Don Tracy, Associate Editor

Jørgensen will step down after eight years as CEO, with a successor search underway while the company reaffirms confidence in its strategic plans amid recent market challenges.

Zynyz is the first and only FDA-approved first-line treatment for adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discusses how new findings highlight the need for simplified decision-making in lipid management and a stronger focus on achieving LDL-C targets to help prevent heart attacks and strokes.

Welireg marks the first FDA-approved non-surgical treatment option for locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma in patients over 12 years of age.

Emrelis is the first FDA-approved treatment for previously treated patients with locally advanced or metastatic non-squamous non-small cell lung cancer with high c-Met protein overexpression.

The collaboration will launch four development programs targeting key G protein-coupled receptors—GLP-1, GIP, and glucagon—to develop oral cardiometabolic medicines.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, explains why many high-risk Americans aged 50+ remain undertreated for cardiovascular disease, citing insurance gaps, risk misperceptions, and complex guidelines.

Under the agreement, GSK will acquire BP Asset IX, a subsidiary of Boston Pharmaceuticals, for up to $2 billion in total cash consideration, including $1.2 billion upfront and up to $800 million in milestone payments.

The decision follows ongoing investigations into serious adverse events primarily reported in elderly individuals who received the Ixchiq chikungunya vaccine.

Leandro Boer, MD, PhD, VP, US general medicines, Amgen, discusses new real-world data showing that most high-risk cardiovascular patients in the US are not starting or intensifying lipid-lowering therapy—and few are achieving guideline-recommended LDL-C targets.

Results from the Phase III REAL8 basket study found that once-weekly Sogroya was effective in children with growth disorders, including those born small for gestational age, with Noonan syndrome, or idiopathic short stature.

Armando Castro, partner, emerging companies, venture capital, Lowenstein Sandler, explains how repurposing GLP-1s and psychedelics for addiction treatment introduces unexpected patent challenges, liability concerns, and complex state-by-state regulatory hurdles.

Weight-loss and diabetes drugs dominated pharmaceutical spending last year, according to a new report by the American Society of Health-System Pharmacists, who warns of tariff-driven supply chain threats and continued growth in clinic drug costs.

The 700,000 square-foot facility is expected to create 400 high-wage manufacturing jobs once operational.

Merck Animal Health will invest $895 million to expand vaccine manufacturing and R&D in Kansas, while Lilly is committing $250 million to pharmaceutical innovation and workforce development through its extended partnership with Purdue University.

The Avmapki Fakzynja Co-Pack marks the first FDA-approved treatment for adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy.

Armando Castro, partner, emerging companies, venture capital, Lowenstein Sandler, explains how regulatory, patent, and reimbursement challenges are slowing venture investment in GLP-1 and psychedelic addiction therapies.

Interim results from the ongoing Phase III ASSURE trial demonstrated that Livdelzi maintained a consistent biochemical response in patients with primary biliary cholangitis.

Top-line results from two pivotal Phase III trials found that MR-107A-02 significantly reduced pain intensity following herniorrhaphy and bunionectomy surgeries compared to placebo.

Doug Long, VP, industry relations, IQVIA, discusses how soaring demand for GLP-1 therapies is driving reimbursement challenges, shifting distribution models, and expanding the drugs’ potential into new therapeutic areas.

The aura6000 system showed a 65% responder rate at 12 months in patients with obstructive sleep apnea, defined as achieving at least a 50% reduction in apnea-hypopnea index.

Will Pih, co-founder, Two Labs, explains how ongoing regulatory uncertainty is slowing clinical trial activity and hiring across the industry, prompting greater reliance on specialty pharmacy services and outsourced support.

Results from the Phase III MYR301 trial show that 36% of patients who achieved undetectable hepatitis delta virus levels when treated with bulevirtide maintained suppression for nearly two years.

Blake Powers, CEO, medigi, explains how digital tools, AI, and automation are streamlining access to biosimilars and cell and gene therapies, signaling a shift toward more tech-enabled, patient-centric care.

Fran Gregory, VP, emerging therapies, Cardinal Health, emphasizes the need for long-term outcomes tracking and robust health economic modeling to demonstrate the sustained value of advanced therapies and support future payment strategies.

Under terms of the deal, Alchemab will lead early Phase I trials for ATLX-1282 in amyotrophic lateral sclerosis, while Lilly will assume responsibility for further development and commercialization of the novel platform.

The Refusal to File letter comes despite the FDA’s prior encouragement to submit a supplemental biologics license application for Anktiva in patients with BCG-unresponsive non-muscle invasive bladder cancer with papillary disease.

Chip Parkinson, CEO, GiftHealth, explains how AI-powered data integration is bringing new hope to patients by revealing hidden access barriers, streamlining treatment pathways, and challenging outdated utilization management practices.

Tiara Green, president, Accessia Health, explains how empowering trusted local leaders and involving communities early are key to closing persistent gaps in preventive care and healthcare access.

Selarsdi, a biosimilar to Stelara, is approved for adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn disease, and ulcerative colitis.