BioSpace

💻 Now available to view on demand! The FDA’s draft guidance on the validation of non-animal methods (NAMs) is reshaping how nonclinical programs are designed and justified. This webinar, in partnership with Certara, explores how sponsors can apply NAMs to streamline development, improve human relevance, and support IND decision-making within a weight-of-evidence framework. https://hubs.li/Q04nfYPm0

Ipsen is penning its second acquisition of the week, this time securing Memo Therapeutics AG and its midstage monoclonal antibody in a deal that could approach $800 million. https://hubs.li/Q04nj8x50

The approval of Tregzi—the first regulatory greenlight for Orca Bio—was based on a Phase 3 study in which patients on the therapy were twice as likely to survive without cancer relapse and without chronic GVHD compared with conventional allogeneic transplant. https://hubs.li/Q04njhYl0

Innovation drives CROs to win new business, but unchecked customization creates complexity that undermines reproducibility, weakens renewals and leads to turnover—making standardization a strategic necessity, not a constraint. https://hubs.li/Q04ndBvN0

The 2022 search approach is no longer working. Companies need to think critically about how they are acquiring top regulatory, clinical and commercial executives or risk their programs in this new regulatory and market reality, writes Emma Morris. https://hubs.li/Q04ndscl0

The total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back. https://hubs.li/Q04ndBhw0

Teams at facilities being developed by Eli Lilly and Company, Regeneron and other companies will receive early technical guidance and additional perks from the FDA. https://hubs.li/Q04nc_XR0

The U.K.’s core biotech cluster continues to produce world‑class science, but investors say limited talent mobility, uneven regional growth and tightening early‑ and mid‑stage capital are slowing the country’s ability to scale new companies. https://hubs.li/Q04ndxyd0

🎙️ New on The Weekly! The vibe at BIO 2026 in San Diego last week was overwhelmingly positive, with attendees observing noticeable changes at the FDA and an uptick in dealmaking and IPOs. Plus, a top medical journal this week retracted a pivotal study for Amgen’s rare disease drug Tavneos, which has been in the FDA’s crosshairs since January. https://hubs.li/Q04ndB0v0

Sarepta Therapeutics is seeking to convert the accelerated approval of its therapeutic exon-skippers for Duchenne muscular dystrophy to full despite the drugs’ failure to improve motor function in a confirmatory trial. https://hubs.li/Q04ndryT0