Some of the biggest news and trends captured in PharmaVoice’s newsletter this week. Sign up here to receive the newsletter daily.
Roche’s AI ambitions and looming challenges with the tech
Pharma wants AI agents because they can do more than answer a question. They can choose tools, gather evidence and keep a workflow moving.
That promise is pushing the industry closer to autonomous R&D. Roche said this week it has begun building autonomous AI-driven labs, while Nvidia rolled out new safeguards aimed at containing AI agents that stray beyond intended boundaries.
Those developments capture the same tension: The more useful an agent becomes, the more consequential it is when the system gets something wrong.
This week, we looked at how AI-agent errors can move through drug R&D, where human checkpoints matter most and why autonomy changes the risk.
Biohaven’s pivotal pause in epilepsy and R&D in the space
There’s a lot riding on Biohaven’s epilepsy drug opakalim.
After clinical setbacks in CNS indications including depression and spinal muscular atrophy, Biohaven was thrown a financial lifeline in August when it secured a major cash infusion from SK Biopharmaceuticals – the South Korea-based pharma licensed Biohaven’s Kv7 ion channel platform and opakalim in a deal worth up to $795 million. But just just over a week later, the FDA asked Biohaven to pause new enrollment in one of opakalim’s phase 3 trials to answer questions over the presence of a specific kind of metabolite that cropped up during rodent studies.
That pause could delay a key readout for opakalim that could ultimately be necessary for approval, according to RBC Capital Markets analyst Leonid Timashev.
The readout is also one of many closely watched trials in the epilepsy space that could reveal how well new technologies are working against the condition. This week, we took a look at the next wave of up-and-coming therapies in epilepsy and if researchers are finally closing in on a disease-modifying treatment.
Bavarian’s global vaccine goals under its new CEO
The FDA’s historic nod for the first-ever mRNA flu vaccine in August might have looked like an about-face for an agency working in the oft vaccine-skeptical environment of the second Trump administration. But behind the scenes, there are still plenty of regulatory roadblocks being thrown in front of vaccine makers.
The flow of federal guidance around vaccines has been in flux in the last year, according to reporting by the Associated Press. Now, medical societies have begun filling the gap with their own recommendations for patients and providers, adding another layer of uncertainty for vaccine developers.
There is still a way to make it in the vaccine space, though. For Bavarian Nordic, growth has come from a portfolio of shots for travel-related diseases. And it’s from that foundation that the company wants to grow into a larger global vaccine player. This week, we looked at what Bavarian’s incoming CEO will need to navigate to help the company meet those ambitions.
