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Target action dates for drugs sponsored by Sanofi, Boehringer Ingelheim and Disc Medicine have also been pushed back despite assurances of swift reviews under the FDA’s new Commissioner’s National Priority Voucher program.
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Primarily known as an immunology and neuroscience company, AbbVie wanted to put the biopharma world on notice during its J.P. Morgan presentation: its oncology portfolio is underappreciated. This week, the Illinois-based company dove into the sizzling PD-1/VEGF space with a licensing deal with China-based RemeGen.
Buying vaccine biotech Dynavax was an easy choice for Sanofi despite antivaccine moves by the Trump administration.
At a J.P. Morgan media event Tuesday, the Gilead C-suite seemed to be walking on air as they highlighted Yeztugo’s capture of the HIV market and its plans for business development.
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With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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In the third podcast in a special series focused on BioSpace’s NextGen Class of 2025, Senior Editor Annalee Armstrong speaks with Mark McKenna, CEO of Mirador Therapeutics.
Under the terms of the agreement, OPKO will accept 60% of the development costs, while Entera will shoulder 40%.
Monday was a busy day for AstraZeneca, which also paid up to $1 billion to acquire Belgian biotech EsoBiotec and its cell therapy pipeline and technology.
The gene therapy world is in turmoil, but Arbor, armed with more than $1 billion in partnerships and raises, is going forward.
Japan-based Taiho Pharmaceutical has worked with Araris Biotech since 2023 developing antibody-drug conjugates for the oncology space.
AstraZeneca has recently been investing heavily in the cell therapy space, including two acquisitions for TeneoTwo and Gracell Biotechnologies.
The appeals court for the Federal Circuit upheld a lower court’s ruling, finding that Regeneron has not sufficiently established that Amgen’s biosimilar Pavblu violates key patents of Eylea.
The company unveiled plans last week to test its GLP-1/glucagon dual receptor agonist in alcohol use disorder and alcohol-related liver disease.
Dyne is eyeing an accelerated approval filing for DYNE-251 in early 2026 that would pit the asset against Sarepta’s Exondys 51 in a patient population amenable to exon 51 skipping.
As obesity drug developers compete for the highest weight-loss efficacy, experts contend that overall health outcomes—evidenced by successful studies in therapeutic areas like cardiovascular and sleep apnea—may prove a greater market advantage.