Pharmaceutical Executive

FDA grants accelerated approval to INOVIO’s Voceryq to reduce surgical burden in recurrent respiratory papillomatosis, Brox.AI’s Hamish Brocklebank on the three levels of digital clone use cases in pharma, and CytoDyn’s Dr. Jay Lalezari on his path from HIV clinician to CEO.

In this episode of the Pharmaceutical Executive podcast, Scott LaGanga, executive vice president of state advocacy at PhRMA, discusses the expanding influence of state policymaking on drug pricing, pharmacy benefit manager reform, and efforts to translate policy changes into lower out-of-pocket costs for patients. Joining Mike Christel, group managing editor, MJH Life Sciences, LaGanga also dives into the potential impact of tomorrow's U.S. midterm elections in shaping the next wave of drug pricing policy in state capitals as much as in Washington.

Noting the high stakes, LaGanga explains why turnover in governors’ offices and state legislatures puts fresh urgency on educating policymakers about the pharmaceutical supply chain — and how decisions in states can move quickly and spread across the country. He also considers how the presidential campaign cycle that follows could bring local health care access and affordability concerns further into the national debate.

Bristol Myers Squibb discloses a patient death in its Phase I CAR-T multiple sclerosis trial, Pathos AI launches multi-year collaborations with Bristol Myers Squibb and Tempus AI to advance Alzheimer’s drug development, and health economist Dr. Nadine Zawadzki speaks with The Ron Lanton Report on how value is defined across healthcare.

Pharmaceutical and health economist Dr. Nadine Zawadzki, Senior Director, FTI Consulting joins the Ron Lanton Report to discuss how value is defined and measured across healthcare.

Treasury proposes adding biotechnology to its Outbound Investment Security Program, a pharma funding roundup covers Gilead’s $1.275 billion acquisition of an oral IL-23R inhibitor from PepStar and Zymeworks’ licensing deal with Roche, and Incubate’s John Stanford on why MFN is an offer pharma can’t refuse.

Biopharma manufacturing today is being asked to move faster, accommodate increasingly complex modalities, and respond more readily to changing development timelines and demand forecasts — all while maintaining reliable, compliant, and cost-effective supply. In this episode of the Pharm Exec Podcast, Dave Maraldo, Ph.D., executive vice president and president of the Merck Manufacturing Division, draws on 27 years at the company to explore that evolution. He discusses Merck’s major U.S. capacity investments; its approach to balancing internal capabilities with strategic manufacturing partners; and the closer integration of research, development, and production.

Joining Mike Christel, group managing editor, MJH Life Sciences, Maraldo also examines the practical impact of digital tools and artificial intelligence and how Merck is building greater agility and resilience into its global supply network. He reflects ahead as well on what the next generation of manufacturing talent will require and why he thinks patient needs will move closer and closer to the shop floor.

FDA grants Ultomiris accelerated approval for primary immunoglobulin A nephropathy, a pharma funding roundup covers Alcon’s $550 million acquisition of Neurotech and AI Proteins’ collaboration with Astellas, and Incubate’s John Stanford on which therapeutic areas MFN deals might hit hardest.

A new ICER and West Health report finds median drug launch prices climbed to $257,000, the FDA approves GSK’s Hibsago as the first functional-cure therapy for chronic hepatitis B, and CSL names Deborah Waterhouse as CEO and managing director.

METiS TechBio and Eli Lilly collaborate on next-generation LNP delivery technology, Incubate’s John Stanford on how MFN deals may shape future pharma decisions, and the FDA grants accelerated approval to GSK’s Jemperli for MSI-H/dMMR locally advanced rectal cancer.

Merck KGaA, Darmstadt, Germany, acquires Silence Therapeutics for $1.3 billion, Hansoh Pharma and Roche expand their ADC partnership in a deal worth over $15 billion, and an EMA panel backs Lilly’s Foundayo for obesity and type 2 diabetes in Europe.

Gilead and Vir Biotechnology strike a $1.87 billion T-cell engager collaboration, and Fox Rothschild’s Marc Wagner examines what slows manufacturers’ response to rising drug demand and how compounding pharmacies help fill the resulting gaps.

Experts warn prediction markets are exposing gaps in pharma vendor confidentiality agreements, Roche licenses Rona Therapeutics’ obesity RNAi candidate while Pfizer partners with Enodia Therapeutics on Sec61 inhibitors, and PaxSafe’s Mark Talens makes the case for acting on imperfect supply chain data.

Bausch + Lomb names Thomas Appio interim CEO as Brent Saunders departs, a Pharm Exec interview explores how AI is reshaping entry-level apprenticeship in professional services, and a LogiPharma 2026 conversation makes the case against waiting for perfect data to deploy AI in pharma supply chains.

The FDA approves Roche’s Tecentriq for a subset of colon cancer patients, TRexBio and Retension Pharmaceuticals price new IPOs, and a Pharmaceutical Executive feature examines what it takes to turn precision medicine’s biological gains into deliverable therapies.

Ultragenyx sells a rare pediatric disease priority review voucher for $210 million, Viatris acquires Pacira BioSciences for $1.65 billion, and Peter Young surveys a steadying biopharma outlook.

Caribou Biosciences discontinues its two allogeneic CAR-T programs, Kamal Biswas makes the case for continuous quality management maturity, and FDA approves Pfizer’s Tukysa as a first-line maintenance therapy in HER2-positive breast cancer.

Shionogi, Gate Bioscience, and Alector post a trio of new deals, Rajul Jain makes the case for social listening as a medical affairs strategic tool, and Doceree's Vijay Adapala argues that HCP engagement is a systems-design problem, not a communications one.

Can artificial intelligence help turn what many believe is clinical development’s biggest variable — and most prevailing bottleneck — into a more predictable process? In this episode of the Pharm Exec podcast, Matt Walz, CEO of Trialbee, a patient recruitment company, joins Mike Christel, group managing editor, MJH Life Sciences, to discuss how AI is enhancing medical screening, clinical workflows, and enrollment planning. The conversation explores the need for clearer regulatory expectations, human oversight, and workforce training — and why predicting enrollment costs and timelines, Walz believes, could offer one of AI’s most consequential opportunities in clinical trials.

Walz also shares how Trialbee is deploying AI on both the patient-facing and operational sides of its business and explains how conversational tools are helping teams move from the world of dashboards to more specific answers.

Jewel Jones warns that pharma catches patient disengagement too late, CSL and Alentis Therapeutics join Jiangsu Nhwa and Somnivera in a day of new licensing deals, and Corxel's Bo Liang calls GLP-1's leap to bariatric-surgery-level efficacy the biggest surprise in obesity medicine.

Foghorn Therapeutics and Eli Lilly discontinue their SMARCA2 degrader program, Novartis licenses Abogen's autoimmune mRNA therapy while AstraZeneca, Daiichi Sankyo, and Summit Therapeutics team up on a breast cancer combination trial, and Corxel's Bo Liang makes the case for oral GLP-1 therapies.