EISAI CO

Athira Pharma's lead candidate, fosgonimeton, failed Phase II/III LIFT-AD trial for Alzheimer's, causing a 81% stock drop. Despite missing primary and secondary endpoints, Athira remains committed to fosgonimeton's development, citing potential benefits in specific subgroups. Full data will be presented at the CTAD Conference in Madrid.

The 'Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products Training Course' aims to help participants understand and navigate the complex regulatory landscape for such products in the EU and USA, ensuring compliance and successful commercialization.

The 'Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products Training Course' aims to help participants understand the regulatory frameworks for these products in the EU and USA, offering practical guidance on Notified Body expectations, clinical trial considerations, and post-market surveillance. The course is designed for development and regulatory personnel in the medical device, pharmaceutical, and diagnostic industries.

Multiple biotech companies raise significant funds for various medical advancements, including $600M for Symbiotic Capital targeting biotechnology, medical devices, diagnostics, and synthetic biology; $165M Series A for Third Arc Bio's multifunctional antibodies for oncology and autoimmunity; $144M Series B for Outpace Bio's AI-powered cell therapies for solid tumors; and others ranging from $126M for Halda Therapeutics' RIPTAC cancer therapies to $5M for Kano Therapeutics' targeted, non-viral DNA insertion technology.