News and Trends 4 May 2023 World’s first RSV vaccine for older adults gets FDA approval GSK plc says the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. It is the first RSV vaccine for older adults to be approved anywhere in […] May 4, 2023 - 5 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 May 2023 Positive study results: Lilly’s Alzheimer’s drug slows patients’ decline Eli Lilly and Company has announced positive results of the TRAILBLAZER-ALZ 2 phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease. Donanemab met the primary endpoint of change from baseline until 18 months on the integrated Alzheimer’s Disease Rating Scale (iADRS). The primary endpoint of […] May 3, 2023 - 8 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 May 2023 Eterna acquires allogeneic immuno-oncology platform from Exacis Eterna Therapeutics Inc. has announced the acquisition of the global immuno-oncology platform of Exacis Biotherapeutics. The acquisition complements Eterna Therapeutics’ core business with a pipeline of allogeneic immuno-oncology products under development for the treatment of hematologic and solid tumors and provides Eterna Therapeutics with an exclusive global license to produce an unlimited number of mRNA-engineered […] May 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 3 May 2023 First drug discovered through 3D bioprinted tissue disease model Viscient Bio, Inc. has announced it has identified the world’s first drug candidate discovered primarily using 3D bioprinted tissue models of disease formed from human cells. The company said it expects to develop the drug to treat non-alcoholic steatohepatitis (NASH), a growing epidemic disease that is believed to affect more than 10% of the U.S. […] May 3, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 2 May 2023 Cabaletta Bio’s lupus drug cleared for trial Cabaletta Bio, Inc., a U.S. clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation to CABA-201. Cabaletta Bio’s CABA-201 is a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, designed […] May 2, 2023 - 3 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 2 May 2023 FDA fast track for Memo’s kidney transplant infection treatment Memo Therapeutics AG, a biotech company developing therapeutic antibodies, says the U.S. Food and Drug Administration (FDA) has granted fast track designation to AntiBKV, Memo Therapeutics’ lead antibody therapeutic that targets BK polyomavirus (BKV) infection commonly seen in renal transplant patients. AntiBKV has successfully completed a phase I clinical study and following FDA clearance has […] May 2, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 2 May 2023 Astellas eyes ophthalmology field with $5.9B Iveric Bio takeover Astellas Pharma Inc., through Berry Merger Sub, Inc., a wholly-owned subsidiary of Astellas US Holding, Inc., has agreed to acquire 100% of the outstanding shares of Iveric Bio, Inc., for $40 per share in cash for a total equity value of approximately U.S. $5.9 billion. Iveric Bio will become an indirectly wholly-owned subsidiary of Astellas. […] May 2, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 2 May 2023 Schizophrenia injection gets FDA approval Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell have announced the U.S. Food and Drug Administration (FDA) has approved UZEDY (risperidone) extended-release injectable suspension for the treatment of schizophrenia in adults. UZEDY is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq, a copolymer technology proprietary to MedinCell that controls […] May 2, 2023 - 4 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 2 May 2023 Single-molecule valve breakthrough could lead to early disease diagnosis Molecules are incredibly small – around one hundred millionth the size of a softball – and they move randomly in liquids, making it difficult to manipulate them in a single form. To overcome this challenge, “nanofluidic devices” that can transport molecules in extremely narrow channels, similar in size to one millionth of a straw, are […] May 2, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 28 Apr 2023 Brenus Pharma reveals ‘groundbreaking’ preclinical results for colorectal cancer and solid tumor drug Brenus Pharma has announced what it said are two groundbreaking presentations on STC-1010, the company’s first drug candidate for colorectal cancer (CRC), produced by Brenus Pharma’s STC (stimulated tumor-cells) technology platform. Innovative models for anti-tumor vaccine development were highlighted: Inovotion’s CAM (chorioallantoic model) in-ovo assay and Explicyte’s ex-vivo co-cultured assay, were used to characterize the […] April 28, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 28 Apr 2023 Mezzion Pharma raises $40M for treatment option for heart surgery patients Mezzion Pharma, a rare disease focused pharmaceutical company, has secured nearly $40 million to fund FUEL-2, its confirmatory phase 3 clinical trial, along with future commercialization and regulatory submissions in other countries including Europe. Mezzion Pharma is looking to bring to market JURVIGO (udenafil), a highly selective, unique and potent phosphodiesterase type 5 (PDE-5) inhibitor, […] April 28, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email
News and Trends 28 Apr 2023 Vitalli Bio formed to focus on immunological disorders Aditum Bio has announced the formation of Vitalli Bio, a portfolio company created for the development of novel therapies for immunological disorders. Aditum Bio is a biotech investment firm cofounded in 2019 by former Novartis CEO Joe Jimenez and former president of the Novartis Institutes for BioMedical Research (NIBR) Mark Fishman. Vitalli Bio is being […] April 28, 2023 - 2 minutesmins - By Jim Cornall Share WhatsApp Twitter Linkedin Email