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24 March, 2026 |
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sponsored by
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Built for Speed: Integrated Early‑to‑Late Phase CDMO Solutions
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| Avid Bioservices delivers solution‑focused capabilities and the capacity biopharma innovators need to advance programs with confidence. Our new Early Phase Center of Excellence, centrally located in Costa Mesa, California, provides rapid, flexible support for early development with a direct, seamless transition into our late‑stage and commercial manufacturing facility. This integrated approach reduces handoffs, accelerates timelines, and helps keep your therapy moving efficiently toward patients. |
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Today, a group of biotech investors was scheduled to meet with a congressional panel charged with keeping the US competitive in the industry. According to the agenda, the group was slated to discuss FDA uncertainty and the impact of President Donald Trump’s drug pricing policies. Max Bayer has the scoop. |
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Alexis Kramer |
Editor, Endpoints News
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by Zachary Brennan
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The FDA warned California-based ImmunityBio for a TV advertisement and podcast that gave the "misleading impression" that Anktiva, the company's treatment for a type of bladder cancer, can cure or prevent all cancers. The ad and podcast featured billionaire entrepreneur and ImmunityBio founder Patrick Soon-Shiong. He
falsely claimed that Anktiva is "intended for new uses for which it lacks approval," the FDA said in the warning letter released on Tuesday. The March 13 letter is a sign that the FDA, which has become more political with
appointees serving as center directors, is not afraid to push back against allies of HHS Secretary Robert F. Kennedy Jr. like Soon-Shiong. The agency noted that it's especially concerned with the ad and podcast because it sent two prior letters in September 2025 and January 2026 to ImmunityBio's subsidiary Altor BioScience over similar misrepresentations of Anktiva. | |
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by Ayisha Sharma
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Gilead Sciences is set to enter the T cell engager space in an unusual — perhaps even unprecedented — deal arrangement that involves the pharma budgeting about $1.68 billion upfront to buy Ouro Medicines and for Galapagos to do early work on the candidate. While the Monday deal is atypical, it is possibly unsurprising considering Gilead owns 25% of Galapagos stemming from a partnership signed in 2019, and that the Belgian biotech spent much of 2025 in restructuring mode before ending the year with a thin pipeline. Both Gilead and Galapagos would be joining the T cell engager race for the first time, although they have experience in the autoimmune disease area that Ouro specializes in. | |
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by Kyle LaHucik
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Shionogi is doubling down on its sleep disorder pipeline by buying out Apnimed's half of their joint venture in the niche field. The Japanese pharma will pay $100 million upfront to buy the 50% equity interest held by its Boston-area partner, Shionogi said Tuesday. The pair teamed up in 2023 under a "$150 million transaction" to develop a jointly owned pipeline of sleep disorder medicines. The deal gives Shionogi full control of the pipeline under the joint venture named Shionogi-Apnimed Sleep Science, or SASS. That includes SASS-001 and SASS-002
(sulthiame). SASS-001 is a combo drug containing sivopixant, a P2X3 receptor antagonist, in Phase 2a for a type of sleep apnea. Meanwhile, the oral candidate SASS-002 was in-licensed from Germany-based company Desitin Arzneimittel last April. It is in Phase 2 for obstructive sleep
apnea. | |
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by Ryan Cross
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Quotient Therapeutics, a startup studying how tiny genetic typos cause some cells to get sick but allow others to remain healthy, has struck a partnership with Merck. The partnership will identify new drug targets for inflammatory bowel disease. It’s the third pharma deal Quotient has landed since it was founded by Flagship Pioneering in 2022. It comes with a $20 million upfront payment from Merck and it's eligible to receive milestones worth as much as $2.2 billion. Quotient searches for new genetic clues that promote or provide resistance to disease. But rather than just look for differences between people, as many scientists have done, it looks at individual cells, hunting for
discrepancies that accumulate from a lifetime of wear and tear. | |
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