Industry News

Moderna's motion to dismiss a patent infringement suit focused on COVID-19 vaccine technology was dismissed after the company argued that the case should be against the U.S. government rather than itself.

Lupin Limited has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Drospirenone Tablets, 4 mg, to market a generic equivalent of Slynd Tablets, 4 mg, of Exeltis USA Inc.

Drospirenone is a progestin medication which is used as contraceptive to prevent pregnancy and in menopausal hormone therapy, among other uses.

New study published in Journal Vaccine suggests that the Biological E COVID-19 vaccine, Corbevax, is highly immunogenic and can be safely administered to the pediatric population as young as 5 years old.

After establishing safety and immunogenicity of Biological-Es CORBEVAX vaccine in the adult population (18–80 years) in Phase 1–3 studies, the vaccine is further tested in children and adolescents in this study.

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ketorolac Tromethamine Injection USP, 15 mg/mL, 30 mg/mL, and 60 mg/2 mL (30 mg/mL) Single Dose Vials.

This is the second injectable product approval from our General Sterile Facility (F-3) which was inspected in August, 2022.

Alembic Pharmaceuticals Limited (Alembic) announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Mesalamine Extended-Release Capsules USP, 0.375 g.

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Apriso Extended-Release Capsules, 0.375 g, of Salix Pharmaceuticals, Inc. (Salix).

Sun Pharma records growth of 13.1 percent over Q2 last year.  The gross sales reached at Rs. 108,092 million. In this quarter, the company launched 34 new products in the Indian market.

Sun Pharma market share has increased by 0.5 pc to 8.6 pc over the last one year, as per AIOCD AWACS MAT Sept-2022 report. As per SMSRC MAT August-2022 report, Sun Pharma is topped in prescriptions with 12 different doctor categories.

Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce it has launched their Fingolimod Capsules, 0.5 mg, the generic version of Gilenya®1 Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation.

Commenting on the launch, Sanjeev Krishan, President, Glenmark North America said, “We are very pleased to bring to market a lower cost alternative to Gilenya® Capsules, 0.5 mg. This launch confirms our commitment to provide quality and affordable pharmaceutical products to patients.”

Novavax, Inc a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has received emergency use authorization (EUA) from the U.S.

Lupin Biotech manufacturing facility in Pune receives 17 observations after prior approval inspection by US FDA.

The Company does not believe that the 483 letter will have an impact on the existing revenues from operations of this facility.

The U.S. FDA conducted a Prior-Approval Inspection at Lupin’s Biotech manufacturing facility in Pune, India in October 2022. The inspection concluded with the issuance of a Form 483 with seventeen observations.