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However, these efforts are haunted by a shortage of resources, restrictions on importing API, social distancing at facilities, disturbed supply chains, and tremendous pressure to quickly manufacture and distribute products. Despite these arduous circumstances, it remains critical for pharma companies to maintain quality and compliance and follow regulatory guidelines. Doing so requires pertinent measures to ensure adherence to Current Good Manufacturing Practice (CGMP) guidelines, and data integrity to meet the requirements of regulators including the U.S. Food and Drug Administration (FDA),

The pharmaceutical manufacturing process and critical quality attributes (CQAs) are not only needed to control tightly but also required to be protected from any vulnerability in real-time. Currently, pharmaceutical manufacturing companies are facing enormous challenges to protect their plant from possible cyberphysical security (CPS) threats. Cyber-physical security is essential not only to protect the plant from any mechanical damages but also to assure the product quality and thereby, patient safety. The quality of the pharmaceutical products can be improved significantly by implementing a

In August 2021, ransomware operators targeted the health department of the Italian region of Lazio and disabled its COVID-19 vaccination booking system, disrupting the scheduling of new vaccination appointments for days.

Since it contains the city of Rome and is one of Italy’s most densely populated areas, Lazio was an attractive target because of the strong desire among its people to get vaccinated and gain its Green Pass vaccine passport. Hackers likely believed that this would pressure the authorities to pay up the ransom to unlock the systems they had disabled through a cyberattack.

In the last few decades, hot-melt extrusion (HME) has emerged as a rapidly growing technology in the pharmaceutical industry, due to its various advantages over other fabrication routes for drug delivery systems. After the introduction of the ‘quality by design’ (QbD) approach by the Food and Drug Administration (FDA), many research studies have focused on implementing process analytical technology (PAT), including near-infrared (NIR), Raman, and UV–Vis, coupled with various machine learning algorithms, to monitor and control the HME process in real time. This review gives a comprehensive ove

In the treatment of pediatric diseases, mass-produced dosage forms are often not suitable for children. Commercially available medicines are commonly manipulated and mixed with food by caregivers at home, or extemporaneous medications are routinely compounded in the hospital pharmacies to treat hospitalized children. Despite considerable efforts by regulatory agencies, the pediatric population is still exposed to questionable and potentially harmful practices. When designing medicines for children, the ability to fine-tune the dosage while ensuring the safety of the ingredients is of paramoun

The principles of Humane Experimental Technique has resulted in 3Rs concept: Replacement, Reduction and Refinement of animal tests. The number of animals used for both preclinical and quality control is thought to be reduced to zero if vaccines are better characterised while allowing testings by a set of in vitro methods rather than in vivo scenarios. The in vitro methods to detect safety related to potency of vaccines can employ alternative platforms like that of human derived cell/tissue based surrogate systems - The humane technique facilitating increased control of critical stepsin produc

The biopharmaceutical industry operates under strict regulations, and effective supply chain management is crucial for patient safety and timely access to treatments. The biopharmaceutical supply chain is responsible for ensuring efficient and secure delivery of drugs and vaccines while maintaining product quality. Challenges such as compliance, risk management, and technology adoption have emerged in recent years. Cold chain management, monitoring technologies, and new regulations like DSCSA and FMD have impacted the industry. Adhering to trends and regulations, including blockchain and arti

Pharma 4.0, an application of Industry 4.0 concepts in the pharmaceutical industry, aims to enhance manufacturing efficiency, product quality, and consistency. It faces challenges in areas like artificial intelligence, material traceability, optimization, process control, cyber-physical security, and data management due to the complexity involved. However, by incorporating artificial intelligence and advanced model predictive control with robust cyber-physical security measures, predictive capabilities and product quality can be significantly improved. This work focuses on implementing seven

Globally, the outsourcing of services for drug development and commercialisation is increasing. Regulatory services are often included in this, and regulatory activities are increasingly the subject of specific, dedicated FSP (functional services partnership) projects. This article overviews a number of the more common models, including cost models, that can be deployed for the outsourcing of regulatory services. We assessed the appropriate criteria and advantages of these models, illustrating with examples from our experience. Interestingly, over the life of a single project, different model

The Global Biosimilars Market is estimated to reach US$240 billion by 2030, with the Indian market at US$35 billion. The considerable increase in reference products, with the USFDA adding 90 molecules and India approving 70 biosimilars, promises to usher in further growth. The Biopharma industry seems keen on investing in the biosimilar market with a focus on improving healthcare and health care costs for diseases of interest like COVID-19, cancer, immunologic diseases, and diabetes. This is evident in the projected growth of the oncology biosimilar market at 17 per cent CAGR, and the growing

It’s been nearly two years since the outbreak of COVID-19 began and we’re still in the midst of enormous disruptions to the world’s economies, businesses, education, and people’s lives. The pharmaceutical industry has been particularly disrupted. Previously, pharma companies suffered from a bad reputation. But following the emergence of the pandemic, they were thrown into the spotlight, suddenly having an important voice on the health of the world. Leaders in the pharma space were on the front cover of every newspaper and magazine not because of scandal, but because of the lifesaving treatmen

The life sciences sector has become increasingly popular given the ongoing global health crisis, putting the spotlight firmly on the need for greater medical care and infrastructure. Implementation of tech solutions to improve existing health infrastructure has also become a trend and one likely to continue as current health and economic challenges due to COVID-19 will see digital health companies playing a more important role in corporate and national growthThe life sciences sector continues to see a multitude of deals involving complex deal structures, from special purpose acquisition compa

This article explores the intricate relationship between Big Pharma and healthcare policies in the United States, unraveling the historical context, lobbying tactics, and policy impact. It delves into specific examples, such as the opioid crisis, and examines reform efforts amid public backlash. The influence on drug approval, pricing, and the role of patient advocacy groups are scrutinized, emphasizing the need for transparency and accountability. The article concludes by highlighting the complex challenges policymakers face in balancing innovation with public health.

This article explores the transformative shift toward patient-centric clinical trials, emphasizing active patient involvement in study design, recruitment strategies, and the integration of Patient-Reported Outcomes (PROs). By prioritizing transparency, communication, and digital health technologies, patient-centric trials enhance engagement, streamline recruitment, and improve data quality. The approach holds the potential to accelerate drug development, but challenges like regulatory hurdles and data privacy concerns must be addressed collaboratively for widespread implementation.

Quantum computing is a field that uses quantum mechanics to solve complex problems faster than classical computers. It emerged in the 1980s when it was discovered that certain computational problems could be tackled more efficiently with quantum algorithms than with their classical counterparts. Unlike classical computers that use bits, which can only be 1 or 0, quantum computing involves qubits that can exist in a multidimensional state. The power of quantum computers grows exponentially with more qubits, while classical computers that add more bits can increase power only linearly. Quantum

In this editorial, we explore the remarkable potential of artificial intelligence (AI) and machine learning (ML) in revolutionizing the field of drug design. Traditional drug discovery pipelines have long been plagued by high costs, lengthy timelines, and low success rates. However, with the advent of AI and ML, a new era of accelerated and improved drug design is on the horizon. This editorial highlight the various applications of AI and ML in drug design, including target identification, virtual screening, de novo design, synthesis prediction, and clinical trial optimization. We also addres

Globally, cancer has been referred to as one of the most debilitating diseases. The current treatment regimenfor the treatment of the same is limited to surgical, radiation, and chemotherapeutic interventions. However, these methods have a high risk of damage to healthy tissues, while not even conferring complete cancer eradication. With the advent of nanotechnology, the treatment landscape for cancer is projected to change. While these Nano particulate modalities are highly efficacious, they pose their set of caveats. Recent studies have corroborated the enormous potential of Plant-derived e

The global AI in the pharma market expanded to a size of nearly $699.3 million in 2020. The market is anticipated to increase at a rate of 32.9 %, from $699.3 million in 2020 to $ 2,895.5 million in 2025. Researchers claim that the application of these technologies enhances decision-making, maximizes creativity, increases the effectiveness of research and clinical trials, and produces new tools that benefit doctors, patients and regulators.Computer-aided drug designs have recently supplanted more traditional methods of medication development. A lot of AI is being applied to advance drug desig

Certainly, we are all alike, but we are all unique. And the notion that medication would be used in a way that overlooks those disparities is as absurd as walking to a sneaker store to pick up any old pair of sneakers without first verifying the size. Personalized medicine provides an excellent chance to transform a "one size fits all" strategy to diagnostics, pharmacological therapy, and treatment into a personalised strategy. Nanotechnology advancements have enabled the development of nanomaterials devices for the enhanced diagnosis and tailored treatment of a various range of complicated d

Dementia is the first sign of neuronal impairment related to Alzheimer’s disease (AD). The neurodegeneration initially appears in the hippocampus and cortex which comprises memory developing area of the brain and then spreads to additional areas of the brain causing significant shrinkage of the brain. Due to this abnormality accumulation of amyloid β plaques and tau tangles occurs consequently leading to disruption of the functioning of healthy neurons and loss of synaptic connections. Donepezil, memantine, rivastigmine, galantamine, and their combinations are primarily used for the treatment