News about Drug Discovery & Development

CDSCO Clarifies Regulatory Pathway: Cocrystals of Approved Drugs to Be Treated as New Drugs

The Central Drugs Standard Control Organisation (CDSCO) has issued a clarification stating that cocrystals of already approved active substances will be treated as new drugs under Indian regulations.

Drug Discovery & Development | 17/09/2025 | By Darshana |  425

Roche Pharma India Expands AIR Initiative to Boost Clinical Trial Capacity

Roche Pharma India has successfully completed the first phase of its Advanced Inclusive Research (AIR) Site Alliance programme. The initiative engaged 10 leading government hospitals across the country and trained nearly 400 professionals—including investigators, ethics committee members, and support staff—in global Good Clinical Practice standard.

Drug Discovery & Development | 16/09/2025 | By Darshana |  342

Monte Rosa Therapeutics Partners with Novartis on Degraders for Immune Diseases

Monte Rosa to receive an upfront payment of USD 120 million, plus option maintenance payments, and is eligible for option exercise payments and development, regulatory and sales milestones, as well as tiered royalties on global net sales.

Drug Discovery & Development | 16/09/2025 | By Dineshwori |  394

ANVISA Approves Concept Medical's MagicTouch SCB for CAD in Brazil

The approval enables commercial sales in Brazil, strengthening Concept Medical’s global footprint and advancing its mission to deliver safer and more effective treatment alternatives. The company is also undergoing ANVISA’s approval process for its wider DCB and DES portfolio, building on its robust clinical trial foundation.

Drug Discovery & Development | 16/09/2025 | By Dineshwori |  388

Novartis Enters USD 5.7 Billion Licensing Deal with Monte Rosa Therapeutics Targeting Immune Diseases

Novartis has entered into a licensing agreement with Monte Rosa Therapeutics valued at up to 5.7 billion USD. The deal centres on developing medicines for immune-mediated diseases, where the immune system mistakenly attacks healthy tissue.

Drug Discovery & Development | 15/09/2025 | By Darshana |  359

Fermenta Biotech Secures Indian Patent for Plant-Based Vitamin D3 Invention

Fermenta Biotech has been granted a patent by the Indian Patent Office for its proprietary process to produce plant-based Vitamin D3.

Drug Discovery & Development | 12/09/2025 | By Dineshwori |  611

Merck's Capvaxive Shows Strong Phase 3 Results in Children and Adolescents at High Risk of Pneumococcal Disease

Merck, known as MSD outside the United States and Canada, has reported positive results from its Phase 3 STRIDE-13 trial evaluating Capvaxive, its 21-valent pneumococcal conjugate vaccine.

Drug Discovery & Development | 12/09/2025 | By Darshana |  278

Merck Shuts Down London Drug Discovery Centre, Moves R&D Focus to US

Merck has announced that it will discontinue its drug discovery operations in London, citing an increasingly challenging business environment in the UK. The company has abandoned plans to occupy the Belgrove House site at King’s Cross—which had been scheduled to open in 2027—and will relocate research activities primarily to existing sites in the USA.

Drug Discovery & Development | 12/09/2025 | By Darshana |  293

Alchemab Launches First-in-Human Trial of ATLX-1282, Secures 32 Million USD Financing Boost

Alchemab Therapeutics, a biopharmaceutical company that develops naturally occurring therapeutic antibodies from resilient individuals, has announced the initiation of its first-in-human phase 1 study of ATLX-1282.

Drug Discovery & Development | 10/09/2025 | By Darshana |  440

FDA tightens import controls on obesity drug ingredients amid safety concerns

The Food and Drug Administration (FDA) in the USA has intensified its scrutiny of imports containing GLP-1 drug ingredients, widely used in treatments for weight loss and diabetes, following increasing concerns over safety and quality.

Drug Discovery & Development | 06/09/2025 | By Darshana |  476