We are pleased to announce that Digestive Care Inc. (DCI), a client of Target Heath since 1998, has completed it’s submission of a New Drug Application (NDA) for PANCRECARB (pancrelipase), used in the treatment of Exocrine Pancreatic Insufficiency (EPI). The FDA had previously granted the product Fast Track designation and approved a rolling NDA submission schedule. For over a decade, DCI has provided products used to improve the nutritional status of patients living with chronic diseases, such as cystic fibrosis. According to our good friend and colleague, Dr. Tibor Sipos, President of DCI, “PANCRECARB is a unique bicarbonate buffered enteric-coated formulation of pancrelipase that has been an essential component of the armamentarium for the treatment of EPI associated with cystic fibrosis (CF) and other diseases affecting the pancreas. We are dedicated to continuing to provide PANCRECARB to CF patients and others suffering from EPI.

In addition to the NDA submitted by DCI, this year, Target Health was directly involved with Ferring Pharmaceuticals’ NDA and MAA submission for Degarelix for the treatment of prostate cancer and an MAA submission in the area of women’s health. Last year Target Health was directly involved with an approved BLA (Regeneron), and an approvable PMA and NDA.

For more information about Target Health or any of its software tools for clinical research, please contact Dr. Jules T. Mitchel or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors.

A new study has analyzed the effect of urinary frequency on the risk of bladder cancer. The research, which is published in the latest number of the International Journal of Cancer, shows a direct association between the number of times people get up at night to urinate and protection against bladder cancer. Night-time is usually the period during which there is the longest time interval between 1) ___. For this reason the length of time 2) ___ agents, such as those from tobacco for example, are present in the urine, constitutes an important factor towards the likelihood of developing bladder cancer, explains Juan Alguacil, a researcher from the University of Huelva and one of the authors of the study. The research group, made up of Spanish and North American scientists, analyzed the urinary frequency in 884 recently diagnosed bladder cancer cases and in 996 non-cancer control patients, from five regions in Spain. The patients, aged between 21 and 80 years, came from 18 hospitals in Valls, Barcelona, Asturias, Alicante and Tenerife. Although the best advice is to avoid exposure to carcinogenic agents (e.g. to stop smoking and to avoid direct contact with chemical products or pollution particles), the risk of bladder cancer could be 3) ___ by increasing urinary frequency and drinking water. The results of the analysis indicate that those people who usually get up at night at least twice to pass urine reduced their risk of suffering from bladder cancer by 40-59%. This protective effect was found in both men and women and did not relate to the consumption of tobacco or the quantity of water they drank. This was an exhaustive 4) ___ study undertaken to date about the effect of urinary frequency in bladder cancer. Throughout the world there are 357,000 new cases of bladder cancer every year with 145,000 deaths. The incidence of this 5) ___, one of the highest in the world, is rising mainly due to a greater life expectancy for the population and to the increasing incidence among women. According to the authors, to an extraordinary degree, the consumption of tobacco is leading to an increase of the incidence of this disease among 6) ___, which until now has been infrequent. In fact, it is estimated that in the near future the incidence of bladder cancer will be equal in both genders, owing to the increase in the number of women who smoke. It is estimated that between 50 and 70% of smokers will end up developing a bladder cancer, the main warning sign of which is the appearance of blood in the urine.
ANSWERS: 1) urination; 2) carcinogenic; 3) reduced; 4) international; 5) tumor; 6) women