Industry News

Biosergen AB (Biosergen) and Alkem Laboratories Ltd. (Alkem) are pleased to announce the signing of a co-development and license agreement for BSG005, an innovative polyene macrolide, through phase II and phase III trials for sale in the Indian market. 

GSK plc announced that the US Food and Drug Administration (FDA) has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia), in adults with anaemia. Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor.

Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Relievant Medsystems, Inc., a privately held medical technology company that has developed and commercialized the Intracept Intraosseous Nerve Ablation System to treat vertebrogenic pain, a form of chronic low back pain. The transaction includes an upfront cash payment of 850 million USD and undisclosed additional contingent payments based on sales performance over the next three years.

Strides Pharma Science Limited announced that its step‐ down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for its New Drug Application (NDA) 505b2 of Dolutegravir/ Lamivudine/ Tenofovir Disproxil Fumurate 50mg/ 300mg/ 300mg tablets from the United States Food & Drug Administration (USFDA). The Product will be manufactured at the company’s facility in Bengaluru.

Cipla South Africa, a 100% owned subsidiary of Cipla Limited signed a binding term sheet with Actor Holdings (Pty) Limited to acquire 100% of the issued ordinary shares of Actor Pharma (Pty) Limited. This development underpins Ciplas commitment and investment in its over the counter (OTC) business and supports its journey to be a leading healthcare player in South Africa. This is a strategic acquisition for Cipla South Africa to unlock the future growth opportunities and leverage cost synergies in the South African market.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) for Isotretinoin Capsules USP, 10 mg, 20 mg 30 mg and 40 mg (RLD: Accutane® Capsules, 10 mg, 20 mg and 40 mg: RS: Claravis 10 mg, 20 mg, 30 mg and 40 mg).

Sandoz, a global leader in generic and biosimilar medicines, has successfully completed the acquisition of worldwide brand rights for leading systemic antifungal agent Mycamine (micafungin sodium, Funguard in Japan) from Astellas.

Through this acquisition of the leading global echinocandin, one of three major antifungal classes, Sandoz significantly reinforces its global hospital offering and leading anti-infectives portfolio.

Soliris (eculizumab) has been approved in Japan for expanded use to include the treatment of generalised myasthenia gravis (gMG) in paediatric patients who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX). Soliris is the first and only targeted therapy approved for the treatment of children and adolescents with gMG in Japan.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.