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UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
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While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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Eli Lilly inked two collaborations on Monday, one focused on cardiometabolic diseases with South Korea’s OliX Pharmaceuticals and another for cancer therapies with Australia’s AdvanCell.
Vertex expects to make the newly approved non-opioid pain medicine Journavx available by the end of February.
Nerandomilast, an oral phosphodiesterase 4B inhibitor, hit the primary endpoint in a Phase III trial in progressive pulmonary fibrosis—nearly six months after achieving a similar feat in idiopathic pulmonary fibrosis. Boehringer plans to submit for FDA and other global approvals in both indications.
The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in partnership with Pfizer. AbbVie acquired its share of the asset as part of its $63 billion buyout of Allergan.
Adding a new indication for the CAR T cell therapy could help BMS offset the loss-of-exclusivity headwinds it faces in the coming years.
The carve-out acquisition will allow Bain to capitalize on the “promising signs for growth” in the Japanese life sciences market, recently revitalized by more industry-friendly policy changes from the government.
It is unclear why an independent data safety monitoring board recommended the suspension of Pliant’s Phase IIb/III BEACON-IPF study in idiopathic pulmonary fibrosis.
AceLink is advancing a small-molecule treatment option for Fabry disease that could provide a more convenient alternative to the current enzyme replacement therapy standard.
Novo Nordisk’s bispecific antibody Mim8 prevented bleeding events and caused no adverse safety events in the Phase III FRONTIER3 trial. The company plans to file for approval this year, hoping to compete in the hemophilia A space with Roche’s blockbuster Hemlibra.
If the attention generated by BioSpace’s coverage of this landmark approval is any indication, Americans are hungry for non-opioid pain treatments that could help quell the still raging opioid epidemic.