Nicholas Jacobus is a content associate for Pharmaceutical Executive and can be reached at njacobus@mjhlifesciences.com.
In today’s Pharmaceutical Executive Daily, we cover GSK’s supplemental application to update the label for Leucovorin, the FDA’s complete response letter to Otsuka and Lundbeck’s sNDA for Rexulti, and the medical community’s response to President Trump’s claims linking Tylenol use to autism risk.
GSK seeks FDA approval for Leucovorin to treat cerebral folate deficiency and autism symptoms, promising new hope for affected children.
Scholar Rock navigates FDA's Complete Response Letter for Apitegromab, aiming for swift resubmission to address spinal muscular atrophy treatment needs.
Madeline Verbeke, Senior Clinical Advisor, MMIT, touches on injectable and oral GLP-1's impact on the clinical landscape, and the clinical and scientific hurdles oral GLP-1 formulations need to overcome to gain comparable traction.
Rob DeWig, VP of Healthcare Sales at Inmar, touched on the current operational challenges that health system pharmacies face.
In today’s Pharmaceutical Executive Daily, we cover Biogen’s acquisition of Alcyone Therapeutics to expand its drug delivery solutions, the FDA’s expanded approval of Incyte’s Opzelura for atopic dermatitis in young children, and Pfizer’s move to acquire Metsera to strengthen its obesity and cardiovascular pipeline.
FDA denies approval for Rexulti in PTSD treatment, citing insufficient evidence despite clinical trials. Otsuka and Lundbeck plan next steps.
Pfizer acquires Metsera for $4.9 billion, enhancing its portfolio in obesity and cardiovascular treatments with innovative therapies and strong clinical potential.
Rob DeWig, VP of Healthcare Sales at Inmar, touches on how access to 25% of benchmarking data from national pharmacy claims change for Premier Members.
In today’s Pharmaceutical Executive Daily, we cover how pharma companies can scale AI pilots into enterprise-wide value, GSK’s plan to invest $30 billion in U.S. biopharma capacity, and Novo Nordisk’s clinical trial success with oral Wegovy.
CDC vaccine advisers delay Hepatitis B schedule changes while recommending separate vaccines for measles, mumps, rubella, and chickenpox amid safety concerns.
Biogen expands its drug delivery solutions by acquiring Alcyone Therapeutics, enhancing patient-centered therapies with the innovative ThecaFlex DRx system.
VectorY Therapeutics partners with Shape Therapeutics to advance innovative therapies for neurodegenerative diseases using SHP-DB1 technology and AAV5 capsids.
Rob DeWig, VP of Healthcare Sales at Inmar, touches on looming DSCSA enforcement and the impact of Inmar's reconciliation tools.
In today’s Pharmaceutical Executive Daily, we explore how AI is disrupting higher education and career pathways, AllRock Bio’s $50 million Series A funding to advance its lead molecule, and FDA warning letters issued to Novo Nordisk, Eli Lilly, and Hims over misleading drug advertising.
Former CDC director Susan Monarez raises alarms about potential changes to childhood vaccine schedules, warning of increased health risks for children.
Novo Nordisk's shares rise as Phase III trial shows its oral Wegovy pill achieves significant weight loss, offering a new option for patients.
Roche strengthens its pipeline by acquiring 89bio and its promising MASH treatment, Pegozafermin, enhancing options for metabolic disease therapies.
Rob DeWig, Vice President of Healthcare Sales, Inmar, touches on the impact of Inmar and Premier's expanded agreement on the broader healthcare and pharmacy ecosystems.
In today’s Pharmaceutical Executive Daily, we cover Lilly’s orforglipron as a prime candidate for FDA fast-track approval, Merck and Daiichi Sankyo’s breakthrough therapy designation for R-DXd in ovarian cancer, and Novo Nordisk’s EU approval of Rybelsus for reducing cardiovascular risk.
FDA warns major pharmaceutical companies to improve transparency in drug advertising, addressing misleading claims and enforcing stricter regulations.
VarmX partners with CSL to advance VMX-C001, a groundbreaking treatment for patients on FXa DOACs, enhancing surgical outcomes and patient care.
Eli Lilly's Orforglipron shows superior results in glycemic control and weight loss compared to oral semaglutide in recent clinical trials.
In today’s Pharmaceutical Executive Daily, we cover AbbVie’s stock jump following a Rinvoq litigation settlement, new insights into the ROI of specialty pharmacy adherence programs, and a closer look at what true innovation in PBM management entails.
AllRock Bio secures $50 million to advance Roc-101, a promising treatment for pulmonary hypertension, aiming to transform patient care.
Novo Nordisk's Rybelsus gains EU approval for cardiovascular benefits, enhancing treatment options for type 2 diabetes and improving patient outcomes.
Eli Lilly's Orforglipron may become the first drug fast-tracked under the FDA's new program, promising quicker access for weight loss treatment.
In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s return-to-office mandate from its CEO, the evolving COVID-19 vaccine landscape in 2025, and Capsida’s decision to halt a gene therapy trial following a patient death.
AstraZeneca pauses its £271 million Cambridge investment, reflecting growing concerns over the U.K.'s life sciences sector and government support.
Novartis partners with Monte Rosa Therapeutics in a $5.7 billion deal to develop innovative treatments for immune-mediated diseases using AI technology.
