Decentralized clinical trials (DCTs) are an innovative approach to conducting clinical research, where some or all trial-related activities occur at locations other than traditional clinical trial sites. These locations can include participants’ homes, local healthcare facilities, or nearby laboratories. Key Features of DCTs: Benefits of DCT: DCTs are gaining momentum, especially after the COVID-19 pandemic highlighted […] The post What is Decentralized clinical trials?:Benefits and challenges of implementing DCT appeared first on LifeProNow ..read more

March 06, 2024: “The U.S. Food and Drug Administration is taking several additional steps to address concerns about elevated lead levels in cinnamon following the recent incident associated with certain cinnamon apple sauce pouches that resulted in lead poisoning in young children. The agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the U.S., reminding them of the requirement to implement controls to prevent contamination from potential chemical hazards in food, including ground cinnamon products. The agency is also recommending ..read more

March 05, 2024: “The U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to a ..read more

February 28, 2024: “The U.S. Food and Drug Administration is announcing that grease-proofing materials containing per- and polyfluoroalkyl substances (PFAS) are no longer being sold for use in food packaging in the U.S. This means the major source of dietary exposure to PFAS from food packaging like fast-food wrappers, microwave popcorn bags, take-out paperboard containers and pet food bags is being eliminated.  PFAS are a diverse group of thousands of chemicals that resist grease, oil, water and heat. The FDA has authorized certain PFAS for limited use in cookware, fo ..read more

30 Jan 2024: “Bristol Myers Squibb announced three regulatory acceptances from the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) for Breyanzi® (lisocabtagene maraleucel). In the U.S., the FDA has accepted the company’s two supplemental Biologics License Applications (sBLA) for Breyanzito expand into new indications to include the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) and relapsed or refractory mantle cell lymphoma (MCL) after a Bruton tyrosine kinase inhibitor (BTKi). The FDA has ..read more

January 23,2024: “BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, announced that it has exercised its option to exclusively license OpCT-001, an induced pluripotent stem cell (iPSC) derived cell therapy candidate for the treatment of primary photoreceptor diseases, from FUJIFILM Cellular Dynamics and Opsis Therapeutics. OpCT-001 is the lead cell therapy candidate being developed under the strategic R&D collaboration between BlueRock, FUJIFILM Cellular Dynamics, and Opsis Therapeutics that was fo ..read more

January 08, 2024: “The U.S. Food and Drug Administration is announcing that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization. This update will facilitate broader adoption of VHP as a sterilization method for the medical device ..read more

December 20, 2023: “GSK plc and Hansoh Pharma, a Chinese biopharmaceutical company committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders” announced that they have entered into an exclusive license agreement for HS-20093, a B7-H3 targeted antibody-drug conjugate (ADC) utilising a clinically validated topoisomerase inhibitor (TOPOi) payload. Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress clinical development and commercialisation of HS-20093. H ..read more

December 14, 2023: “The U.S. District Court for the District of Massachusetts has entered a consent decree of permanent injunction ordering Pharmasol Corporation, a Massachusetts-based company, and President Marc L. Badia to stop distributing drugs until the company complies with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in the consent decree. According to the complaint, which was filed along with the consent decree by the U.S. Department of Justice, Pharmasol and Badia unlawfully distributed adulterated drugs, meaning they do not comply with manufacturi ..read more

Job interviews can be nerve-wracking, but one question that you can almost guarantee will come up is, “Why are you changing jobs?” While it may seem like a straightforward query, crafting a thoughtful and convincing response can significantly impact the outcome of your interview. In this blog post, we’ll explore how to answer this common interview question effectively. 1. Emphasize Career Growth and Learning Opportunities One of the most positive reasons for changing jobs is to seek new challenges and opportunities for professional development. When an interviewer asks about your reasons for c ..read more