Nicholas Jacobus

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.

Pharmaceutical collaborations expand as Flagship Pioneering expands its partnership with GSK, signing agreements with ProFound Therapeutics and Quotient Therapeutics, while Valo Health teams up with Merck KGaA to tackle disease challenges.

In today’s Pharmaceutical Executive Daily, learn how Moderna is expanding its manufacturing footprint in Massachusetts, GSK is advancing new research collaborations under the LTZ Fleming Initiative, and the FDA commissioner highlights how early and late movers can benefit from the National Priority Voucher program.

The FDA approves multiple new drugs, enhancing treatment options for cancer and other conditions.

Abbott's acquisition of Exact Sciences enhances cancer diagnostics and expands access to innovative screening and treatment solutions for patients worldwide.

In today’s Pharmaceutical Executive Daily, learn how Novo Nordisk is launching an introductory offer for Wegovy and Ozempic, AbbVie and Genmab gain FDA approval for Epkinly in follicular lymphoma, and Johnson & Johnson announces a $3 billion definitive agreement to acquire Halda Therapeutics.

GSK's collaborations leverage cutting-edge technology and scientific expertise to advance and accelerate research.

Moderna invests $140 million in its Norwood facility, creating hundreds of bio jobs while also enhancing manufacturing presence in the U.S.

Avadel Pharmaceuticals accepted Alkermes enhanced acquisition proposal for $2.3 billion, focusing on a key treatment's approval for added value.

Johnson & Johnson aims to enhance its oncology portfolio and innovate prostate cancer treatments by expanding its therapeutic pipeline through the acquisition.

In today’s pharmaceutical executive daily learn how Novo Nordisk is restructuring leadership to enhance scientific and commercial alignment, ABL Bio secures a major multi-program partnership with Eli Lilly, and the FDA launches its new Plausible Mechanism Pathway to accelerate drug development.

UnitedHealth Group appoints Dr. Scott Gottlieb to its board, enhancing leadership amongst a time in which the company looks to enhance its public outlook.

Eli Lilly partners with ABL Bio to research innovative therapeutics and expand its portfolio in cancer and CNS diseases through advanced bispecific antibody technology.

Jay Lalezari, CEO, CytoDyn, emphasizes how regulatory T cells play a crucial role in tumor progression by enabling cancers to evade immune detection.

In today’s Pharmaceutical Executive Daily, WeightWatchers plans to offer Novo Nordisk’s oral Wegovy pending FDA approval, FDA unveils a new Plausible Mechanism Pathway to accelerate drug reviews, and Ovid Therapeutics and Metagenomi share key third-quarter results and leadership changes.

Jay Lalezari, CEO of CytoDyn, explains how the CCR5 receptor has emerged as a pivotal target in metastatic cancers due to its dual role in promoting tumor cell migration and shaping a protective tumor microenvironment.

In today’s Pharmaceutical Executive Daily, Richard Pazdur is named director of FDA’s Center for Drug Evaluation and Research, Pfizer strengthens focus through strategic partnerships and spin-offs, and CMS launches a new initiative to reduce Medicaid drug costs.

FDA introduces a new drug approval process, the Plausible Mechanism Pathway, streamlining drug approvals for personalized therapies targeting rare genetic diseases without traditional trials.

Ovid Therapeutics and Metagenomi unveil leadership changes and financial results, highlighting strategic shifts and future growth opportunities in biotech.

Bristol Myers Squibb and Sarah Cannon Research Institute expanded their strategic collaboration, leveraging SCRI’s Accelero model to streamline operations, embed studies within community care settings, and extend cutting-edge oncology therapies to more diverse patient populations.

Following the removal of George Tidmarsh, HHS and FDA has appointed Richard Pazdur, M.D., director of CDER.