Generate Biomedicines’ IPO Brings In $400M for Pivotal Tests of Severe Asthma Drug

Flagship Pioneering-founded Generate Biomedicines aims to offer less frequent injections compared to a blockbuster asthma drug from partners Amgen and AstraZeneca. Generate’s drug comes from a “programable biology” platform technology that uses AI and machine learning to design proteins with desirable properties. The post Generate Biomedicines’ IPO Brings In $400M for Pivotal Tests of Severe…

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Regulating Healthcare AI? Look To E-Prescribing

Any regulations applied won’t be as simple as putting on a Band-Aid and forgetting about future problems. To regulate appropriately, we need to learn from the past and act quickly as AI is rapidly incorporated into healthcare.  The post Regulating Healthcare AI? Look To E-Prescribing appeared first on MedCity News.

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FDA Voucher Leads to Speedy Approval of Boehringer Drug for First-Line Use in Lung Cancer

The label expansion for Boehringer Ingelheim’s Hernexeos was made under an FDA pilot program that accelerates regulatory review of products with national interest. The daily pill is now approved as a first-line treatment for HER2-positive non-small lung cancer, an indication with few treatment options. The post FDA Voucher Leads to Speedy Approval of Boehringer Drug…

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