
Real‑world data (RWD) is reshaping natural history studies by delivering longitudinal, patient‑level information that was previously only obtainable through costly prospective trials. Advances in artificial intelligence and natural language processing now allow rapid extraction of structured data from unstructured sources such as electronic health records and clinician notes. This enriched, diverse dataset enables researchers to define patient populations, identify biomarkers, and create external control arms, especially for rare diseases. The result is faster, more cost‑effective drug development with higher external validity.

The FDA approved Hernexeos through the national priority voucher program, a mechanism that fast‑tracks drugs addressing unmet medical needs. Industry leaders are evaluating direct‑to‑consumer (DTC) models to broaden access to HIV prevention tools, leveraging digital and telehealth channels. Additionally, the...

Gilead’s U.S. HIV prevention VP Ashley Gildea unveiled a direct‑to‑consumer campaign for Yeztugo, the first twice‑yearly injectable PrEP. The campaign, anchored by a music‑driven “One2PrEP” spot, aims to lift awareness among the estimated 2.2 million Americans who could benefit from PrEP...

Sarepta Therapeutics announced that CEO Douglas Ingram will retire by the end of 2026, triggering a formal succession search. The move follows a turbulent 2025 in which the company’s flagship gene therapy Elevidys was linked to two patient deaths, prompting...

Buzz Health President Joseph Kleiman says TrumpRx is advancing drug‑price transparency by giving consumers early visibility into prescription costs. He notes that real‑time pricing can help patients compare options but also warns that prices are dynamic and may change before...

Otsuka America became the first major pharmaceutical company to back psychedelic‑inspired medicines in 2020 through a partnership with COMPASS Pathways, and deepened that commitment by acquiring Mindset in 2023. The company is applying its long‑standing CNS expertise to develop serotonergic...

The FDA has approved Braftovi for patients with BRAF V600E‑mutant metastatic colorectal cancer, expanding targeted options in a genetically defined subset. The clearance underscores the momentum of biomarker‑driven oncology and combination‑therapy strategies. In parallel, Novo Nordisk announced a $2 billion partnership with Vivtex...

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) seized nearly 2,000 doses of illegal weight‑loss drugs in raids on sites in Lincolnshire and Nottinghamshire, marking its second major operation in four months. The confiscated products were labelled as containing tirzepatide...

The FDA’s crackdown on non‑approved or “copycat” GLP‑1 drugs is expected to push patients toward FDA‑approved therapies, elevating the role of retail pharmacies as primary access points. GoodRx’s head of retail network, David Graziano, says the company’s cost‑plus pricing model...

Novo Nordisk announced steep price cuts for its GLP‑1 diabetes and obesity drugs, aiming to broaden patient access amid intensifying pricing scrutiny. AbbVie is committing $380 million to expand API manufacturing capacity, reinforcing supply‑chain resilience. Bora Pharmaceuticals and GSK sealed a...

Pharma TV advertising is encountering stricter regulatory limits, especially since the Trump administration tightened rules around black‑box warnings and ad volume. While TV still reaches broad audiences, its effectiveness is waning as digital platforms enable far more precise, N‑of‑1 targeting....

Immuto’s CEO Faraz Choudhury explains that conventional target discovery, which focuses on gene mutations and protein abundance, overlooks disease‑specific protein conformations. The company’s platform maps surface protein conformations (SPCs) in living, patient‑derived models using high‑resolution mass spectrometry and AI‑driven analysis,...

Merck has created a standalone oncology business unit to confront the concentration risk posed by Keytruda, which now generates over half of its pharmaceutical sales and faces patent expiry around 2028. The restructuring treats organizational design as a strategic lever...

Jay Bregman, CEO of Andel, says the FDA’s pending crackdown on non‑FDA‑approved GLP‑1 compounds is long overdue and will target the burgeoning market of compounded semaglutide. He estimates roughly 1.5 million patients currently rely on these unapproved products, a figure he...

In a February 20, 2026 Pharm Exec Podcast, ZS CEO Pratap Khedkar, PhD, outlined three converging trends reshaping pharma: heightened AI integration, evolving ecosystem partnerships, and sweeping US‑driven policy reforms. Drawing on his nine‑year tenure leading ZS’s global pharmaceuticals practice and its advanced data‑science...