Astex Pharmaceuticals Highlights Preclinical and Clinical Advances at EORTC-NCI-AACR Symposium
Astex Pharmaceuticals is presenting preclinical data on ASTX528, a novel CBP/p300 HAT domain inhibitor, showcasing potent in vivo activity and a favorable safety profile.
FDA Issues Warning Letter to Jagsonpal Pharmaceuticals for Critical API Manufacturing Violations
The US FDA has issued a warning letter to Jagsonpal Pharmaceuticals citing significant deviations from Current Good Manufacturing Practice (CGMP) at its Rajasthan-based API facility following inspections in March-April 2024.
FDA Lifts Partial Clinical Hold on Zentalis' Azenosertib Studies
The FDA has lifted the partial clinical hold on Zentalis Pharmaceuticals' azenosertib studies, allowing the company to resume enrollment in ongoing clinical trials.
Sparrow Pharmaceuticals' Clofutriben Completes Phase 2 Trial and Receives FDA Orphan Drug Designation for Cushing's Syndrome
Sparrow Pharmaceuticals has completed its Phase 2 RESCUE trial of clofutriben for ACTH-dependent endogenous Cushing’s syndrome, with all eligible patients continuing treatment in an open-label extension.
Conduit Pharmaceuticals Teams with Agility Life Sciences to Advance Autoimmune Drug Formulations
Conduit Pharmaceuticals has established a strategic partnership with Agility Life Sciences to develop enhanced solid oral-dosage formulations for its autoimmune disease pipeline. The collaboration aims to optimize drug delivery while strengthening intellectual property protection through novel composition-of-matter patents.
Ketamir-2 Demonstrates Superior Efficacy Over Gabapentin in Chemotherapy-Induced Neuropathic Pain
MIRA Pharmaceuticals' Ketamir-2, a novel oral ketamine analog, shows 60% greater efficacy than gabapentin in preclinical models of chemotherapy-induced neuropathic pain.
Eledon's Tegoprubart Shows Promise in Type 1 Diabetes Islet Transplantation
Eledon Pharmaceuticals reports that tegoprubart, as part of an immunosuppression regimen, enabled insulin independence in two of three type 1 diabetes subjects after islet transplantation.
Eledon's Tegoprubart Shows Promise in Type 1 Diabetes Islet Transplantation
Eledon Pharmaceuticals reports that tegoprubart, combined with an immunosuppression regimen, enabled insulin independence in two of three T1D subjects post-islet transplant.
Eledon's Tegoprubart Shows Promise in Type 1 Diabetes Islet Transplantation
Eledon Pharmaceuticals' tegoprubart, as part of an immunosuppression regimen, enabled insulin independence in two of three type 1 diabetes subjects after islet transplantation.
Acadia Pharmaceuticals Wins Patent Infringement Case Against Aurobindo for Parkinson's Drug Nuplazid
A U.S. District Court ruled that Aurobindo Pharma infringes on two key patent claims held by Acadia Pharmaceuticals for its Parkinson's disease drug Nuplazid.
Ibezapolstat Shows Promise in Phase 2 Trial for Clostridioides difficile Infection
Acurx Pharmaceuticals presented Phase 2 trial data for ibezapolstat, an investigational antibiotic, at the Peggy Lillis Foundation Inaugural CDI Scientific Symposium.
FDA Grants Accelerated Approval to Jazz Pharmaceuticals' Ziihera for HER2-Positive Biliary Tract Cancer
The FDA granted accelerated approval to Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii) for HER2-positive biliary tract cancer (BTC) after prior treatment.
Alembic Pharmaceuticals Receives US FDA Approval for Diltiazem Hydrochloride Extended-Release Capsules
Alembic Pharmaceuticals has secured US FDA approval for Diltiazem Hydrochloride extended-release capsules (120 mg, 180 mg, 240 mg, 300 mg, and 360 mg).
Setmelanotide Shows Promise in Reducing Obesity in Young Children With Rare Genetic Deficiencies
A Phase 3 trial of setmelanotide in children aged 2-5 years with Bardet-Biedl syndrome or POMC, PCSK1, or LEPR deficiency demonstrated clinically meaningful reductions in BMI Z-score.
EyePoint's Duravyu Shows Promise in Phase 2 Trial for Diabetic Macular Edema
EyePoint Pharmaceuticals' Duravyu demonstrated significant improvement in visual acuity and retinal thickness in patients with diabetic macular edema (DME).
EyePoint's Duravyu Shows Promise in Phase 2 Trial for Diabetic Macular Edema
EyePoint Pharmaceuticals' Duravyu demonstrated early and sustained improvement in visual acuity and anatomical control in DME patients compared to aflibercept.
Telomir Pharmaceuticals Develops Novel Silver(II) Antimicrobial to Combat Drug-Resistant Infections
Telomir Pharmaceuticals has developed Telomir-Ag2, a stabilized Silver(II) complex showing potent activity against drug-resistant pathogens including MARSA, targeting the $30B+ antimicrobial market.
Prolong Pharmaceuticals' PP-007 Receives FDA Fast Track for Acute Ischemic Stroke
Prolong Pharmaceuticals' PP-007, a PEGylated carboxyhemoglobin, has been granted FDA Fast Track designation for acute ischemic stroke treatment.
Madrigal's Rezdiffra Shows Promise in MASH Cirrhosis with Two-Year Data
Madrigal Pharmaceuticals reports Rezdiffra (resmetirom) demonstrates potential benefits in patients with compensated MASH cirrhosis (F4c).
Kiniksa Pharmaceuticals Advances KPL-387 Phase 2/3 Trial for Recurrent Pericarditis
Kiniksa Pharmaceuticals announced the trial design for its Phase 2/3 clinical study of KPL-387, a monoclonal antibody targeting IL-1R1, in recurrent pericarditis patients.