The FDA's rejection of Sandoz Inc.'s version of Amgen's Neulasta (pegfilgrastim) has revealed the hard truth that chasing the biosimilar market may be a riskier and more costly endeavor than companies anticipated.
Sandoz Inc. has appeared to be on easy street with its US biosimilars – being the first company to enter the US market last year, while another of its applications last week breezed through an FDA advisory committee meeting.
But stark reality came knocking: Sandoz was hit with a complete response letter (CRL) for its version of Amgen...
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.
Mounjaro, Eliquis, and Darzalex buck the Q1 trend to make gains
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