Pharma News

Merck & Co. has announced positive topline results from the Phase 3 ATLAS-UC induction-only study evaluating its investigational anti-TL1A monoclonal antibody tulisokibart in patients with moderately to severely active ulcerative colitis (UC).

According to the company, the study successfully achieved both its primary endpoint and key secondary endpoints, marking an important milestone in the development of a potential new treatment option for patients living with the chronic inflammatory bowel disease.

Ministry of Health and Family Welfare has prohibited the manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs) for human use across India with immediate effect.

The decision was taken under Section 26A of the Drugs and Cosmetics Act, 1940, following an extensive scientific review of drug combinations available in the Indian market. The move forms part of the government's ongoing efforts to ensure that only scientifically validated, safe and therapeutically justified medicines remain available to patients.

India's pharmaceutical sector has undergone a significant transformation over the past decade, driven by a combination of affordable healthcare initiatives, domestic manufacturing incentives, and innovation-focused policies. According to the Ministry of Chemicals and Fertilizers, the country has expanded access to low-cost medicines while simultaneously strengthening its position as a global pharmaceutical manufacturing hub.

Alembic Pharmaceuticals Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Binimetinib Tablets, 45 mg. The company had earlier secured tentative approval for the 15 mg strength of the same drug.

The approved generic product is therapeutically equivalent to Mektovi Tablets, 15 mg, marketed by Array BioPharma. Binimetinib is a kinase inhibitor used in combination with encorafenib for the treatment of patients with specific forms of advanced cancer.

Aurobindo Pharma has successfully moved one step closer to completing its strategic acquisition of U.S.-based generic drug manufacturer Lannett Company after the U.S. Federal Trade Commission (FTC) approved the transaction subject to certain divestiture conditions.

The FTC announced that Aurobindo will divest four generic pharmaceutical products to Quagen Pharmaceuticals as part of a consent agreement designed to preserve competition in the U.S. generic medicines market. With this requirement in place, the proposed acquisition of Lannett can move forward toward completion.

GSK has announced an agreement to acquire Nuvalent, a clinical-stage biotechnology company focused on precision cancer therapies, in a transaction valued at approximately 10.6 billion USD. The deal significantly strengthens GSK's oncology pipeline and expands its presence in the rapidly growing lung cancer treatment market.

Biological E. Limited (BE) has achieved a major regulatory milestone with the U.S. Food and Drug Administration (FDA) granting approval for Dalbavancin for Injection, 500 mg per vial (single-dose vial). The product is the generic equivalent of DALVANCE® (dalbavancin) for injection, a widely used antibiotic for treating serious bacterial infections.

AstraZeneca Pharma India has announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for Trastuzumab Deruxtecan (Enhertu) 100 mg/5 mL, allowing its use in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. The approval covers patients whose tumors are classified as HER2-positive through IHC 3+ or ISH+ testing.

In a major advancement in the fight against antibiotic-resistant infections, the U.S. Food and Drug Administration (FDA) has approved Utebzi (tebipenem pivoxil hydrobromide), the first oral carbapenem antibiotic for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. The approval provides patients and healthcare providers with a long-awaited oral alternative to intravenous carbapenem therapy.