Pharma giant Gilead Sciences announced Monday a $7.8 billion agreement to acquire Arcellx, a cancer biotech in which it already held an 11.5% stake from a 2022 partnership to co-develop and co-commercialize the CAR-T therapy anitocabtagene autoleucel (anito-cel). The FDA has accepted the BLA for anito-cel, which targets BCMA in relapsed/refractory multiple myeloma, with a PDUFA action date set for December 2026. The deal underscores Gilead's CAR-T expansion strategy beyond its Kite Pharma subsidiary's Yescarta and Tecartus, and comes as biotech M&A momentum accelerates in 2026 driven by patent cliffs and innovation hunger from Big Pharma.
The Daily Upside / Technical.ly / BioSpace·Feb 243 min read
The FDA is dropping its decades-old default requirement for two pivotal trials to approve new drugs. Published in the New England Journal of Medicine on February 18, the new guidance makes one well-designed trial the standard, citing real-world evidence, post-marketing surveillance, and "powerful alternative ways to feel assured that our products help people" in 2026. Critics worry about safety; proponents see faster access for patients.
Key PDUFA dates loom for oral AML therapies, BTK inhibitors, and tabelecleucel — a first-in-class therapy for EBV-positive posttransplant lymphoproliferative disease. February 8 passed with REGENXBIO's RGX-121 gene therapy for mucopolysaccharidosis type II (Hunter syndrome) showing an 82% reduction in heparan sulfate levels through 1 year in pivotal trial data. The oncology approval pipeline remains robust despite regulatory scrutiny.
Researchers have engineered CAR-T cells to express de novo-designed targeted protein degraders (bioPROTACs) that selectively degrade DNMT3A, a key epigenetic regulator. By combining protein degrader technology with cellular immunotherapy, the study demonstrates a novel approach to reprogramming CAR-T cells for enhanced therapeutic performance. This convergence of two cutting-edge modalities — targeted protein degradation (PROTACs/molecular glues) and engineered cell therapy — opens a new frontier in immuno-oncology, potentially addressing resistance mechanisms and improving CAR-T durability.
Scientists have developed a drug-controllable CAR-T system that acts as an on/off switch at the cell–cell contact level. Unlike earlier approaches that block signaling or induce cell death, this switch preserves CAR-T cells for continued treatment — enabling enhanced safety without permanently losing therapeutic cells. If validated, it could become standard for managing cytokine release syndrome (CRS) without sacrificing efficacy.
The AJMC examines whether FDA safety concerns and the rise of bispecific antibodies (BiTEs) will slow CAR-T adoption. While bispecifics offer off-the-shelf convenience and recruit endogenous T cells, CAR-T remains unmatched for deep, durable responses in heavily pretreated patients. The field faces a crossroads: complementarity or competition.
One of the most-watched events of the quarter is happening today: Nvidia is set to report fourth-quarter and fiscal 2026 earnings after market close on Wednesday, February 25. The AI bellwether's results are expected to show 71% earnings-per-share growth on $65.9 billion revenue, driven by relentless demand for Blackwell GPUs. Stock markets rallied Tuesday in anticipation, with the Dow lifting 800 points. Investors are zeroed in on guidance, data center growth, and whether DeepSeek's low-cost AI models threaten Nvidia's dominance. A selloff on strong fundamentals could create a rare entry point — or validate current valuations if guidance impresses.
Tuesday's stock market session saw a broad rally across indexes as investors positioned themselves ahead of Nvidia's earnings and President Trump's State of the Union address. Tariff concerns that drove the Dow down 800 points Monday evaporated, replaced by optimism around AI and tech. Market sentiment remains fragile but bullish short-term.
Nvidia shares are up in 2026 even as broader tech faces volatility. Cautious investors may want to wait for Wednesday's financial update to validate current expectations or capitalize on a selloff if fundamentals remain strong. The stock's valuation hinges on sustained AI infrastructure spending and Blackwell ramp-up success.
Anthropic has publicly accused three Chinese AI companies — DeepSeek, Moonshot, and MiniMax — of conducting "industrial-scale campaigns" to illicitly extract Claude's capabilities and improve their own models through a technique called distillation. The company flagged evidence of distillation since early 2025, when China's first DeepSeek model launched with striking similarities to ChatGPT. OpenAI made similar accusations in January, stating DeepSeek "may have improperly distilled" its models. While distillation is common within firms to create smaller, cheaper versions, Anthropic alleges these Chinese labs queried Claude repeatedly to reverse-engineer its strengths in coding, reasoning, and tool use — effectively free-riding on billions in US R&D investment. The allegations bolster calls for tighter AI export controls and chip restrictions.
CNBC / CNN / NBC News / India Today·Feb 244 min read
While Northern Italy matches Paris pricing, southern regions significantly undercut both. Sicily, Puglia, and Calabria offer 30–40% lower costs than Tuscany, with equally stunning food, history, and coastline. Puglia — the heel of Italy's boot — has a reputation for making visitors feel like they've discovered something most people haven't: trulli houses dotting the Itria Valley, olive groves centuries old, beaches truly turquoise, and food that is simple, perfect, and entirely unforgettable. It's the type of travel that rewards slowing down, and one of the rare places where a return visit deepens the experience. With Italy seeing a 30% increase in international bookings for 2026, savvy travelers are choosing affordability without compromise.
Ein Stück über den Wald und seine Bewohner in Laut- und Gebärdensprache läuft heute, Mittwoch, 25. Februar, um 10:30 Uhr im Dschungel Wien. Die Produktion richtet sich an Kinder und Familien und macht den Wald auf der Bühne erlebbar — mit inklusivem Zugang für gehörlose und hörende Kinder gleichermaßen. Weitere Vorstellungen folgen in den kommenden Tagen. Das FALTER Kinder-Eventprogramm wird wöchentlich aktualisiert und bietet einen Überblick über Theaterproduktionen, Museumsworkshops und Outdoor-Events für Familien in Wien.