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With inspections always on the table, LOTTE Biologics is pushing a proactive, quality first culture across its dual hubs in Syracuse and Songdo, backing its new single‑use ADC facility with rigorous training, self‑audits and real‑time regulatory surveillance.
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Speaking on the sidelines of the J.P. Morgan Healthcare Conference, Novo business development executive Tamara Darsow said the company is gunning for obesity and diabetes assets.
It doesn’t matter how many times you have traversed Union Square; no one knows which way is north, or where The Westin is in relation to the Ritz Carlton. A Verizon outage brought that into focus on Wednesday.
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.
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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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Backed by ARCH Venture Partners, F-Prime Capital and Mubadala Capital, the new company will develop a pipeline of brain-penetrant small molecules to address inflammation, metabolic dysfunction and restoring lysosomal function.
In a deal expected to close in Q1 2025, Roche will gain access to Poseida’s off-the-shelf CAR T candidates.
By mid-2025, the biotech will split into two entities: a new, as-yet-unnamed innovative medicines specialist and a cell therapy company, the latter of which will inherit the Galapagos name.
The FDA recommended maintaining a minimum of 5% weight-loss for drug developers seeking to establish the efficacy of their investigational obesity candidates.
Maze’s IPO comes on the heels of its oversubscribed Series D funding round, which infused the biotech with $115 million in funding to support the development of its kidney disease pipeline.
A post-marketing review by the FDA detected an increased risk of the autoimmune condition in patients inoculated with GSK’s Arexvy and Pfizer’s Abrysvo, prompting the regulator to require adjustments to the vaccines’ labels.
The investment continues a Novo dealmaking spree to cement its leadership status in the cardiometabolic space, with partnerships with Photys Therapeutics, Ascendis Pharma and two Flagship-backed start-ups.
BioSpace presents 25 noteworthy biopharma startups in ’25; analysts forecast stronger M&A as the J.P. Morgan Healthcare Conference kicks off next week; GLP-1s continue to expand their reach as Novo, Lilly fight against compounders; and a look ahead to five key FDA decisions in Q1.
Licensing deals have risen in prominence in a restrained market environment. Is it desperation, or an important part of the biotech ecosystem? Experts weigh in.
Look for renewed investment driven by lower interest rates in the new year, and a continued focus on late-stage assets, oncology and reaping the benefits of AI.