CHMP recommends EU approval of Roche’s fixed-duration Columvi for large B-cell lymphoma

Once approved, Columvi will be the first CD20xCD3 T-cell-engaging bispecific antibody available to treat people in Europe with this aggressive lymphoma

Briefs: Lupin and Alembic

Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.

Glenmark and Cediprof inks exclusive distribution agreement in US

The agreement is for USFDA approved Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients

Biocon Q3 FY23 revenue up 36%

The company's consolidated revenues for the quarter grew 36% to Rs. 3,020 crore on the back of robust performance across all its three businesses

Lupin receives approval from USFDA for Prasugrel Tablets, USP

Lynparza in combination with Abiraterone and Prednisone approved in the EU as treatment for metastatic castration-resistant prostate cancer

First PARP inhibitor and new hormonal agent combination approved for these patients in Europe

Glenmark receives ANDA approval for Sodium Phenylbutyrate Tablets

Glenmark’s Sodium Phenylbutyrate Tablets USP, 500 mg, will be distributed in the U.S. by Glenmark Pharmaceuticals USA.

USFDA Issues a CRL for the Biologics License Application for Insulin Aspart

The CRL did not identify any outstanding scientific issues with the product.

Merck’s PREVYMIS effective for prevention of cytomegalovirus disease in adults post kidney transplantation

Separate Phase 3 study evaluating 200 days of therapy with PREVYMIS in HSCT recipients at high risk of late clinically significant CMV infection recently completed, meeting its primary endpoint