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How Recent FDA Actions Impact Sponsors

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AbbVie partners with Iambic on AI-driven drug discovery as Telix Pharmaceuticals moves to acquire ITM Isotope Technologies in a multibillion-dollar radiopharmaceutical merger, Novo Nordisk's CagriSema outperforms Eli Lilly's tirzepatide in a head-to-head diabetes trial, and Jen Lamppa of Inovalon discusses how real-time clinical data is reshaping trial recruitment.

AbbVie partners with Iambic to deploy its AI molecular superintelligence platform, while Telix Pharmaceuticals agrees to acquire radioisotope leader ITM.

Novo Nordisk reports that CagriSema delivered 12.4% average weight loss in a late-stage diabetes trial, outperforming tirzepatide's 9.1% at comparable doses.

Inovalon's Jen Lamppa on how real-time clinical data feeds validate patient eligibility at enrollment — reducing burden while improving accuracy.

FDA approves Ultragenyx's Fayuvi as the first treatment for Sanfilippo syndrome type A, Lisata Therapeutics acquires Marea Therapeutics as mAbxience partners with Sandoz on a hemophilia A biosimilar, and Joe Cunningham argues that executive drug-pricing deals alone won't fix costs.

Lisata Therapeutics acquires Marea Therapeutics and secures $225 million in concurrent financing, while mAbxience and Sandoz partner to develop and globally commercialize an emicizumab biosimilar.

FDA approved Ultragenyx's Fayuvi (rebisufligene etisparvovec-hopf) as the first treatment for MPS IIIA Sanfilippo syndrome type A.

Former Rep. Joe Cunningham (D-SC), now spokesperson for the Pharmaceutical Reform Alliance, argues that codifying Most-Favored-Nation pricing into law is the real fix for drug costs.

Former U.S. Representative Joe Cunningham (D-SC), spokesperson, Pharmaceutical Reform Alliance. dismisses the pharmaceutical industry's innovation argument against MFN pricing.

Inovalon's Jen Lamppa on why inaccurate self-reported data is clinical trial enrollment's costliest problem — and how RWD fixes it.

Five major pharma stories in one day — Novo's rebrand and AI bets, Bayer's 30-year CKD first, GSK's T-cell engager, and Sanofi's portfolio exit.

Inizio's Elaine Ferguson on why enabling purpose-driven employees to make a meaningful difference is as important as any formal talent strategy.

FDA approves Kerendia as the first new treatment for kidney disease in type 1 diabetes in decades, Novo, Roche, and Aethlon Medical strike major deals and mergers with Orbis Medicines, Dualitas Therapeutics, and North Immunology, and Thani Jambulingam of Saint Joseph's University examines the fight to control the GLP-1 patient journey.

As GLP-1 competition shifts from molecules to prescriptions, manufacturers, pharmacies, providers, and payers are racing to own the patient journey.

Orbis Medicines strikes a partnership with Novo, Dualitas Therapeutics enters collaboration with Roche, and Aethlon Medical has agreed to merge with North Immunology.
























