Industry News

Astellas Pharma Inc. announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries

Roche announced the entry into a definitive agreement to acquire select parts of the LumiraDx group related to LumiraDx’s innovative Point of Care technology. Following closing of the transaction, which is expected by mid-2024, the acquired entities will be fully integrated into Roche Diagnostics.

AstraZeneca has entered into a definitive agreement to acquire Gracell Biotechnologies Inc, a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases, furthering the AstraZeneca cell therapy ambition.

Bristol Myers Squibb and RayzeBio, Inc. announced a definitive merger agreement under which Bristol Myers Squibb will acquire RayzeBio for USD 62.50 per share in cash, for a total equity value of approximately 4.1 billion USD, or 3.6 billion USD net of estimated cash acquired. The transaction was unanimously approved by both the Bristol Myers Squibb and RayzeBio Boards of Directors.

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.