News
Billions of dollarsâ worth of cancer drugs are discarded each year. Manufacturers must refund Medicare for some of this waste. A data-driven approach offers a practical path to greater efficiency.
FEATURED STORIES
The first gene therapies approved to treat sickle cell disease in December 2023 are struggling on the market. But there are glimpses of forward momentum as Vertex and Genetix Bio provide updates.
After last yearâs âstampedeâ for FGF21 assets, the focus for the metabolic dysfunction-associated steatohepatitis space has shifted toward differentiated approaches, such as THR-ÎČ agonists and combination treatments, that seek to mirror the commercial success of Madrigalâs Rezdiffra.
Maintaining Americaâs momentum demands that policymakers resist policies that undermine research and development incentives.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Following the FDAâs refusal to review Modernaâs investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agencyâs handling of vaccines. Itâs a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
THE LATEST
The FDA outright refuses to review Modernaâs mRNA-based flu vaccine as CBER director Vinay Prasadâs conduct is scrutinized; Disc Medicine receives an unexpected rejection, which Prasad may also have had a hand in; Compass Pathways posts new late-stage data on its psilocybin-based depression drug; CDC is once again leaderless.
With leaner teams and tighter budgets, senior leaders can face tremendous strain as they juggle increased workloads and leadership responsibilities. In this column, Kaye/Bassmanâs Michael Pietrack discusses how pressure builds and what can ease it.
PitchBookâs 2025 biopharma VC analysis clocked $33.8 billion in capital dispatched in 2025, mainly to companies with later-stage programs ready to roll into the clinic.
Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressedâand thereâs more to come in 2026.
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.
Disc Medicineâs leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeksâ worth of such data instead of the requested 12, the company is delivering âin spades,â he said.
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
Following the successful late-stage study in wet age-related macular degeneration, Ocular plans to meet with the FDA to determine a regulatory path for Axpaxli.