Finding that a lower court went too far with an injunction that ignores the Hatch-Waxman safe harbor protections for drug development, the U.S. Court of Appeals for the Federal Circuit handed Avadel CNS Pharmaceuticals LLC a win of sorts.
As biopharma companies continue to roll out their first-quarter earnings, Trump administration tariffs remain at the top of investors’ minds. While executives offer their various strategies to appease concerns, the uncertainty prevails, making it difficult to clearly satisfy all of the questions.
The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd.
Private biotechs in Switzerland raised CHF833 million (US$1.002 billion) in 2024, driving an overall increase in capital investment in the sector to $3 billion, up from $2.4 billion in 2023.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adcentrx, Denali, Johnson & Johnson, Omeros, PRM, Urogen.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Apotex, Beigene, Biovaxys, Boehringer Ingelheim, C4, Formosa, Ironwood, Neurocrine, Sona, Viverita, Voyager.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Altesa, Astrazeneca, Beacon, Crispr, Daewon, Daiichi Sankyo, Dr. Falk, Gilead, Ipsen, Marea, Perfuse, Phio, Theriva, Tiumbio, Vertex.
Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.
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