Nicholas Jacobus is a content associate for Pharmaceutical Executive and can be reached at njacobus@mjhlifesciences.com.
Novo Nordisk’s NDA filing for CagriSema positions the first fixed-dose amylin–GLP-1 combination as a potential next-generation obesity therapy, backed by Phase III data showing more than 20% weight loss and signaling the company’s intent to extend its leadership beyond single-mechanism incretins.
In today’s Pharmaceutical Executive Daily, the FDA approves a new LDL-lowering therapy, Sanofi announces two strategic deals spanning Alzheimer’s disease and B-cell depletion, and the agency issues a national priority voucher tied to Tecvayli in multiple myeloma.
A pair of deal announcements underscore continued strategic reshuffling in biopharma, with Harbour BioMed striking a potentially billion-dollar collaboration with Bristol Myers Squibb to advance next-generation multispecific antibodies, while VYNE Therapeutics agreed to merge with Yarrow Bioscience to create a well-capitalized company focused on developing a first-in-class TSHR antibody for Graves’ disease and thyroid eye disease.
Pfizer’s shares slid after the company outlined its 2026 revenue and EPS guidance, reflecting investor unease over declining Covid-19 sales, looming patent expirations, and a capital allocation strategy that prioritizes pipeline investment over buybacks during a pivotal post-LOE transition period.
The agreement grants Sanofi with development and commercialization rights for ADEL-Y0, a potential first-in-class antibody therapy for Alzheimer's disease, and related backup compounds.
In today’s Pharmaceutical Executive Daily, new analysis highlights access gaps in the TrumpRx framework, the FDA awards a national priority voucher tied to Tecvayli in multiple myeloma, and Sobi announces a $1.5 billion agreement to acquire a gout therapy.
Lunit’s new collaboration with Daiichi Sankyo integrates AI-driven digital pathology tools into oncology translational research, aiming to accelerate biomarker discovery, refine patient stratification, and improve the efficiency of clinical development
In today’s Pharmaceutical Executive Daily, Eli Lilly reports positive topline Phase III results for retatrutide, the FDA expands Amgen’s Uplizna label into generalized myasthenia gravis subtypes, and a new analysis explores whether pharmaceutical manufacturing is truly moving back onshore.
The FDA’s approval of Lerochol introduces a once-monthly, subcutaneous PCSK9 inhibitor for lowering LDL cholesterol in adults with hypercholesterolemia.
Sobi’s $1.5 billion acquisition of Arthrosi Therapeutics positions the company for long-term growth and strengthens its gout treatment portfolio.
Ascension of agonist class touching all parts of the market—from science to strategy.
In today’s Pharmaceutical Executive Daily, new analysis outlines what it may truly cost to fix the biopharma ecosystem, the FDA approves Waskyra for patients with Wiskott-Aldrich syndrome, and OTR Therapeutics enters a strategic collaboration with Zealand to develop novel metabolic disease therapies.
Why the new wave of direct-to-consumer access represents more than a passing trend.
Lilly’s first Phase III results for retatrutide show unprecedented weight loss and marked reductions in osteoarthritis pain, underscoring the potential of its triple-agonist therapy to reshape treatment for obesity and related metabolic conditions.
Waskyra’s FDA approval marks a milestone for rare disease care and for Fondazione Telethon, establishing the first nonprofit-led ex vivo gene therapy to reach market after decades of research.
In today’s Pharmaceutical Executive Daily, the FDA introduces a new superiority standard for future CAR-T approvals, Relation Therapeutics and Novartis form a $1 billion multi-program collaboration targeting atopic diseases, and new insights reveal how payers are shaping expectations for Phase III trial design.
FDA’s approval of Augmentin XR as the first therapy cleared under the new National Priority Voucher Pilot Program signals a decisive push to strengthen domestic antibiotic manufacturing, accelerate critical drug reviews, and stabilize long-strained U.S. antimicrobial supply chains.
In today’s Pharmaceutical Executive Daily, new analysis outlines how EMA support programs help lower drug market entry costs, early real-world data show sustained remissions with Carvykti in relapsed or refractory multiple myeloma, and Pfizer signs an exclusive collaboration with Yao Pharma to advance oral small-molecule GLP-1 agonists.
Relation Therapeutics and Novartis launch a multi-program alliance combining Relation’s AI-powered, patient-derived discovery engine with Novartis’s immuno-dermatology capabilities.
Pfizer’s exclusive partnership with Yao Pharma secures global rights to the oral GLP-1 agonist YP05002, advancing its cardiometabolic pipeline.
In today’s Pharmaceutical Executive Daily, the FDA greenlights an expanded use of Breyanzi, Eli Lilly reports Jaypirca met its primary endpoint in a head-to-head Phase III trial against Imbruvica for CLL/SLL, and new analyses highlight how health systems are strengthening partnerships to support cell and gene therapy commercialization.
Carvykti’s emerging Phase III data shows that a single early-line infusion can deliver durable, treatment-free remissions lasting beyond 30 months for patients with relapsed or refractory multiple myeloma.
Jaypirca matched response rates for Imbruvica with potentially improved survival in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma.
FDA’s approval of Bristol Myers Squibb’s Breyanzi as the first CAR T therapy for relapsed or refractory marginal zone lymphoma underscores the therapy’s expanding leadership in B-cell malignancies, backed by compelling Phase II data
In today’s Pharmaceutical Executive Daily, the FDA appoints Tracy Beth Høeg as acting CDER director, health systems explore new commercialization partnerships for cell and gene therapies, and Aidoc submits a breakthrough-designated multi-triage AI device for FDA approval.
The agency based its approval off results collected from the Bruin CLL-321 trial.
The agency also named a new head of its Office of Nonprescription Drugs.
In today’s Pharmaceutical Executive Daily, Regeneron launches a $150 million gene editing collaboration with Tessera Therapeutics, the FDA begins agency-wide deployment of new agentic AI tools, and a new report suggests Richard Pazdur is stepping down as director of CDER.
The claim is based on recent survey results from Nationwide.
The former FDA oncology chief is set to resign by the end of the month.
