Biotech companies, who are looking to secure investment to enable development of their medicinal products, must navigate a competitive funding landscape while optimizing their fundraising strategies. To de-risk and support fundraising strategies globally it’s imperative that product development and regulatory strategy are carefully considered and enacted upon.

In August 2024, the US Food and Drug Administration (FDA) released new guidance for the Project Optimus initiative, titled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases”.

Antimicrobial resistance (AMR) poses such a
significant threat to global public health that it now necessitates urgent action to accelerate the development of new antibiotics. Currently, most research into new antimicrobials is conducted by academia and start-up companies. Whilst the focus appears to remain on traditional small molecule therapeutics, novel approaches have gained attention across biologics, bacteriophages, and microbiome projects.

In April 2025, the US Food and Drug Administration (FDA) announced their plan to phase out animal testing and instead favour more effective, human-relevant methods – namely “New Approach Methodologies” (NAMs).

Before entering clinical trials in humans, new drugs and devices must undergo nonclinical testing to evaluate their safety and efficacy. There is no fixed roadmap for nonclinical studies required for such assessments – regulatory authorities assess applications in a case-by-case manner – however, traditional approaches are outlined in FDA, EMA and ICH guidance documents.

The drug discovery and development process that takes a chemical compound from initial lead selection to preclinical evaluation and ultimately the clinic is not necessarily a
linear one. 

Discover why Australia is a leading destination for clinical trials. In this webinar, Scendea and our partners explore the key advantages, including expedited regulatory approvals, cost efficiencies, and access to top-tier facilities and expertise.

The FDA accelerated approval pathway was established in 1992 (FDA, 1992) to expedite access to new therapies for patients with serious or life-threatening diseases. First created to rapidly address unmet medical need during the HIV-AIDS crisis, oncology drugs now comprise the largest proportion of accelerated approvals (Sachs et al., 2021).

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.