Industry News

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.

Lupin signs an agreement to acquire all rights to two inhalation medicines, Brovana (arformoterol tartrate) Inhalation Solution and Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, from Sunovion Pharmaceuticals Inc. (Sunovion) for a purchase price of around USD 75 million, which is more than 600 crores in Indian rupees.

Inhalation portfolio of Lupin expands in the US with these acquisitions of Brovana and Xopenex HFA.

GSK plc announced that the US Food and Drug Administration has approved a new presentation of Menveo [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate Vaccine] for individuals aged 10 to 55 years to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. The Menveo one-vial presentation now comes in a ready to use single vial giving healthcare providers a more convenient option.

Hetero announced the acquisition of a brownfield manufacturing plant at Penjerla located in Telangana from Johnson & Johnson.

The facility spread across 55.27 acres, will be Hetero’s flagship sterile pharmaceutical and biologics manufacturing unit, bolstered by state-of-the-art technology.

US based Baxter started its global pharmaceuticals research and development (R&D) centre in Ahmedabad, India. This centre will also support Baxter's global manufacturing facilities, including those in Ahmedabad, Germany, Ireland, Italy, and the United States, among others.

GSK plc and Tempus, a US-based precision medicine company, have entered into a three-year collaboration agreement that provides GSK with access to Tempus’ AI-enabled platform, including its library of de-identified patient data. Through its leading Artificial Intelligence and Machine Learning (AI/ML) capability, GSK will work together with Tempus to improve clinical trial design, speed up enrolment and identify drug targets. This will contribute to GSK’s R&D success rate and provide patients with more personalised treatment faster.    

Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Worldwide DMCC has received tentative approval from the United States Food and Drug Administration (USFDA) to market Valbenazine Capsules USP 40 mg, 60 mg, and 80 mg (USRLD: Ingrezza®) & Roflumilast Tablets USP, 250 mcg (USRLD: Daliresp®).