News about Drug Discovery & Development

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 |  474

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 |  921

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 |  630

Amneal Pharma Gets US FDA Approval for CREXONT Extended-Release Capsules

CREXONT is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets.

Drug Discovery & Development | 08/08/2024 | By Aishwarya |  900

Lupin Gets Approval from US FDA for Prednisolone Acetate Ophthalmic Suspension

Lupin has secured approval from US FDA for its Abbreviated New Drug Application (ANDA) for Prednisolone Acetate Ophthalmic Suspension USP, 1 percent to market a generic equivalent of Pred Forte Ophthalmic Suspension, 1 percent, of AbbVie Inc.

Drug Discovery & Development | 07/08/2024 | By Aishwarya |  631

Lupin Completes Phase 3 Trials for Lucentis Biosimilar

Lupin has successfully completed a global Phase 3 clinical study of LUBT010, its biosimilar candidate to Lucentis.

Drug Discovery & Development | 06/08/2024 | By Aishwarya |  674

Alembic Pharma Gets USFDA Final Approval for Nelarabine Injection

Alembic Pharmaceuticals has secured final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Nelarabine Injection, 250 mg/50 mL (5 mg/mL) (Single-Dose Vial).

Drug Discovery & Development | 05/08/2024 | By Aishwarya |  610

Inoviv Introduces MasterKey for Multiplexed Targeted Protein Assays

Inoviv has developed MasterKey, which enables researchers to select specific proteins from a comprehensive, pre-characterized catalog of thousands of proteins.

Drug Discovery & Development | 01/08/2024 | By Aishwarya |  563

Zydus Gets Approval from COFEPRIS to Market Mamitra

Zydus Lifesciences has announced that COFEPRIS (Federal Commission for the Protection Against Sanitary Risk) has granted marketing approval for Mamitra, a Trastuzumab biosimilar.

Drug Discovery & Development | 31/07/2024 | By Aishwarya |  766

OneSource Signs Licensing Deal with BRL to Deliver High-Concentration Biologic Products

OneSource Specialty Pharma Ltd. has signed a strategic licensing agreement with Bhami’s Research Laboratory (BRL).

Drug Discovery & Development | 30/07/2024 | By Aishwarya |  798