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.
In today’s Pharmaceutical Executive Daily, Eli Lilly reduces the price of Zepbound single-dose vials for self-pay patients, a new report claims the FDA is planning changes to its vaccine approval process following assertions of COVID vaccine–related deaths, and Korea and Australia reorient their pharma launch strategies toward broader regional market opportunities.
The collaboration will focus on the development of TSRA-196 as a treatment for Alpha-1Antirypsn Deficiency (AATD).
The agency says that the decision aims to improve employee workflow and build on its previously implemented generative AI tool Elsa.
In today’s Pharmaceutical Executive Daily, Novo Nordisk files for FDA approval of a higher-dose Wegovy injectable using a priority review voucher, the US and UK agree to eliminate tariffs on pharmaceutical products, and CMS publishes major price cuts for 15 high-cost Medicare drugs under the latest IRA negotiation round.
The price adjustment to the popular GLP-1 agonist is part of an ongoing effort to expand access to patients with obesity by making medicines more affordable.
The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.
In today’s Pharmaceutical Executive Daily, Novartis plans to eliminate 550 positions at a major Swiss site, the FDA authorizes the first gene therapy for adolescents and adults with spinal muscular atrophy, and industry experts weigh in on how next-generation CDMOs are evolving to meet rapid market change.
The company submitted the new dosage for approval based on its Phase III trial results.
The filing follows the completion of a pivotal study targeting abdominal conditions.
In today’s Pharmaceutical Executive Daily, Novo Nordisk faces market pressure after a late-stage trial setback, Moderna takes out a $1.5 billion loan to support its long-term growth plan, and Medicare moves closer to releasing negotiated prices for 15 widely used, high-cost medicines.
Novartis is planing layoffs in Switzerland, along with plans to invest $80 million to enhance RNA treatment production and create new jobs by 2028.
In today’s Pharmaceutical Executive Daily, learn how Tesaro is suing AnaptysBio over alleged contract breaches, Flagship Pioneering and Valo Health announce major new collaborations, and why integrated direct-to-patient drug distribution is becoming a strategic imperative.
Moderna secures a $1.5 billion loan to enhance financial flexibility while targeting a 10% revenue growth by 2026, focusing on innovative mRNA therapies.
Novo Nordisk faces a drop in its stock after its Alzheimer’s trials studying semaglutide fail to show efficacy, raising concerns for future developments.
In today’s Pharmaceutical Executive Daily, learn how Abbott is acquiring Exact Sciences in a major diagnostics deal, Novartis is building a new manufacturing hub in North Carolina, and the FDA is rolling out a wide batch of drug approvals.
Tesaro and AnaptysBio engage in legal battles over alleged breaches of their 2014 partnership agreement regarding Jemperli.
