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News about Drug Discovery & Development
Hemispherian Secures FDA IND Clearance for First-in-Class Glioblastoma Therapeutic, GLIX1
Hemispherian AS has received FDA clearance for its IND application to begin a Phase 1 trial of GLIX1, a first-in-class small molecule targeting DNA repair vulnerabilities in glioblastoma and other solid tumours.
Drug Discovery & Development | 05/08/2025 | By Mrinmoy Dey | 399
EuMentis Therapeutics Secures US FDA Clearance of IND Application for EM-221
EuMentis Therapeutics has received FDA clearance to initiate a Phase 2 clinical trial of EM-221, its novel PDE10A inhibitor, for the treatment of schizophrenia.
Drug Discovery & Development | 31/07/2025 | By Mrinmoy Dey | 327
PharmNXT Acquires DTR to Bring European Bioprocess Manufacturing Expertise to India
In a major boost to India’s biopharmaceutical manufacturing landscape, Pune-based startup PharmNXT Biotech has acquired Ireland-based Defined Tubing Routing (DTR), a globally recognised innovator in advanced bioprocess tubing solutions.
Drug Discovery & Development | 28/07/2025 | By Darshana | 469
Godavari Biorefineries Secures Chinese Patent for Novel Anti-Cancer Molecule
Godavari Biorefineries Ltd., through its biotech arm Sathgen Therapeutics, has been granted a Chinese patent for its novel anti-cancer molecule HYDROXY-1,4-NAPHTHALENEDIONE.
Drug Discovery & Development | 22/07/2025 | By Mrinmoy Dey | 324
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 | 294
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 | 237
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 | 198
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 | 428
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 | 300
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 | 337
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