Industry News

The Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic has asked M/s Emcure Pharmaceuticals Limited to revise its proposed Active Post-Marketing Surveillance (PMS) protocol for Liposomal Amphotericin B Injection 50 mg/vial (Lyophilized) before it can be considered further.

The recommendation was made during the 6th SEC (Antimicrobial & Antiparasitic) meeting of 2026, held on June 11, 2026, at the Central Drugs Standard Control Organization (CDSCO) headquarters in New Delhi.

In a significant development in the biosimilar segment, the Subject Expert Committee (SEC) on Dermatology & Allergy has recommended granting permission to M/s Kemwell Biopharma Private Limited to conduct a comparative pharmacokinetic clinical study for its proposed Dupilumab biosimilar, ASP100.

The recommendation was made during the 6th SEC (Dermatology & Allergy) meeting of 2026, held on June 11, 2026, at the CDSCO Headquarters in New Delhi.

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.

Eisai has announced a significant investment in its manufacturing facility in Hatfield, United Kingdom, aimed at expanding its capabilities for medicines that require specialized cold-chain storage and transportation. The project is being supported by the UK Government through the Life Sciences Innovative Manufacturing Fund (LSIMF).

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), as well as the newly approved subcutaneous formulation KEYTRUDA QLEx™, in combination with WELIREG® (belzutifan) for the adjuvant treatment of certain patients with renal cell carcinoma (RCC), the most common form of kidney cancer.

Eli Lilly has announced positive Phase 3 results showing that its BTK inhibitor Jaypirca (pirtobrutinib) significantly improved outcomes for patients with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) when combined with a fixed-duration venetoclax-based regimen. The findings add to growing evidence that targeted combination therapies may help patients achieve longer periods of disease control without continuous treatment.

Lundbeck has unveiled promising early-stage clinical data for its investigational therapy asedebart, highlighting a potential new treatment approach for patients living with Cushing’s disease, a rare endocrine disorder driven by excessive cortisol production. The findings were presented at the ENDO 2026 Annual Meeting in Chicago.