In 2020, the COVID-19 pandemic had a significant impact on many areas of society. However, drug approvals in the pharma industry was not adversely impacted, and despite staffing issues the FDA was able to approve 121 novel drugs in 2020 compared with 119 in 2019.  This was inclusive of an increase in approvals of new molecular entities (NMEs) which is the most innovative drug type and this number does not count emergency use authorizations for COVID-19 vaccines. Pharma Industry Newly Approves Gene and Cell Therapies The pharma industry has newly approved gene and cell therapies that expanded the use of technology to

The COVID-19 pandemic’s impacts were numerous and far-reaching, creating disruptions across the world. However, new pharmaceutical product launches continued, leading to the development of vaccines and many other products. How have Clinical Trials Been Impacted by the Pandemic? Clinical trials have faced a lot of disruption since the beginning of the pandemic, however, activity levels have remained extremely high. The commencement of clinical trials increased by 8% with the advent of remote, virtual or decentralized trials helping to maintain the numbers. Clinical trials in some areas did decrease, however this is likely to have been due to a rearrangement of priorities in

Biological products, also known as biologics, have formed a cornerstone of modern healthcare for decades. Blood transfusions, gene therapy, monoclonal antibody treatment, vaccinations, and many more key clinical processes rely on goods derived from living organisms rather than chemical synthesis. Unfortunately, the development and manufacture of biologics can be extremely expensive. A common topic of debate by key opinion leaders in recent years has been the emergence of biosimilars and how to accelerate clinical trials in biosimilar development programs. What are Biosimilars? Biosimilars aim to reduce the costs associated with biologically-derived treatments without inhibiting the clinical significance of the innovator product. The goal is to identify

The Medicines and Healthcare Products Regulatory Agency (MHRA) has released its 2020-21 business plan, outlining its primary goals for the coming year. Driven by the need to develop new regulatory models and improving patient access to cutting-edge drugs and medical devices, the plan concerns various aspects of the British life sciences industry, including the efficacy and efficiency of clinical trial supplies. In the executive summary, the plan sets out the primary aim of “driving forward a substantial strategic and cultural change through 2020-21”. Though the document discusses a range of granular challenges in healthcare and medicine, two of the biggest issues covered are the