Ipsen

It marks the awaited green light for Ipsen following its acquisition of Onivyde in 2017. The FDA has given its nod to the supplemental new drug application for Onivyde (irinotecan liposome injection) in combination with oxaliplatin, fluorouracil, and leucovorin (NALIRIFOX) as a primary treatment for adults with met...

Merck and Moderna Initiate INTerpath-002, a Phase III Study Evaluating V940 in Combination with KEYTRUDA for Adjuvant Treatment of Patients with Certain Types of Resected NSCLC Merck (also known as MSD outside the United States and Canada) and Moderna, Inc. have commenced the INTerpath-002 trial—a crucial Phase ...

GSK Announces Extension of FDA Review Period for Momelotinib After all, GSK will not hear from the FDA this month about its marketing application for momelotinib as a therapy for anemia in myelofibrosis patients. The pharmaceutical company announced that the US Food and Drug Administration has extended the drug'...

FDA Grants Orphan Drug Designation to Osemitamab for Pancreatic Cancer Transcenta Holding Limited has announced that the U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation to Osemitamab (TST001), a highly potent humanized monoclonal antibody that enhances ADCC (antibody-dependent cell-me...

Ipsen to Acquire Albireo for USD 952 Million Ipsen, a French pharmaceutical company, has offered USD 42 per share for the US biotech Albireo and its rare disease treatment Bylvay, continuing a recent spree of merger and acquisition activity. Albireo, a Boston-based business, is valued at USD 952 million under th...

EicOsis has received USD 15Million grant from the National Institute of Drug Abuse (NIDA) to fund the clinical trials of non-opioid pain therapy. NIDA, with an aim to supplement NIH’s initiative Helping to End Addiction Long-Term (HEAL Initiative), has awarded the grant to the company. Deaths due to drug ov...

Aurobindo takes top generic spot in Portugal with €135M deal for Generis Farmacêutica India’s Aurobindo Pharma, which has been building its presence around the world, has struck a new deal to buy a generics manufacturer and plant in Portugal which it says will make it the largest generics manufacturer in that countr...