| 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. | From speedy review to standstill: FDA spurns Iterum’s antibiotic, demands another trial Abbvie posts new data on drug that could replace glasses or contacts for far-sightedness Denali’s Hunter syndrome data fails to impress, but ‘Aduhelm-lenient’ FDA could still approve Sponsored: Medical Cannabis from Colombia Can Change Lives FDA deals blow to Incyte's PD-1 retifanlimab after battering advisory panel meeting Lumira Ventures raises largest investment pot to date, nabbing $220M for life sciences bets Bayer poaches Ruettinger from Roche to head up early cancer R&D To turn off disease-causing genes, Talus Bio wants to knock proteins off of DNA Bayer's BlueRock Therapeutics adjusts leadership team with CSO promoted to CEO Robots, automation and pod factories: How cell and gene therapy makers are catching production up to speed PerkinElmer inks massive $5.25B deal for reagent producer BioLegend More than 50 medical groups push healthcare employers to require COVID-19 vaccination 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 |
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| 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. 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