Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
GSK bets $500M on Hengrui pipeline in licensing pact
In a move that underlines big pharma’s growing interest in early-stage Chinese innovation, GSK has struck a $500 million licensing deal with Jiangsu Hengrui Pharmaceuticals (Hengrui) for up to 12 drug programs spanning oncology, respiratory, immunology, and inflammation. As Western pharma companies face mounting pipeline pressure, this deal highlights a shift toward sourcing high-potential assets from emerging R&D engines abroad. For Hengrui, the collaboration offers validation and funding while allowing it to remain focused on discovery. For GSK, it’s a bet on complementing its portfolio with programs selected for their potential best- or first-in-class profiles, an increasingly common strategy to secure future growth beyond 2031. – Andrea Corona
Vinay Prasad leaves post as top official at FDA
After less than three months, Vinay Prasad resigned from his position as the Director of the FDA’s Center for Biologics Evaluation and Research. His resignation followed strong critiques from right-wing influencer Laura Loomer on social media, who pointed to Prasad’s prior support of Senator Bernie Sanders. Prasad’s decision to leave also came shortly after the FDA reversed their decision to halt shipments of Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, a product that Prasad had been critical of when the FDA initially approved it back in 2023. “Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family,” said a spokesperson for the US Department of Health and Human Services in a statement to various news sources. – Allison Whitten
Alzheimer’s antibody clears 91 percent of brain plaques in just seven months
Roche’s anti-amyloid antibody trontinemab cleared brain plaques in 91 percent of patients at the highest dose in a Phase 1b/2a trial, with 72 percent achieving “deep clearance” after just seven months. This is particularly relevant for early-stage patients, where removing plaques can help slow cognitive decline. Presented at Alzheimer's Association International Conference (AAIC) 2025, the results spotlight Roche’s Brainshuttle platform, which uses a transferrin receptor-mediated transport system to actively ferry antibodies across the blood-brain barrier, a major challenge in neurotherapeutics. By enhancing brain penetration, Brainshuttle may enable lower doses, faster plaque reduction, and potentially broader applications in neurodegenerative disease. Safety signals were also reportedly low, with only four cases of amyloid-related imaging abnormalities (ARIAs) among 149 patients. However, one trial participant, a 78-year-old woman, died of a brain hemorrhage linked to a known ARIA risk factor. The company now plans to launch two Phase 3 trials in 2025 to test trontinemab in patients at risk of cognitive decline. “Alzheimer’s disease represents one of the greatest challenges in healthcare today and tackling it requires early detection and effective therapeutics,” said Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche, in the press release. – Bree Foster
FDA invites CEOs to help shape future drug regulation
The FDA has launched a national listening tour to engage directly with biotech and pharma executives through a series of CEO Forums held in key innovation hubs, aiming to gather input on how to modernize its regulatory framework to better support innovation and patient access. Led by FDA Commissioner Marty Makary alongside senior leadership from the drug and biologics centers, the forums are open to companies with an active IND, NDA, or BLA on file. While CEO participation is preferred, senior scientific leaders may also attend, and registration is limited to one forum per company. For drug developers, this is more than a listening session, it’s a rare opportunity to push for faster reviews, clearer guidance, and smarter oversight directly with top FDA decision-makers. It’s also a moment to spotlight real-world regulatory pain points and help shape a framework that keeps pace with modern science. Upcoming stops include New York City, Raleigh, and Atlanta, though space is limited and final eligibility is determined by the agency. – Andrea Corona
Artbio raises $132M for radiopharmaceuticals
Artbio, a startup led by Emanuele Ostuni formerly of Novartis, announced that they have raised $132 million in series B funding to continue developing a novel class of radioligand therapies. The funding will also support their lead asset targeting prostate cancer, AB0001, into Phase 2 trials. This round of funding included new investments from Sofinnova Investments and B Capital. Robert Mittendorff, General Partner at B Capital said in a press release, "ARTBIO's lead asset, AB001, is designed to fully harness the unique power of lead-212. My team and I are excited for what's to come.” – Allison Whitten
Celcuity’s breast cancer drug dramatically reduces the risk of progression or death
Shares in Celcuity soared by 190 percent after its experimental breast cancer drug, gedatolisib, significantly delayed disease progression in a Phase 3 trial. The study tested gedatolisib alongside standard treatments in women with advanced HR-positive, HER2-negative breast cancer that had stopped responding to earlier therapy. When combined with fulvestrant and palbociclib, gedatolisib reduced the risk of cancer progression or death by 76 percent compared to fulvestrant alone. This extended median progression-free survival from two months to over nine months, a result that Celcuity’s Chief Medical Officer called “potentially paradigm shifting.” Even when used without palbociclib, the drug showed strong benefits, cutting the risk by 67 percent and extending progression-free survival to 7.4 months. Full results will be presented later this year, and the company plans to file for FDA approval soon. – Bree Foster
