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Astex Pharmaceuticals Highlights Preclinical and Clinical Advances at EORTC-NCI-AACR Symposium

10/21/2024

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

2/24/2025

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

9/16/2024

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

10/28/2024

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

1/22/2025

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

10/29/2024

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

10/29/2024

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

10/29/2024

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

10/29/2024

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

5/16/2025

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

11/17/2024

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

11/21/2024

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

11/11/2024

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

11/14/2024

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

10/28/2024

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

10/28/2024

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

2/23/2025

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

11/1/2024

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

1/13/2025

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

6/5/2025

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.

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