Some of the biggest news and trends captured in PharmaVoice’s newsletter this week. Sign up here to receive the newsletter daily.

Gilead’s expanding footprint in HIV

Gilead Sciences is broadening its HIV treatment franchise following a fresh approval from the U.S. Food and Drug Administration (FDA). The agency last week cleared a novel medication that combines two of Gilead’s existing HIV therapies into a single once-daily pill, intended for patients who wish to “simplify their treatment regimen,” according to a statement from Daniel O’Day, the company’s chief executive officer.

One of the active ingredients in the new tablet, lenacapavir, also serves as the backbone of Gilead’s twice-yearly injectable Yeztugo, which secured a landmark regulatory approval last year. To support Yeztugo’s commercial rollout, Gilead is directing outreach toward populations that have historically been difficult to engage, including the Black community — an initiative that PharmaVoice examined in detail this week.

Cell therapy deals plummet

Licensing activity in the cell therapy space has contracted sharply. According to a J.P. Morgan analysis, the sector recorded $583 million in upfront cash and equity deals during 2024. In the first half of this year, however, that figure failed to reach $1 million — a dramatic slowdown.

Early-stage funding has proven more resilient. Seed and Series A rounds in cell therapy attracted $383 million in the first half of 2026, surpassing the $339 million raised in all of 2025.

Despite this, CAR-T development remains in a state of uncertainty as researchers pursue next-generation breakthroughs. For the first time, developers are testing CAR-T therapies in autoimmune diseases, while other experimental approaches aimed at overcoming persistent manufacturing bottlenecks are still in clinical trials. This week, PharmaVoice delved into the technical details of those production challenges and assessed which innovations could shift the landscape.

FDA’s warm embrace of psychedelics

The FDA has become increasingly receptive to psychedelic drug developers. After issuing priority review vouchers to three psychedelic-based candidates earlier this year, the agency is now planning a public hearing that could further bolster the sector.

On Sept. 14, the FDA will convene a meeting on the future therapeutic use of psychedelic drugs, with the goal of aligning industry expectations with the agency’s ongoing development of regulatory guidance for these compounds.

Large pharmaceutical companies are also moving into the space. Most notably, Eli Lilly recently agreed to acquire AtaiBeckley and its portfolio of psychedelic candidates for mental health conditions, paying $2.8 billion upfront. This week, PharmaVoice explored the potential impact of Lilly and AtaiBeckley on social anxiety — an indication that has historically posed significant challenges for drug research and development.