Currently, there are two approved drugs to treat ALS: Riluzole, which can extend lifespan by an average of a few months and has been on the market for 25 years Edaravone, approved in 2017, which in clinical trials showed to help patients function for longer into their disease. Unfortunately, ALS is still a deadly disease […]
Last June 16, researchers announced that they’d seen an improvement in survival at 28 days after entry into the a large, randomized controlled trial for COVID-19 trial for the sickest patients who received the drug dexamethasone. These results, outcomes of 2,104 patients who received dexamethasone, are a logical solution to the immune system overreaction that […]
The IND requires very detailed product and development data such as information related to manufacturing, data from nonclinical studies, and previous clinical studies related to the IMP. IND also requires a comprehensive source of documentation including study reports. It follows the CTD structure developed by ICH and is mandatory to be submitted in the eCTD […]
Pediatric Rare diseases and Rare Pediatric Disease Designation FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the criteria specified. Section 529 of the FD&C Act is intended to encourage development of new drug and biological products for the prevention and treatment of rare pediatric diseases. Section […]
The World Orphan Drug Congress USA will be a live virtual conference. BBCR’s Team invites you to send an email at [email protected]/bbcr2. We hope to meet many of you that will attend the World Orphan Drug Congress. We are very much interested in learning about your programs to determine if BBCR’s expertise in Rare Diseases […]
Scientists launched studies in search of genes that could explain why some people infected with SARS-CoV-2 get really sick, while others have only mild symptoms. We know that chronic health conditions—such as hypertension and diabetes can play a role, but there are also evidences that people’s genes can influence how their bodies react to other […]
Given the global Covid19 emergency and the global nature of the pharmaceutical and biotech industry, key operational areas will be impacted. As with any emergency response, the key to management is implementing mitigation plans. Early stage pharmaceutical and biotech companies need to be proactive in developing contingency plans to jump start clinical research after Covid19. […]
Confirmed cases reported from each country so far. Data from cruise ship outbreaks not included. SOURCE: ECDC
The gut microbiome serves many useful functions in the body, but it can also rev up the immune system in harmful ways. Zit has been pustulated that Diet can influence the microbiome and the mucosal immune response. In the paper: “Diet modulates colonic T cell responses by regulating the expression of a Bacteroides thetaiotaomicron antigen,” Sci Immunol, 4:eaau9079, […]
Today, it is widely accepted that NETs have both a protective and a pathological impact on the host. When neutrophils encounter pathogens, not only engage in phagocytosis and degranulation, they also release neutrophil extracellular traps (NETs) In CANCER, NET-associated proteins lead to reawakening of dormant cancer cells and convert them to proliferating metastatic cells. In […]