Techniques that bypass or trick the guardian of the central nervous system. Developing drugs that can penetrate into the brain requires some creativity. The approaches vary, each technique comes with its benefits and drawbacks, making it appropriate for some patients or drug types but not others. In some diseases, you might want the drug everywhere; […]
Preliminary data suggest that survivors of SARS-CoV-2 infection may be susceptible to reinfection within weeks or months. One study in ~1,500 COVID patients show that 10 percent % of these patients had undetectable antibody levels within weeks of first symptoms or lost their antibodies two to three months after recovering from the infection. Early works […]
Lesions in the lungs of patients with pneumonia caused by a SARS-CoV-2 infection are distinct from those caused by bacteria. SARS-CoV-2 is known to damage lung tissue as many COVID-19 patients develop pneumonia, which can progress to respiratory failure and sometimes death. In chest CT scans lungs of COVID-19 patients show cloudy lesion patterns that […]
People tend to believe that a repurposed therapy can never be truly novel or transformative. Nothing could be further from the truth. One attractive option of Drug Repurposing is to use a scientific approach to identify new uses for existing drugs. About a third of orphan approvals by the FDA since the program began have […]
BBCR’s team has experience in biologics for rare diseases including rare cancers and precision medicine and can help develop a targeted strategy including studies with fewer patients to control safety issues. Services include: Indications analysis and prioritization Strategic drug assessment Clinical study design and protocol Biomarker strategy Early Clinical Development FDA meeting and submission Pre-ND […]
BBCR Consulting offers world-class regulatory, clinical research, and biomarker consulting services that provide high-value, and support our clients’ operational and functional needs. Our process is designed to maximize time efficiencies, risk mitigation, and cost savings. We partner with domestic and international, small-to-medium drug and device companies that are entering early clinical development. BBCR is dedicated […]
Biotech companies’ continued participation in the Global Orphan Drug Market Opportunity requires the development of new strategies rooted in the established knowledge of orphan developer experts. Participation of big pharmaceutical companies in the ongoing clinical research of orphan drug are about to introduce a drastic change in overall scenario of the approach. Global Orphan Drug […]
At least 28 communities living in extreme isolation in the Brazilian Amazon, and there may be as many as 80 more, have confirmed to be in existence. On April 9, a Yanomami adolescent had died of COVID-19 in the northern state of Roraima. The youth had moved back and forth through an area rife with […]
A pilot study in China in which seven COVID-19 patients received intravenous infusions of donor mesenchymal stem cells (MSC) indicates that the intervention was safe, and that the approach may improve infection outcomes was reported in Aging and Disease last month. We understand that it is only a small number of cases, and studies in […]
Saliva Test for COVID-19 Approved for Emergency Use by FDA on 13 April 2020. Saliva testing will help with the global shortage of swabs, increase possibility of people testing, and reduce risk to collect samples by health care professionals. The saliva-based test requires saliva collection by subject spitting several times in a given plastic tube. […]