After a Phase III blow-up in February, Peregrine Pharmaceuticals Inc. has finally decided what to do with its flailing immuno-oncology program, all while trying to put the focus on its more successful contract manufacturing business.
Peregrine Officially End Late-Stage Development of Bavituximab
The biotech continues to look for alternative data that could resurrect its lead product after a slew of failures.
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Plus deals involving J&J/Addex/Sinntaxis, Concentra/Kronos, Granata/Oviva, Coeptis/Z Squared, Ligand/Channel and more.
The company plans to expand manufacturing of the HER2-targeting ADC beyond China and plans to file for US FDA approval in 2025.
PTC said its updated Phase II data for PTC 518 met the primary endpoint of Huntingtin’s protein reduction, but analysts said there isn’t clear correlation with clinical benefit.
Restructuring Edition: Unity unveiled more Phase IIb data for lead asset UBX1325 along with plans to shed its workforce while seeking a partner for it and other drugs. Also, Ono is consolidating US employees at one site, Entrada is cutting its workforce by 20% and other recent strategic shifts.
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Genmab will submit an sBLA for Epkinly in R/R follicular lymphoma in H1 2025, backed by positive Phase III data.
Drugmakers aren’t expecting a big financial hit from tariffs for now, but a report commissioned by PhRMA suggests the cost of pharma-sector tariffs could be steep.
Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.