Regulatory

With oral cyclic peptides offering small molecule convenience and antibody‑like selectivity, the modality is gaining momentum. But bioavailability below 1%, minimal PK data and fragile synthesis still slow progress. Viva Biotech’s experts outlined how hybrid synthesis, ADME/PK modeling and AI‑guided design are expanding what peptide therapeutics can reach.

Heading into an FDA hearing on Monday regarding the future of psychedelic treatments, public comments show wide support for further exploring the therapeutic potential of these compounds—to match rising support within the agency.

A year to the day after the Trump administration slashed $500 million in funding from mRNA-based programs, the FDA approved Moderna’s flu vaccine based on the technology. Weeks later, Moderna and Merck revealed positive Phase 3 results for their personalized mRNA-based cancer vaccine. In the words of one mRNA specialist, “science won.”

Newly solidified in their roles as the heads of CBER and CDER, Karim Mikhail and Michael Davis have been working for months to right the ship that had begun to capsize under former Commissioner Marty Makary. Meanwhile, Jared Seehafer will become the first-ever deputy commissioner focused on artificial intelligence.

The enrollment pause comes after BHV-7000 failed to show efficacy in a midstage depression trial late last year. The news is another regulatory hit for Biohaven after the FDA declined to approve its spinocerebellar ataxia treatment in November 2025.

With multiple drug pricing initiatives like Most Favored Nation now in force, drugmakers have to reinvent their commercial strategies to stay ahead of the fast-moving policy environment, according to a new report from Numerof & Associates.

In this episode of Denatured, sponsored by SK pharmteco, Jennifer Smith-Parker speaks to Arvind Singh, vice president and global head of supply chain. In this episode, we explore how CDMOs are reshaping supply‑chain strategy for a new generation of complex modalities.

The FDA’s proposal to offer 50% off application fees for drugs with early-stage trials conducted in the U.S. is unlikely to achieve the intended result. What biotechs really want is speed.

September has been a rough month already for Novo Nordisk, which canned two more late-stage trials of its embattled IL-6 inhibitor, and Novartis, which took Phase 3 hits in both cardiovascular and muscular dystrophy indications; Ultragenyx’s big bet in Angelman syndrome failed to yield benefit in Phase 3 but Ionis’ Pharmaceuticals nabbed the first targeted approval for Alexander disease; and on the business side, biopharma investment is back in a big way.

The decision to promote Michael Davis and Karim Mikhail from acting to permanent division heads comes as the FDA awaits the potential confirmation of Heidi Overton, President Donald Trump’s nominee for commissioner.