News about Drug Discovery & Development

Thermo Fisher to Boost India's Biopharma Manufacturing with New Genome Valley Facilities

Thermo Fisher Scientific has announced major investments to strengthen India’s biopharma infrastructure, unveiling plans to establish two state-of-the-art facilities in Hyderabad’s Genome Valley by the end of 2025. The announcement was made during the Biopharma Conclave 2025, where company leaders engaged with government, industry, and academia.

Drug Discovery & Development | 21/08/2025 | By Darshana |  845

MedImpact to Launch Affordable Unbranded Biosimilar Ustekinumab-aekn in 2026

With specialty drug costs rising and many pharmacies closing, MedImpact’s strategy introduces a new sourcing model that provides pharmacies with access to lower prices while giving payers more flexibility and control over healthcare expenses. Importantly, this approach will extend beyond MedImpact’s own clients, offering broader industry-wide benefits.

Drug Discovery & Development | 20/08/2025 | By Darshana |  318

Gland Pharma Secures USFDA Approval for Norepinephrine Bitartrate in 5 Percent Dextrose Injection Bags

Gland Pharma Ltd. has received USFDA approval for its generic Norepinephrine Bitartrate in 5 percent Dextrose Injection, securing First-to-File status with 180 days of exclusivity in the US market.

Drug Discovery & Development | 16/08/2025 | By Mrinmoy Dey |  275

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 |  322

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 |  233

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 |  357

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 |  249

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 |  253

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 |  179

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 |  148