Aurobindo Pharma has announced positive results from a Phase 3 clinical trial of its breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by its subsidiary, Curateq Biologics. The clinical trial demonstrated that BP02 has a comparable efficacy and safety profile to Herceptin. The trial was a multi-center, randomized, double-blind study involving women […]
Aurobindo Pharma, along with its subsidiary Eugia Pharma Specialities has announced a voluntary sub-licensing agreement with Medicines Patent Pool (MPP) to develop and market Nilotinib Capsules. Originally developed by Novartis, Nilotinib Capsules are used for the treatment of chronic myeloid leukemia (CML) in 44 low and middle-income countries (LMIC). This agreement covers seven countries where […]
Aurobindo Pharma said that its fully-owned subsidiary — Eugia Pharma Specialities has secured final approval for Amphotericin B Liposome for Injection, 50 mg from the US Food & Drug Administration (FDA). The approved product is bioequivalent and therapeutically equivalent to Astellas Pharma US’ AmBisome Liposome for Injection, 50 mg/vial. Amphotericin B Liposome for Injection is […]
Aurobindo Pharma has been issued an establishment inspection report (EIR) from the US Food and Drug Administration (FDA) for one of its manufacturing facilities in Telangana, India. The Indian pharma company said that the FDA completed an inspection at its Unit VII, an oral manufacturing facility in Jadcherla town and issued the EIR. The report […]
Aurobindo Pharma has secured consent from the Drugs Controller General of India (DCGI) for manufacturing and distributing its generic version of Covid drug Molnupiravir under the brand name — Molnaflu. The Indian pharma company had previously acquired the licensing rights for the generic version of MSD and Ridgeback Biotherapeutics’ Molnupiravir. A non-exclusive voluntary licensing agreement […]
Aurobindo Pharma said that its subsidiary Eugia Pharma Specialities has secured approval from the US Food and Drug Administration (FDA) for the new drug application for its Cyclophosphamide Injection 500 mg/2.5 mL and 1 g/5 mL vials. Cyclophosphamide Injection is indicated in the US for malignant lymphomas, multiple myeloma, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, […]
Aurobindo Pharma Limited has scrapped its previously signed binding agreements with Cronus Pharma Specialities India Private Limited, under which it was to acquire a stake of 51% in the latter for INR 420 crores. The Hyderabad-based pharma manufacturing company said that its board of directors in its meeting held has approved the termination of the […]
In a major strategic move, Spectrum Pharmaceuticals, a prominent US-based biopharma company, has entered into a deal with Acrotech Biopharma, a subsidiary of Aurobindo Pharma USA, to sell seven FDA-approved oncology and hematology drugs for approximately $300 million. The decision is part of Spectrum’s broader strategy to pivot towards innovative cancer therapies, according to the […]
Aurobindo Pharma, a prominent Indian pharmaceutical company, has agreed to a significant acquisition from Sandoz US, a division of the Swiss pharmaceutical giant Novartis. The deal, valued at approximately $1 billion, involves the purchase of Sandoz’s dermatology business and a diverse portfolio of oral solid products, along with commercial and manufacturing infrastructure. The transaction terms […]
In a strategic move within the pharmaceutical industry, Sandoz US, a subsidiary of the Swiss-based Novartis, has announced the sale of its dermatology and oral solids businesses to Aurobindo Pharma, an Indian pharmaceutical giant. The deal, which includes a $900 million cash payment and potential earn-outs of $100 million, marks a significant reshaping of Sandoz’s […]