– Company has received a No Objection Letter from Health Canada in response to submission of its Phase 1 Clinical Trial Application (CTA) – The study is a Phase 1 Single Ascending Dose (SAD) /Multiple Ascending Dose (MAD) and food effects (FE) and includes multiple dose treatment of UC patients; Global UC market is expected to grow to nearly $10 Billion by 2028 Oct. 10, 2024 -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio” or the “Company”), a biopharmaceutical company focused o

Investigational agent in development as a one dose treatment or prevention of seasonal and pandemic influenza A dose ranging, Phase 1 study in healthy volunteers demonstrated positive tolerability results and plasma levels in the predicted therapeutic window, enabling selection of Phase 2 dose Preclinical data showed potent inhibition of drug-resistant and bird influenza viruses Phase 2 study expected to begin in H1 2025 Improved therapy is an important need for both seasonal and pandemic flu Oc

AI (Artificial Intelligence) and ML (Machine Learning) drug discovery collaboration will accelerate the development of small molecules as orally available host-targeted broad-spectrum medical countermeasures Host-directed antiviral drugs have the potential to enhance the immune response to viruses from a range of viral families Tonix was awarded a contract with the U.S. Department of Defense for up to $34 million for the accelerated development of its host-directed broad-spectrum antiviral progr

Safety, pharmacokinetics and target engagement data from first-in-human Phase 1 clinical trial in healthy volunteers will potentially enable rapid advancement of IMSB301 into Phase 1b/2 clinical studies in Type I interferonopathies Oct. 08, 2024 -- ImmuneSensor Therapeutics, a clinical-stage biotherapeutics company focused on the development of first- and best-in-class inhibitors and agonists targeting the cGAS-STING pathway to address diverse peripheral and CNS indications in inflammation,

Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for dasiglucagon in CHI for up to three weeks of dosing due to the timing of a third-party manufacturing facility reinspection The reinspection of the facility was completed in August/September 2024 for which a new inspection classification is pending Zealand remains committed to working with the FDA and the third-party manufac

Oct. 08, 2024 -- Oragenics Inc. (NYSE American: OGEN), a company focused on developing new treatments for brain-related health conditions, has completed a key study for their new concussion drug, ONP-002. This drug is designed to be delivered through the nose, which could help it reach the brain quickly after a head injury. The recent study shows that the drug successfully targets areas inside the nose that are connected to the brain. This makes it more likely to reach and treat the brain afte

Oct. 08, 2024 -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced a regulatory update from the U.S. Food and Drug Administration (FDA). The FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment

Rapid epinephrine absorption with a time to reach the 100 pg/mL threshold concentration in 9 minutes after dosing Sustained pharmacokinetics (PK) with plasma epinephrine concentration remaining above 100 pg/mL for 2 hours post-dose, ensuring a durable treatment effect Safe and well tolerated, with only mild, transient, and self-resolving adverse events (AEs) reported Oct. 07, 2024 -- Insignis Therapeutics, a leader in innovative allergy and anaphylaxis treatments, is excited to announce positiv

Prolia® (denosumab) is indicated to treat certain conditions that lead to high risk for fracture, including osteoporosis in postmenopausal women TVB-009P, Teva’s proposed biosimilar to Prolia, showed Phase 3 clinical results in osteoporosis and is part of Teva’s robust biosimilar portfolio – 7 approved biosimilars and 16 in the pipeline – across critical therapeutic areas such as oncology, immunology and respiratory medicine Anticipated decision by both agencies is expected in 2H 2025 Oct. 08,

Oct. 08, 2024 -- E-Star BioTech, LLC (“E-Star” or the “Company”), an innovative developer of novel peptides designed to treat cardiovascular, metabolic, and kidney diseases, today announced that it is set to initiate a Phase 2 clinical trial of MANP for the treatment of Resistant Hypertension (BOLD-HTN) supported by a recent round of financing. MANP was originally discovered by John C. Burnett Jr., MD, Director of the Cardiorenal Research Laboratory at Mayo Clinic. E-Star and Mayo Clinic enter