
The agency says that the decision aims to improve employee workflow and build on its previously implemented generative AI tool Elsa.

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.

Recent policy shifts in these two influential health technology assessment markets signal a broader regional move toward faster, more innovation-friendly access frameworks.

The agreement includes exemptions for UK-produced drugs and medical devices from Section 232 tariffs, but mandates a significant change to the UK's NICE value appraisal framework.

The agency’s decision is based on claims that the Covid vaccine was linked to the deaths of 10 children.

In the final part of this conversation, Dr. Bruce Leuchter, CEO of Neurvati Neurosciences, discusses new programs at FDA and how the neuroscience space is benefitting.

Jay Bregman, co-founder of Andel, closes out our conversation by explaining the impact government programs will have on GLP-1 coverage.

Dr. Bruce Leuchter, CEO of Neurvati Neurosciences, explains why psychedelics continues to be an area of interest.

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 approval of AstraZeneca’s Imfinzi in combination with perioperative FLOT chemotherapy marks the first immunotherapy regimen for resectable gastric and gastroesophageal junction cancers, delivering a 22% overall survival benefit and establishing a new standard of care.

The Trump administration has announced new negotiated Medicare prices for a second wave of blockbuster treatments, yielding an estimated $12 billion in savings for 2027, when compared to Medicare’s 2024 net spending.

Dr. Bruce Leuchter, CEO of Neurvati Neurosciences, continues his conversation, this time looking to the upcoming year in neuroscience.

In the final part of our conversation with Ryan Conrad, visiting fellow at the Center on Health Policy at the Brookings Institution, he discusses how FDA’s new program may or may not impact manufacturing pipelines.

The filing follows the completion of a pivotal study targeting abdominal conditions.

FDA approval of Itvisma, the first gene replacement therapy for adolescents, teens, and adults with SMA, is backed by Phase III data showing meaningful gains in motor function and a consistent safety profile across previously untreated and previously treated patients.

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.

Q&A with Krishna Kanumuri, CEO of Sai Life Sciences, on steering a contract development and management organization through growth, scale-up, and the shifting global supply chain in pharma.

Novartis is planing layoffs in Switzerland, along with plans to invest $80 million to enhance RNA treatment production and create new jobs by 2028.

As the federal government prepares to release newly negotiated Medicare drug prices, weight-loss blockbusters Ozempic and Wegovy remain in the spotlight, while CMS advances a model to cut Medicaid spending and broaden access to affordable treatments.

New technologies are helping the industry move toward more predictive and humane approaches.

In the second part of our conversation, Andel co-founder Jay Bregman how new GLP-1 options hitting the market will amplify existing coverage problems for the near future.

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.

Advice for making your story pitch stand out in this treatment space—where clearly conveying the "why it matters" is essential.

Novo Nordisk faces a drop in its stock after its Alzheimer’s trials studying semaglutide fail to show efficacy, raising concerns for future developments.

As affordability, access, and transparency reshape U.S. healthcare, manufacturers are rapidly redefining direct-to-patient drug distribution as a core strategic capability, one that demands fully integrated, data-driven platforms to secure control, competitiveness, and long-term value creation.

In the first part of this video, Dr. Bruce Leuchter, CEO of Neurvati Neuroscience, discusses which areas of neuroscience are exciting investors.

Ryan Conrad, visiting fellow at the Center on Health Policy at the Brookings Institution, continues his conversation about FDA ’s Priority Review Voucher Program, and explains what the industry can learn from the announced participants.