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News about Drug Discovery & Development
CDSCO Extends Online CoPP Submission Deadline to Support Pharma Exporters
The CDSCO also announced that it will conduct multiple zonal and subzonal training sessions to support stakeholders with the new system. State drug controllers have been instructed to guide manufacturers within their jurisdictions to begin submitting online from mid-August onwards.
Drug Discovery & Development | 21/07/2025 | By Darshana | 278
SK bioscience Submits IND Application for Phase 1/2 Trial of Adjuvanted Influenza Vaccine Candidate
SK bioscience has submitted an Investigational New Drug (IND) application to South Korea’s Ministry of Food and Drug Safety for Phase 1/2 clinical trials of its adjuvanted influenza vaccine candidate, NBP607B, aimed at boosting protection for older adults.
Drug Discovery & Development | 19/07/2025 | By Mrinmoy Dey | 221
Johnson & Johnson Secures US FDA Priority Review for TAR-200 NDA
Johnson & Johnson has announced that the US FDA has granted Priority Review to its New Drug Application for TAR-200, a first-of-its-kind intravesical gemcitabine-releasing system, for treating BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ.
Drug Discovery & Development | 18/07/2025 | By Mrinmoy Dey | 178
Thermo Fisher Scientific has announced an agreement to acquire Sanofi’s sterile fill-finish and packaging facility in Ridgefield, New Jersey, as part of a wider strategic partnership to strengthen drug product manufacturing in the United States. Financial details of the transaction remain undisclosed.
Drug Discovery & Development | 17/07/2025 | By Darshana | 409
The investigational therapy targets activating PI3Ka mutations, which are found in up to 40% of hormone receptor-positive (HR+)/HER2-negative advanced breast cancers and are implicated in a variety of solid tumors.
Drug Discovery & Development | 06/07/2025 | By Darshana | 272
CIPN is a common and often debilitating side effect of chemotherapy agents like platinum-based drugs, taxanes, and vinca alkaloids. It causes pain, tingling, and numbness in the extremities, potentially forcing dose reductions or treatment discontinuation, which can adversely impact patient outcomes.
Drug Discovery & Development | 03/07/2025 | By Darshana | 312
Moderna reports positive results from phase 3 efficacy study of P304 for seasonal influenza vaccine
In a previous phase 3 study, mRNA-1010 had already demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine.
Drug Discovery & Development | 02/07/2025 | By Darshana | 367
Iksuda Therapeutics Secures FDA IND Clearance for IKS014
Iksuda Therapeutics has received FDA clearance for its IND application for IKS014, a HER2-targeting antibody drug conjugate, paving the way for US site participation in its ongoing Phase 1 trial for advanced HER2-positive solid tumours.
Drug Discovery & Development | 02/07/2025 | By Mrinmoy Dey | 221
Lupin receives US FDA approval for loteprednol etabonate ophthalmic gel
Loteprednol etabonate ophthalmic gel, 0.38% is bioequivalent to Lotemax SM ophthalmic gel of Bausch & Lomb Inc. Lupin is the exclusive first-to-file for this product and is eligible for 180 days of generic drug exclusivity. This product will be manufactured at Lupin’s Pithampur facility in India.<br />
Drug Discovery & Development | 02/07/2025 | By Darshana | 304
Nona Biosciences has entered into a license agreement with Visterra, Inc. to accelerate the development of next-generation biotherapeutics for immune-mediated and autoimmune diseases using its proprietary HCAb Harbour Mice platform.
Drug Discovery & Development | 13/06/2025 | By Manvi | 169
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