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The United States Pharmacopeia (USP) is proposing a new approach for its work to support the quality and availability of selected biologic medicines. Building on decades of experie...
This report is intended to inform discussion and decision making, not to prescribe solutions. Produced in collaboration with GEN, it reflects the collective voice of an industry ad...
Duracyte’s implants employ cells engineered to produce therapeutic protein, bypassing the complexities of traditional biologics manufacturing. The startup’s marriage of biotechnolo...
The FDA has approved golimumab-sldi as the first interchangeable biosimilar to Simponi for ulcerative colitis.Golimumab-sldi (Immgolis, Accord BioPharma) has been approved as a bio...
The risk for major adverse cardiovascular events appeared similar between older patients treated with 5-aminosalicylic acid and those who received immunomodulators or biologics for...
An analysis of the 67 ex parte reexaminations used to challenge biologics patents over the last 13 years reveals that reexamination may emerge as an alternative to inter partes rev...
ProBio is building flexible platforms for multispecific antibodies, ADCs, and other advanced therapeutic approaches. The post From Discovery to Development in Emerging Modalities a...
The company, which emerged from stealth this week, is using the funds to develop and test three therapeutic assets that it licensed from external partners as well as to progress so...
FDA approval of Orca Bio’s Tregzi makes it the first cell therapy based on regulatory T cells, or Tregs. Clinical trial results showed reduced risk of graft-versus-host disease, a...
Licencing agreement grants Ipca access to Bhami Research’s proprietary high-concentration subcutaneous biologics delivery platform for the development and commercialisation of mult...
Biogen has struck a backloaded, $1 billion deal to buy RayThera, snagging a pipeline of anti-inflammatory drug candidates led by a prospect on the cusp of clinical development.
Samsung Bioepis announced Wednesday the launch of its Ustekinumab biosimilar in Japan, marking the company’s first product debut in the country under a partnership with NIPRO Corp....
In a quest to provide more relevant translational data, traditional in vivo models join forces with new approach methodologies. The post Next Generation Biopharma Innovation appear...
The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues.
Mammalian cell-based biopharmaceutical manufacturing systems are complex, expensive, and, say the authors of a new study, not suited to producing medicines in resource-constrained...
Intensified strategies are reshaping biologics manufacturing by boosting speed, flexibility, and productivity without expanding facilities or footprints. The post Bioprocessing at...
Biopharma development has long trended toward specialized and personalized therapies such as cell and gene therapies, antibody-drug conjugates, and monoclonal antibodies (mAbs), am...
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