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PitchBook’s 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.
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The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The reinstatement of the generic drug policy office is the latest reversal of course for Robert F. Kennedy Jr.'s HHS, which also recently rehired FDA staff responsible for making travel arrangements and those involved in user fee program negotiations.
Two weeks of upheaval at the CDC culminated Monday in the complete reconstitution of the CDC’s Advisory Committee on Immunization Practices as HHS Secretary Robert F. Kennedy Jr. pens op-ed criticizing “conflicts of interest” he says exist on the current committee.
Avidity has been given the go-ahead by the FDA to request accelerated approval of delpacibart braxlosiran—potentially the first disease-modifying treatment for facioscapulohumeral muscular dystrophy—with an application in the second half of 2026.
The loss of special government employee status for four members of the CDC’s Advisory Committee on Immunization Practices follows the resignation of ACIP co-lead Lakshmi Panagiotakopoulos, who left in protest of a controversial change in COVID-19 recommendations for healthy children and pregnant women.
After a major shareholder pushed back, Keros is returning half of its capital to investors in a move that Guggenheim analysts called “a positive step forward.”
Merck’s enlicitide decanoate significantly lowered low-density lipoprotein cholesterol in two Phase III trials, unlocking what BMO Capital Markets called a “multi-billion dollar opportunity” for the pharma.
In what Guggenheim Partners called one of Metsera’s “critical program milestones” this year, its ultra-long-acting amylin injection MET-233i showed promising weight-loss after a little more than a month of treatment.
Empaveli reduced proteinuria by 68% versus placebo in glomerulopathy and glomerulonephritis, an effect that was sustained through one year of follow-up.
Atopic dermatitis manifests differently in patients with darker skin color, according to the companies, including subtler presentations and more severe and prolonged lesions compared to patients with lighter skin.
As multiple companies vie to expand on Alnylam’s success in commercializing RNAi therapeutics, the pioneering company has set a goal of targeting small interfering RNA to any tissue by 2030.