The US FDA’s waiving of an advisory committee is another promising signal that Sarepta's Duchenne gene therapy SRP-9001 could be approved on 29 May and set it up to become a bigger earner than Novartis’s Zolgensma.
Sarepta’s chances of gaining approval for the first ever Duchenne muscular dystrophy gene therapy and setting a new benchmark in the market look stronger following a decision by the US regulator not to hold an advisory committee to inform its review of the company's SRP-9001.
That means there are no extra hurdles for SRP-9001 (delandistrogene moxeparvovec) to clear before an expected US Food and Drug...
The Swiss pharma company is rebalancing the portfolio, emphasizing best-in-class drugs and moving into new areas like cardiovascular and metabolic disease.
In this week's episode: Trump’s UK drug pricing win; Novo explains semaglutide Alzheimer's rationale; J&J and Novartis on this year’s biggest M&A deals; a look at the mixed performance of CAR-Ts; and Akeso’s goals beyond ivonescimab.
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
Lilly's first Phase III triplet win opens the door to a label expansion in BTK-pretreated CLL, with analysts suggesting Jaypica could attain blockbuster status. However, the window to capitalize may be brief as next-generation BTK degraders close in with head-to-head trials.
![Spotlight On RDCs, AOCs As Leading Novel Bioconjugates[Updated]](https://web.insights.norstella-labs.com/resizer/v2/3M7ZAWZOBNK7NG4A4WDOIFG6DU.jpg?smart=true&auth=392a1fdb3cfacb29445720c412410e598dbcc5f90f14857652cd498bd0faa0fb&width=400&height=225)
