News about Drug Discovery & Development

Clarity Secures FDA Fast Track Designation for 64Cu-SAR-bisPSMA

Clarity Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions.

Drug Discovery & Development | 23/08/2024 | By Aishwarya |  320

Dr. Reddy's, Aurigene and Kainomyx to Jointly Develop Affordable Anti-Malarial Drug

Under the MoU, Kainomyx has agreed to lead the technical strategy and associated aspects for drug discovery and clinical phases, Aurigene has agreed to focus on developing cost-effective and scalable drug chemistry, and while the program evolves, Dr. Reddy’s will bring in its regulatory and market access expertise.

Drug Discovery & Development | 22/08/2024 | By Aishwarya |  494

BerGenBio Partners with Tempus to Accelerate Development in STK11m Non-Small Cell Lung Cancer

BerGenBio's on-going BGBC016 Phase 1b/2a trial is designed to assess the benefit of adding bemcentinib to the current standard of care treatment (immunotherapy + doublet chemotherapy) in 1L STK11m patients, a population with poor outcomes and no specific therapies today.

Drug Discovery & Development | 21/08/2024 | By Aishwarya |  606

Glenmark Therapeutics Unveils Olopatadine Hydrochloride Ophthalmic Solution

Glenmark Therapeutics has launched Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1 percent (OTC) as compared to the active ingredient in Pataday Twice Daily Relief.

Drug Discovery & Development | 20/08/2024 | By Aishwarya |  635

Phanes PT217 Gets Orphan Drug Designation for Neuroendocrine Carcinoma

PT217 is a first-in-class bispecific antibody targeting delta-like ligand 3 (DLL3) and cluster of differentiation 47 (CD47) being developed for patients with NEC.

Drug Discovery & Development | 17/08/2024 | By Aishwarya |  488

Lupin Secures Tentative Approval from FDA for Brimonidine Tartrate Ophthalmic Solution

Lupin has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Brimonidine Tartrate Ophthalmic Solution, 0.025 percent (OTC).

Drug Discovery & Development | 16/08/2024 | By Aishwarya |  1049

Citius Pharma Subsidiary Acquires TenX Keane to Establish Citius Oncology

Citius Pharmaceuticals, Inc. has completed the previously announced merger of its oncology subsidiary with TenX Keane Acquisition (TenX).

Drug Discovery & Development | 14/08/2024 | By Aishwarya |  658

Evotec Announces Progress in its Collaboration with Bristol Myers Squibb

Evotec and Bristol Myers Squibb entered their strategic neuroscience collaboration in December 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases where there remains a significant unmet medical need for therapies that slow down or reverse disease progression.

Drug Discovery & Development | 12/08/2024 | By Aishwarya |  574

Alembic Pharma Secures US FDA Approval for Acitretin Capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Soriatane Capsules, 10 mg, 17.5 mg, and 25 mg, of Stiefel Laboratories, Inc. (Stiefel).

Drug Discovery & Development | 12/08/2024 | By Aishwarya |  1149

T-Maximum Pharmaceutical Announces Latest Clinical Advances in Allogeneic CAR-T Cell Therapy

T-MAXIMUM is currently focusing on advanced-stage solid malignancies, with its lead pipeline product for recurrent high-grade glioma (rHGG) demonstrating breakthrough efficacy and manageable safety in initial clinical studies and obtained Orphan Drug Designation (ODD) from the US FDA.

Drug Discovery & Development | 09/08/2024 | By Aishwarya |  757