Biological medicinal products cover a diverse field. In the European Union, many of these are under the responsibility of the European Medicines Agency and are authorised via the centralised marketing authorisation procedure, such as products manufactured by biotechnology, or advanced therapy medicinal products. Naturally derived biological maybe nationally authorised in individual Member States, rather than through the pan European procedure. Due to the diverse nature of biological products, a number of specialised groups have been established within the Agency to supervise and coordinate activities related to these products. The regulation of follow-on biologics is a rising concern for the biotech industry since many biologics are approaching the end of their patent life, and as a result, will open the market for more affordable generics.
Oral Squamous Cell Carcinoma (OSCC) also termed epidermoid carcinoma, is a malignant neoplasm that is derived from or exhibits the morphologic features of oral squamous epithelium. In India, the prevalence of oral cancer is up to four times higher than in other countries. It is most common cancer and approximately 94 percent of all oral malignancies are squamous cell carcinoma. The higher incidence of cases is linked to the high prevalence of a unique smokeless tobacco habit in which the tobacco, typically mixed with areca (betel) nut, slaked lime and spices, known as quid or paan and is held in the buccal vestibule for long period. This combination is more carcinogenic than tobacco used alone. Loss of heterozygosity (LOH) of chromosome region 17p and mutation of the TP53 gene are genetic alterations that occur in the stages of progression from dysplasia to invasive squamous carcinoma. Alterations of TP53, including mutation or deletion, are associated with increased genomic instability in oral dysplasia and may accelerate the rate of genetic alterations in oral carcinogenesis.
Natural and synthetic optically active butyrolactones have attracted much attention due to their biological and functional properties. These molecules play key roles as building blocks for the synthesis of many types of natural products and potential drugs. Hibiscus acid is one of the natural optical isomer of hydroxycitric acid belongs to butyrolactone category. Hibiscus acid is known to be a potent inhibitor of ?-amylase and ?-glucosidase, which results into the reduction in absorption and metabolism of carbohydrate and therefore it might be hypothesized that hibiscus acid could inhibit lipogenesis during a lipogenic diet i.e. a diet rich in carbohydrates. This review focussed on exploring the journey of hibiscus acid since its discovery in 1939. Findings of the last seventy years are detailed within the context of its source, discovery and different methods of isolation, chemistry, total synthesis, stereochemistry, properties and derivatives of hibiscus acid, spectroscopic data and biological applications. This commentary is a coherent presentation of scattered literature on hibiscus acid and is provocative of further research.