In the first Phase 3 head-to-head against another incretin, Lilly's retatrutide more than doubled Ozempic's weight loss in type 2 diabetes, at the cost of roughly triple the discontinuation rate on the top dose.
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Its $1.275 billion upfront commitment to a Phase 1 program puts the spotlight on oral peptide developers, including Entera as it approaches Phase 3 in osteoporosis.
Bepirovirsen is the first therapy to offer people with chronic hepatitis B a shot at functional cure after a six-month course. It works in about one in five, and only in a narrow, already-treated population.
An oversubscribed EUR 120M Series D sends an off-the-shelf cancer vaccine toward a prevention trial measured in colonoscopy results from dozens, not thousands, of patients.
In depth
The FDA has accepted the first publicly announced biosimilar filing for Keytruda, built with no comparative Phase 3 trial. The pathway shortcut, not the molecule, is what reshapes the $31.7 billion franchise.
Read the storyFDA cleared Motivista as the first authorized treatment for negative symptoms of schizophrenia, but the pivotal trial showed a small-to-moderate effect against a control arm that also improved. The open question is whether payers will cover an app.
CSL is paying $355 million upfront for an antibody whose best evidence is a 26-patient interim readout. The deal prices claudin-1 biology, not proven data, across kidney and liver fibrosis.
The FDA granted accelerated approval to AstraZeneca’s camizestrant based on ctDNA resistance signals before radiographic progression, overruling a 6-3 advisory committee vote and betting on a new oncology paradigm.
Conjugating antisense oligonucleotides to transferrin receptor transport vehicles achieves fifty-fold deeper brain penetration, challenging the standard of invasive spinal punctures.
