Eton Pharmaceuticals Receives FDA Approval for KHINDIVI, First Hydrocortisone Oral Solution for Pediatric Adrenal Insufficiency
Eton Pharmaceuticals announced FDA approval of KHINDIVI (hydrocortisone) oral solution, marking the first and only FDA-approved liquid hydrocortisone formulation for pediatric patients aged 5 and older with adrenocortical insufficiency.
Delta-Fly Pharma Advances Solid Tumor and Pancreatic Cancer Programs
Delta-Fly Pharma's DFP-14927, a drug delivery formulation of DFP-10917, is undergoing an expanded Phase I study in R/R colorectal cancer patients at MD Anderson and UCLA.
Recce Pharmaceuticals' R327G Shows 93% Efficacy in Phase II Trial for Bacterial Skin Infections
Recce Pharmaceuticals' R327G topical gel achieved a 93% primary efficacy endpoint in treating acute bacterial skin and skin structure infections (ABSSSI) and diabetic foot infections (DFI).
Ocugen Doses First Patient in Phase 1 Trial of OCU200 for Diabetic Macular Edema
Ocugen has initiated a Phase 1 clinical trial for OCU200, a novel integrin-targeting biologic, in patients with diabetic macular edema (DME).
Intas Pharmaceuticals Receives CDSCO Panel Approval for Phase III Trial of R-hFSH
• Intas Pharmaceuticals has been granted permission by the CDSCO's Subject Expert Committee to proceed with a Phase III clinical trial for its R-hFSH solution for injection. • The trial will assess the safety, efficacy, and immunogenicity of Intas' R-hFSH compared to Merck Serono's Gonal-F in adult females undergoing assisted reproductive technology. • The CDSCO panel recommended including more tertiary care centers and government sites in the Phase III clinical trial to ensure a diverse study population. • R-hFSH, a recombinant human follicle-stimulating hormone, is crucial for ovarian follicular growth in women and spermatogenesis in men with specific hormonal deficiencies.
Zanidatamab Shows Promise in HER2-Positive Gastroesophageal and Colorectal Cancers
Jazz Pharmaceuticals presented updated Phase 2 data at ESMO 2024 for zanidatamab plus chemotherapy in HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA).
Rocket Pharma Completes Enrollment in Phase 2 Trial of RP-A501 for Danon Disease
Rocket Pharmaceuticals has completed enrollment in its Phase 2 pivotal trial of RP-A501 for male patients with Danon disease.
Enanta's EDP-323 Shows Strong Efficacy in RSV Human Challenge Trial
Enanta Pharmaceuticals' EDP-323 demonstrated significant viral load reduction in a Phase 2a human challenge trial for Respiratory Syncytial Virus (RSV).
Alnylam's ALN-HTT02: First Patient Dosed in Phase 1 Huntington's Disease Trial
Alnylam Pharmaceuticals initiated a Phase 1 clinical trial for ALN-HTT02, a novel RNAi therapeutic targeting the huntingtin (HTT) gene for Huntington's disease (HD).
Kira Pharmaceuticals' KP104 Shows Sustained Efficacy and Safety in PNH Phase 2 Trial
KP104, a dual-targeting complement inhibitor, demonstrates long-term safety and efficacy in complement inhibitor-naïve PNH patients.
Identiv and Novanta Partner to Advance RFID Technology in Medical Devices and Pharmaceuticals
Identiv and Novanta have formed a strategic partnership to develop integrated RFID solutions for medical device manufacturers, combining Identiv's RFID inlays with Novanta's ThingMagic reader technology.
Senores Pharmaceuticals Acquires 14 ANDAs from Dr. Reddy's in $421M Market Opportunity Deal
Gujarat-based Senores Pharmaceuticals has strategically acquired 14 Abbreviated New Drug Applications from Dr. Reddy's Laboratories, with 13 already FDA-approved and one pending approval.
Processa Pharmaceuticals Doses First Patient in Phase II Trial of NGC-Cap for Metastatic Breast Cancer
Processa Pharmaceuticals has dosed the first patient in a Phase II clinical trial of Next Generation Capecitabine (NGC-Cap) for advanced or metastatic breast cancer.
Ganaxolone Shows Promise in Phase III RAISE Trial for Refractory Status Epilepticus
Marinus Pharmaceuticals' RAISE trial evaluated IV ganaxolone for refractory status epilepticus (RSE), meeting one co-primary endpoint.
Arrowhead Pharmaceuticals Launches First-in-Human Trial of ARO-ALK7 for Obesity Treatment
Arrowhead Pharmaceuticals has dosed the first subjects in a Phase 1/2a clinical trial of ARO-ALK7, marking the first investigational RNAi therapeutic to target a gene expressed in adipose tissue for obesity treatment.
Rhythm Pharmaceuticals' Imcivree Shows Significant Weight Loss in Phase III Hypothalamic Obesity Trial
Rhythm Pharmaceuticals' Imcivree (setmelanotide) demonstrated a 19.8% placebo-adjusted reduction in BMI over 52 weeks in patients with acquired hypothalamic obesity, a rare condition caused by hypothalamic damage.
Meitheal Pharmaceuticals Launches Generic Abraxane in US Market to Address Cancer Treatment Access
Meitheal Pharmaceuticals has launched paclitaxel protein-bound particles for injectable suspension, a generic version of Abraxane, through an exclusive licensing agreement with parent company Hong Kong King-Friend Industry.
GSK Acquires Efimosfermin Alfa from Boston Pharmaceuticals in $2 Billion Deal for Liver Disease Treatment
GSK has agreed to acquire efimosfermin alfa, a phase III-ready liver disease drug, from Boston Pharmaceuticals in a deal worth up to $2 billion.
Foresee Pharmaceuticals Redirects Mirivadelgat Development to PH-ILD Following Fanconi Anemia Trial Challenges
Foresee Pharmaceuticals has terminated its Phase 2 trial of mirivadelgat for Fanconi anemia due to significant patient recruitment challenges and shifting research priorities in the field.
Rivus Pharmaceuticals' HU6 Shows Muscle-Sparing Weight Loss in HFpEF Trial
Rivus Pharmaceuticals' HU6 demonstrated statistically significant reductions in fat mass and visceral fat in obese patients with heart failure with preserved ejection fraction (HFpEF).