Accelerating biosimilar market access: the case for allowing earlier standing.

Biosimilars, which are affordable alternatives to biologic medicines, face delays in market entry due to the current patent litigation framework under the Biologic Price Competition and Innovation Act. Currently, biosimilar manufacturers can only initiate patent litigation to attempt to clear weak and invalid patents after submitting their Biologic License Application to the Food and Drug Administration (FDA), which happens after completing extensive, and costly clinical trials. By contrast, generic drug manufacturers can start litigation earlier due to shorter development times and less stringent clinical requirements, allowing them to launch immediately after the primary patent expires.

Loss of Mist1 alters the characteristics of Paneth cells and impacts the function of intestinal stem cells in physiological conditions and after radiation injury.

Intestinal stem cells (ISCs) and Paneth cells (PCs) reside at the bottom of the crypts of Lieberkühn in the small intestine. Recent studies have shown that the transcription factor Mist1, also named BHLHA15, plays an important role in the maturation of PCs. Since there is an intimate interaction between PCs and ISCs, we speculated that the loss of Mist1 could impact these two neighboring cell types.

Identifying an effective Chinese herbal medicine for reducing postoperative hidden bleeding and stabilizing blood volume following intertrochanteric femur fracture: a Bayesian network meta-analysis of randomized controlled trials.

Objective: Chinese herbal medicine (CHM) is extensively utilized in managing hidden bleeding following an intertrochanteric femur fracture (IFF). Despite its widespread use, the most effective CHM approach for addressing hidden bleeding post-IFF remains unclear. A Bayesian network meta-analysis was conducted to identify a CHM that both effectively reduces hidden bleeding and stabilizes blood volume after IFF.

Acute metabolic decompensation after liver transplant in a patient with maple syrup urine disease.

Maple syrup urine disease (MSUD) is an inborn error of metabolism characterized by the accumulation of branched-chain amino acids (leucine, isoleucine, and valine) caused by a defect in the branched-chain alpha-keto acid dehydrogenase complex. Liver transplant is an effective therapy for MSUD, and patients can usually tolerate a regular diet after transplant without symptomatic metabolic decompensation. Most post-transplant patients do not follow a sick-day diet.