Moderna, Inc. (NASDAQ: MRNA) has announced a significant milestone in its global efforts to combat COVID-19 by securing a contract with Brazil’s Ministry of Health (Ministério da Saúde). The contract entails supplying Moderna’s mRNA COVID-19 vaccine as a crucial component…
Bristol Myers Squibb (NYSE: BMY) and Cellares, the pioneering Integrated Development and Manufacturing Organization (IDMO) dedicated to cell therapy manufacturing, have announced a significant worldwide capacity reservation and supply agreement. Valued at up to $380M in upfront and milestone payments,…
Eli Lilly and Company (NYSE: LLY) and Nexus Pharmaceuticals, LLC have announced a definitive agreement for Lilly to acquire a manufacturing facility from Nexus, a prominent sterile manufacturer in the pharmaceutical sector. This acquisition, located in Pleasant Prairie, Wisconsin and…
Grifols, a global healthcare leader renowned for its plasma-derived medicines, commemorated the 50th anniversary of its Clayton, N.C. flagship facility today. Since its inception, this site has been pivotal in delivering life-saving therapies to countless patients worldwide. Originally established as…
Shionogi & Co., Ltd. unveiled groundbreaking findings from the largest European real-world evidence study, PERSEUS, at the 34th ESCMID Global (formerly ECCMID) conference in Barcelona from April 27th to 30th, 2024. The study focused on Fetroja®/Fetcroja® (cefiderocol), a novel siderophore…
GSK plc (LSE/NYSE: GSK) has unveiled encouraging outcomes from the pivotal EAGLE-1 phase III trial concerning gepotidacin, a prospective first-in-class oral antibiotic offering a novel approach to combat uncomplicated urogenital gonorrhoea (GC) in adolescents and adults. These findings are slated…
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) has unveiled significant progress in its suzetrigine pain program, potentially introducing the first new class of medication for acute and neuropathic pain in over twenty years. Suzetrigine, an oral selective NaV1.8 pain signal inhibitor (previously…
Novartis has revealed findings from the ALITHIOS open-label extension study, demonstrating the sustained efficacy of continuous Kesimpta® (ofatumumab) treatment for up to six years in individuals recently diagnosed with relapsing multiple sclerosis (RMS). These individuals, termed “treatment-naïve,” initiated treatment within…
Roche Receives FDA Approval for Alecensa as Adjuvant Therapy in ALK-Positive Early-Stage Lung Cancer Roche has announced that the U.S. Food and Drug Administration (FDA) has granted approval for Alecensa® (alectinib) as adjuvant therapy following tumor resection in patients with…
Today, the joint effort of the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) culminated in the publication of a comprehensive report detailing the outcomes of their recent workshop on COVID-19 vaccine strain updates. Conducted…
UCB’s FINTEPLA®▼ (fenfluramine) oral solution has received approval from the Japanese Ministry of Health, Labour, and Welfare (MHLW) for treating seizures linked with Lennox-Gastaut syndrome (LGS) as an additional therapy alongside other anti-epileptic medications for patients aged two and above.…
Alert Overview This alert from the World Health Organization (WHO) addresses the discovery of falsified DOW USP/EP Propylene Glycol in Pakistan. Authentic DOW USP/EP Propylene Glycol is a crucial raw material used in pharmaceutical and other manufacturing processes, meeting the…