News & Articles

An overview of the key regulatory intelligence updates from FDA, EC, EMA & MHRA released in 2024.

The evolution of the regulatory landscape for biopharmaceutical and advanced therapy companies demands a focus on aligning innovative technologies, such as platform methods and advanced manufacturing, with the expectations of regulatory agencies.

Pulmonary drug delivery has been primarily the delivery of choice for the treatment of local conditions or diseases active in the respiratory tract for over 70 years. For local activities, inhaled drugs are delivered directly to the site of action in the lung, providing fast onset of action.

Therapeutic vaccines differ from traditional prophylactic vaccines in that they are not targeted to a foreign antigen/protein but instead are intended to modulate the host immune system to endogenously present antigens and are routinely administered after an infection, cancer or other chronic disease state is established.

Scendea is proud to announce our partnership with CUES Consulting, specialists in Japanese regulatory affairs, safety management, and post-marketing surveillance.

An FDA 483, also known as a “Form FDA 483” is a document issued by the U.S. Food and Drug Administration (FDA) to a company at the conclusion of an inspection, when the FDA investigator has observed any conditions that in their judgement may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and related Acts. 

Developing a novel drug, including discovery, nonclinical toxicology studies, and clinical studies, may take many years. Once a Company has generated this comprehensive body of data, the final step prior to regulatory approval is Health Authority review of the marketing authorisation application. 

The rare pediatric disease priority review voucher (RPD PRV) program was introduced by the US Food and Drug Administration (FDA) in 2012 with the aim of incentivizing drug development for new medicines targeting rare pediatric diseases.

In the evolving landscape of clinical research and regulatory frameworks, Regulation 536/2014, also referred to here as the Clinical Trials Regulation (CTR), marks a significant milestone set to transform the conduct and oversight of clinical trials.

With demand for improved healthcare increasing globally, Australia is continuing to emerge as an attractive destination for the development of new and improved drugs and medical devices, driven by excellent research capabilities, a favourable Therapeutic Goods Administration (TGA) regime and an attractive Research and Development Tax Incentive (RDTI) regime.

Scendea Ltd is proud to announce it has received a King’s Award for Enterprise for International Trade 2024. This prestigious award recognises Scendea’s outstanding growth in international trade.

In the European Union (EU) a network of approximately 50 regulatory authorities from the 30 European Economic Area (EEA) countries1, the European Commission (EC) and European Medicines Agency (EMA) form the basis of the European regulatory system and play a role in the authorisation and monitoring of medicines in this region.

Sponsors of investigational medicinal products (IMP) are encouraged to seek guidance from the FDA throughout the course of development in order to maximise the likelihood of regulatory approval. The FDA offers opportunities for Sponsors to request guidance on a development program free of charge and irrespective of the stage of development.

Oncolytic viruses (OVs) have gained significant attention and interest in the last two decades for their unique ability to selectively infect and replicate within cancer cells. The concept of oncolytic virotherapy involves using viruses to target and destroy cancer cells while sparing normal, healthy cells. OVs not only directly destroy tumor cells but also stimulate the host’s anti-tumor immune system response, which destroy neighbouring cancer cells.

The development of a new drug is a lengthy and expensive process. On average it takes 10-15 years, with an estimated cost of £1-2 billion for a potential drug to be approved for use. Analysis of clinical trial data from 2010 to 2017 show that 30% of compounds that reach Phase I clinical trials fail due to unmanageable toxicity, and many of those fail due to nephrotoxicity and acute kidney injuries.

The pathway for transitioning into a clinical-stage company is a crucial step in the development lifecycle of a product, as a favorable safety profile needs to be demonstrated and regulatory approval received before embarking on first in human clinical studies.

Patient safety is at the centre of drug development and monitoring the safety profile of a drug from the first patient dose through to market and beyond is a key activity for all drug developers.

The first regulation and guidance for copy biotech products (biosimilars), pioneered by the EMA, not only enabled the introduction of biosimilars in the EU, but also were a model for regulatory regions worldwide.

An overview of the key regulatory intelligence updates from FDA, EC, EMA & MHRA released in 2023.

The first regulation and guidance for similar biological medicinal products (‘biosimilars’) was introduced by the European Union, as it was considered impossible to make exact copies of biopharmaceuticals.