The US government shutdown that began this week has immediate consequences for biotech: the FDA cannot accept any new regulatory submissions requiring user fees during the funding lapse. While 86% of FDA staff remain on duty for essential safety functions — outbreak monitoring, high-risk recalls — the freeze on new drug, biologic, and device applications creates a backlog that could delay approvals for months even after reopening. Inspection bottlenecks compound the problem, with a "ripple effect" on supply chains and PDUFA timelines.
Pharmaceutical Executive / Pharma Technology·Feb 233 min read
Novo Nordisk's oral semaglutide (Wegovy pill) has been approved as the first GLP-1 receptor agonist in pill form for weight loss. The once-daily tablet launched in the US in January 2026 and global regulatory filings are underway. A potential game-changer for the obesity market — removing the injection barrier that limited uptake.
In SEC filings this week, specialist fund Redmile Group added heavily to Praxis Precision Medicine (+$600M stake, stock +320% YoY), Immunome ($12M, +120%), Scholar Rock ($49M), and Nurix Therapeutics ($63M). The bets span neuroscience, immuno-oncology, and targeted degraders — a clear signal of institutional conviction in clinical-stage biotech.
A striking bioRxiv preprint from this weekend introduces designed protein degraders (bioPROTACs) expressed directly within CAR-T cells to target DNMT3A, a key epigenetic regulator of T-cell exhaustion. Unlike small-molecule PROTACs, these are genetically encoded — the CAR-T cell manufactures its own degrader. Early data show enhanced stemness and persistence phenotypes. If validated, this approach merges two of the hottest fields in oncology — targeted protein degradation and cellular therapy — into a single platform.
Early results for KLN-1010, a next-generation BCMA-targeted CAR-T, demonstrate MRD negativity in heavily pretreated patients carrying high-risk cytogenetics (del17p, gain 1q, t(4;14)). Notably, CAR-T cell persistence was maintained — a key differentiator from earlier constructs that waned over months.
Data presented at ASH 2025 confirm what the field has suspected: cilta-cel in earlier lines of myeloma treatment produces superior CAR-T expansion, deeper responses, and more durable remissions. Fitter immune systems and less exhausted T cells are the likely drivers. The case for moving CAR-T upstream strengthens.
Nvidia's fiscal Q4 earnings on February 25 will set the tone for tech and AI stocks this week. Analysts expect a 71% rise in EPS on revenue of $65.9 billion, driven by insatiable Blackwell demand. CEO Jensen Huang called order flow "off the charts." But the stock is roughly flat year-to-date, suggesting the market wants proof that the AI capex boom translates into sustained growth. Also on deck: wholesale inflation data, consumer confidence, and the Chicago PMI — macro signals that could amplify or dampen the Nvidia reaction.
The Supreme Court's ruling to overturn presidential tariff authority under IEEPA sent tech stocks higher on Friday. Teradyne and Cognex surged after blowout Q4 results. The ruling removes a key overhang that had weighed on trade-sensitive sectors for months.
Billionaire Stanley Druckenmiller's latest 13F reveals he continues to avoid Nvidia despite the AI boom. Instead, he added shares of what analysts call the cheapest Magnificent Seven stock — a contrarian play that bets on AI monetization rather than chip demand alone.
The 61st International Art Exhibition — themed In Minor Keys — runs May 9 through November 22, 2026, across the Giardini, Arsenale, and venues throughout Venice. National pavilions are already announcing artists and curatorial concepts. For those planning a Venice trip this year, the Biennale transforms the city into one of the world's most ambitious art experiences. Combine it with the day-tripper fee (still in effect) and you'll want to plan accommodation well ahead — especially for the opening weeks in May.
Designboom / La Biennale di Venezia·Feb 193 min read
Italian aviation strikes initially planned for during the Winter Olympics have been postponed to February 26 and March 7. Airports affected include Milan Malpensa, Rome Fiumicino, Venice Marco Polo, and Verona. If you're flying in or out this week, check your airline for schedule changes and build in a buffer day.
A new 2026 Italy budget guide highlights the south as the value play: Sicily, Puglia, and Calabria offer equally stunning food, history, and coastline at 30–40% less than northern Italy or Tuscany. International bookings for Italy are up 30% for 2026, so early planning pays off — especially for family-friendly beach towns in the Salento region.