| .png) | Product to Patient Partner with ICON to accelerate the development of your devices and diagnostics that save lives and improve quality of life. Learn More. |
Featured Story | By Amirah Al Idrus Exactly six months after granting Iterum’s oral antibiotic a speedy review, the FDA rejected the application saying more data is needed from at least one additional trial. Iterum received a complete response letter from the agency on Friday declining to approve the drug, the company revealed on Monday. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor AbbVie has shared full results from a phase 3 trial it is hoping will persuade the FDA to approve a medicine solution for far-sightedness, which is typically treated with contacts or glasses. The study of AGN-190584 showed significant improvements in the vision of patients with age-related far-sightedness after 30 days of dosing. read more By Annalee Armstrong Investors tracking Denali Therapeutics’ Hunter syndrome therapy were left unimpressed after results from an exploratory endpoint showed ongoing brain cell death even with treatment. Shares of the South San Francisco, California-based biotech dropped 13% to $55.34 as the markets opened Monday. read more Sponsored By: Clever Leaves Medical cannabis from Colombia can change lives. read more By Ben Adams Incyte snuck out some bad news Friday night: Afterhours, the Wilmington, Delaware-based biopharma said it had been hit with an FDA complete response letter for its experimental checkpoint inhibitor retifanlimab. read more By Ben Adams Canadian life sciences fund Lumira Ventures has raised a major tranche of cash as it looks to funnel an extra $220 million into the sector. read more By Nick Paul Taylor Bayer has appointed Dominik Ruettinger as its head of research and early development for oncology. Ruettinger is set to join the German conglomerate from Roche, following in the footsteps of Bayer’s head of R&D Christian Rommel. read more By Amirah Al Idrus Proteins that switch genes on and off are some of the most important drug targets—and also some of the oldest, according to Alex Federation, Ph.D., co-founder and CEO of Talus Bio. But most of them are tricky to drug. Talus Bio is using a new approach to go after these targets systematically and create drugs that knock these proteins off of DNA and switch off disease-causing proteins. read more By Kyle LaHucik Bayer-owned subsidiary BlueRock Therapeutics is promoting Chief Scientific Officer Seth Ettenberg, Ph.D., to president and CEO, as Emile Nuwaysir, Ph.D., will transition to board chair on August 1. read more By Fraiser Kansteiner Cell and gene therapies are already revolutionizing treatment for some diseases, but scores more are working their way toward market—and they all have to make it through the tricky step of scaling up manufacturing. Some players are reimagining how it's done. read more By Conor Hale PerkinElmer aims to cement itself as a major provider of reagents and consumables for precision medicine and diagnostic test development through a $5.25 billion deal for BioLegend, a global producer of antibodies and other research tools. read more By Dave Muoio AHA, AEH and AAMC join more than 50 other professional groups backing mandatory COVID-19 vaccination policies as nationwide hospitalization rates tick upward. No small number of hospitals and health systems have already chosen to implement the requirements for a collective hundreds of thousands of healthcare staff. read more Resources Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Evidera, a PDD business Learn about key post-marketing safety study solutions, including registries and REMS, and how they can most effectively help meet regulatory requirements and maximize patient access. Sponsored by: WCG Engage Independent Expert Endpoint Adjudication and Data Monitoring Committees in a strategic manner to identify methods for retrospective and prospective evaluations that may improve competitive advantage and bolster regulatory submissions. Sponsored by: Patheon by Thermo Fisher Scientific Take a closer look at your supply chain to ensure it delivers with speed, efficiency, and quality — all within budget. Sponsored by: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: Blue Matter Consulting E-book to get newcomers “up to speed” quickly on digital health and digital therapeutics while also addressing key issues important to those already familiar with the topic. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. | 
