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In vivo gene editing scores US approval for hereditary angioedema
The FDA has approved Intellia Therapeutics’ in vivo CRISPR therapy lonvoguran ziclumeran (lonvo-z) via a biologics license application, following successful Phase III results reported in the New...
Big Pharma locks in next-gen autoimmune mRNA engager programs
Novartis has agreed to license Abogen Biosciences’ mRNA-encoded T-cell engager ABO2203 in a deal worth $575 million upfront, with total potential milestones of roughly $7.8 billion. The exclusive...
Sanofi and Regeneron extend long-acting immunology strategy
Sanofi is expanding its decade-long antibody partnership with Regeneron by adding four long-acting immunology candidates under an up-to-$8 billion collaboration. The companies will share...
Circuit-level data and AI validation partnerships move toward NSCLC companion diagnostics
CellCarta and Imagene AI expanded their partnership to help convert AI pathology capabilities into companion diagnostic (CDx) programs, with an emphasis on analytical validation, trial-enrollment...
FDA builds a dedicated clinical trial modernization office in CDER
The FDA opened a new clinical trial modernization office inside the Center for Drug Evaluation and Research (CDER), aiming to speed up and improve clinical trials used to support drug approvals....
New funds back late-stage-ready heart failure program
AnaCardio raised €62.5 million ($70.5 million) in a Series B round to advance its oral therapy AC01 into Phase IIb and toward Phase III readiness. The company described AC01 as a...
Clinical pipeline hit signals Aviceda shutdown after Phase 2 failure
Aviceda Therapeutics is winding down operations after a Phase 2 failure for its geographic atrophy program, according to a source familiar with the decision. The company had planned to move an eye...
Oncology biomarkers: blood inflammation scores forecast spread in vulvar cancer
Researchers reported that two simple blood-derived inflammation scores—systemic immune-inflammation index (SII) and systemic inflammatory marker calculations based on complete blood counts—may...
Neoadjuvant strategy delivers real-world tumor response gains in rectal cancer
A real-world study from Siriraj Hospital in Thailand reported that total neoadjuvant therapy improves tumor response rates in locally advanced rectal cancer outside controlled trial settings. The...
NIH grantmaking issues: fewer awards despite stable obligations
Grant Witness analysis found that NIH has issued fewer grant awards than the five-year norm, even while total funding obligations remain roughly level with last year. In fiscal year 2026 through...
Regulatory acceleration for longevity and clinical trial modernization
The FDA is set to broaden its regulatory science focus to aging and longevity, signaling that the agency plans to treat “healthspan” endpoints as a cross-cutting theme for future guidance. FDA...
Large pharma revenue bets on next-generation immuno-oncology and autoimmune platforms
Novartis agreed to an exclusive worldwide licensing deal with Abogen Biosciences for the company’s mRNA-encoded CD19xCD3 T-cell engager ABO2203. The transaction includes $575 million upfront and...
Oncology diagnostics and trial-enabling AI move toward clinical development
CellCarta and Imagene AI expanded their partnership to bring AI pathology into a more end-to-end path for NSCLC companion diagnostics. The companies said the collaboration covers assay validation,...
CRISPR approval for hereditary angioedema and implications for genome-editing durability
Intellia Therapeutics’ in vivo CRISPR therapy for hereditary angioedema cleared Phase III and received an FDA biologics license application approval. The one-dose treatment, lonvoguran ziclumeran...
Funding: clinical-stage heart failure program advances into Phase IIb readiness
AnaCardio closed a €62.5 million ($70.5 million) Series B round to advance its oral heart failure therapy AC01 into Phase IIb development. The Stockholm-based company said it will use the...
Regulatory and market signals: Pfizer’s Phase 3 vitiligo pill heads toward FDA and EMA submissions
Pfizer presented Phase 3 data for Litfulo (a daily pill) in vitiligo, reporting significant improvements in skin pigment measures in two pivotal studies. The results were presented during the...
Immunology dealmaking: Sanofi extends Regeneron antibody alliance toward next-gen Dupixent successors
Sanofi and Regeneron expanded their long-running immunology partnership to develop additional long-acting antibody drugs targeting the same pathways as Dupixent. The agreement includes a $1...
US policy pressure: NIH grant awards fall while funding uncertainty persists
Grantmaking at the National Institutes of Health appears to be issuing fewer awards as the agency navigates Washington’s debates over political control of grant funding. Grant Witness analysis...
Company pipeline risk: Aviceda winds down after Phase 2 setback
Aviceda Therapeutics is winding down after a Phase 2 failure in its geographic atrophy program, according to a source familiar with the decision. The company had planned to move an eye drug into...
Clinical caution on therapy timing and immune-related risks
A cancer case report described a rare but severe complication after one dose of an immunotherapy combination in a patient with stage IV lung adenocarcinoma. Clinicians reported four organ crises...