaluronidase-nvhy) SC injection for previously approved solid tumor Opdivo indications, incl. as monotx., maintenance therapy after Opdivo-Yervoy combination & with CT or cabozantinib  Approval was based on P-III (CheckMate-67T) study assessing Opdivo Qvantig (nivolumab: 1,200mg & hyaluronidase: 20,000 units, SC, Q4W; n=248) vs Opdivo (3mg/kg,…
December 27, 2024

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BeiGene
NEWS

BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers 

Shots:    The US FDA has approved Tevimbra + Pt & fluoropyrimidine-based CT as a 1L treatment of inoperable or metastatic HER2- G/GEJ adenocarcinoma with PD-L1 (≥1) expression. Another BLA for 1L locally advanced unresectable or metastatic ESCC is under review  Approval was based on P-III (RATIONALE-305) study of Tevimbra + CT vs PBO in patients…
December 26, 2024

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NEWS

Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia 

Shots:  Bio-Thera Solutions has collaborated with Tabuk Pharmaceuticals to commercialize BAT2206, biosimilar of Stelara (Ustekinumab) in Saudi Arabia  The alliance will utilize Tabuk's local footprint, sales & marketing abilities, with Tabuk handling marketing, registration, manufacturing & promotion of BAT2206. Bio-Thera will manage development & supply from its Guangzhou manufacturing facilities  BAT2206, a proposed biosimilar to…
December 24, 2024

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