The China’s NMPA Grants Approval to Genesis Medtech’s Articulation Powered Stapler, iReach Omnia, for Complex Surgeries

BySenior EditorJanuary 3, 2025

Hanx Biopharmaceuticals Reports the First Patient Dosing with HX044 in P-I Clinical Evaluation

Shots: Hanx Biopharmaceuticals has dosed the first patient with HX044 under its P-I clinical evaluation for treating solid tumors The dose escalation & expansion P-I/IIa (HX044-I-01) trial will assess safety, tolerability, PK profile & initial efficacy of HX044 for the treatment of advanced solid tumor malignancies HX044 is a first-in-class bispecific antibody and…

PettureX Reports the Launch of AI Pet Health Scanner App, Addressing Pet Health

Shots: PettureX has reported the launch of its AI-based health scanning app, PettureX App, available through app stores in Jan 20, 2025, to enhance pet health monitoring The app enables pet owners detect health issues early through guided smartphone image scans of eyes, skin, or teeth. The AI provides real-time assessments and care recommendations,…

Chimerix Reports the Dordaviprone’s NDA Submission to the US FDA for Recurrent H3 K27M-Mutant Diffuse Glioma

Shots: Chimerix has submitted the NDA of dordaviprone (small molecule imipridone targeting the mitochondrial protease ClpP & dopamine receptor D2) to the US FDA, seeking accelerated approval for treating recurrent H3 K27M-mutant diffuse glioma Chimerix has also requested priority review along with a Rare Paediatric Disease PRV as a part of submission, as the…

Xgene Pharmaceutical Reports Results from P-IIb Trial of XG005 for Post-Surgical Pain

Shots: The P-IIb trial is evaluating XG005 (1250mg or 750mg, BID, oral) vs PBO in patients (n=450) for managing acute pain after bunionectomy Results showed reduced pain intensity over 72hrs. post-surgery, with mild pain (<4 NRS) in high dose group vs severe pain (>7 NRS) in PBO; delayed rescue medication use of up to…

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…

Pfizer Teminates the Deal to Develop Giroctocogene Fitelparvovec for Hemophilia A with Sangamo Therapeutics

Shots: Sangamo regains rights to giroctocogene fitelparvovec (gene therapy for hemophilia A) as Pfizer ends their collaboration (effective Apr 21, 2025) & decids not to file BLA or MAA to pursue commercialization. Sangamo plans to seek a new partner The drug is in P-III (AFFINE) trial involving 75 adult males with severe hemophilia A…

Galera Therapeutics Completes Nova Pharmaceuticals’ Acquisition

Shots: Galera has completed Nova’s acquisition to form Galera Therapeutics, trading on OTC under GRTX ticker. Acquisition was backed by a $3M investment from a group of investors led by Ikarian Capital Galera issued 21.1M common shares, pre-funded warrants for 23M shares & 119,318 Series B convertible preferred shares. At closing, Galera stockholders will…

ADC Therapeutics Reports Enrollment Completion in P-III (LOTIS-5) Study of Zynlonta Plus Rituximab for 2L+ Diffuse Large B-Cell Lymphoma

Shots: The patient enrollment in confirmatory P-III (LOTIS-5) study assessing Zynlonta + rituximab for treating 2L+ r/r DLBCL has been completed. Zynlonta was previously approved in 2021 under accelerated pathway for the same The study aims to convert accelerated approval & support label expansion to 2L+ with rituximab. Part 1 enrolled 20 patients for…

Brii Bio Signs an Agreement with VBI Vaccines to Acquire BRII-179’s IP Rights

Shots: Brii Bio & VBI Vaccines have signed an asset purchase agreement to acquire IP rights of BRII-179 (novel recombinant protein-based HBV immunotx., expressing Pre-S1, Pre-S2 & S HBV surface antigens) As per the terms, Brii will acquire BRII-179’s patents, know-how & associated materials for $18M (eliminating all future milestones & royalty obligations). Prior…