Industry News

Takeda announced that LIVTENCITY (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. LIVTENCITY is the first and only inhibitor of CMV-specific UL97 protein kinase in China for this indication.

Intas Pharmaceuticals Ltd., a leading multinational pharmaceutical company, has announced today a strategic exclusive licensing agreement with mAbxience (a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma) for a biosimilar for Etanercept. Etanercept is a dimeric fusion protein with tumor necrosis factor (TNF) blocking action that was approved for use over 20 years ago, offering patients a valuable therapeutic option for treating various autoimmune diseases.

The U.S. Food and Drug Administration approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD). As part of a clinical evaluation, the AutoGenomics, Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure.

JB Chemicals & Pharmaceuticals Ltd. (JB Pharma) agreed to acquire the ophthalmology portfolio of Novartis for INR 964 Crore. It will include INR 125 Crores (excluding applicable taxes, stamp duty and working capital) under the Promotion and Distribution Agreement to Novartis Healthcare Private Limited, India.

Torrent Pharma has announced that the United States Food and Drug Administration (USFDA) has conducted the inspection with 5 procedural observations at the Company's Oral-Oncology manufacturing facility situated in Bileshwarpura, Gujarat.

AstraZeneca to acquire Icosavax, including potential first-in-class RSV and hMPV combination vaccine with positive Phase II data

AstraZeneca has entered into a definitive agreement to acquire Icosavax, Inc , a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform.

The U.S. Food and Drug Administration approved two milestone treatments, Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease (SCD) in patients 12 years and older. Additionally, one of these therapies, Casgevy, is the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy.

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.

Novartis announced that the U.S. Food and Drug Administration (FDA) approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH]).