Dr Nicola Davies

Pharmaceutical industry consultant and commentator

Dr Nicola Davies is a leading authority on the pharmaceutical and life sciences industry. Her anthology of in-depth reports have covered many of the sector’s most important topics of today, including big data and analytics, biosimilars and investment trends. She writes columns for The Pharma Letter and other publications, and has advised and worked with big pharma companies, patient groups and the UK’s National Health Service.

Dr Davies is also on the Editorial Group of the EU Data Saves Lives initiative.

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Biotechnology

Illuminating Sjögren's syndrome

The month of July celebrated World Sjögren's Day, dedicated to Sjögren's syndrome (SS) – a condition affecting between 0.5% and 1% of the population.1 30 July 2024

Pharmaceutical

New drug news: Key highlights from the FDA’s 2023 Annual Report

The US Food and Drug Administration’s (FDA) Office of New Drugs (OND), part of the Center for Drug Evaluation and Research (CDER), plays a pivotal role in advancing public health by facilitating access to novel, effective and safe drugs that address unmet clinical needs. 29 July 2024

Pharmaceutical

Illuminating Huntington’s disease

Huntington's disease (HD) is a progressive neurodegenerative disorder characterized by involuntary movements, cognitive decline, and emotional disturbances.1 Recent global prevalence data cites 4.88 per 100,000 persons and an incidence of 0.48 cases per 100,000 person-years.2 13 May 2024

Pharmaceutical

Advancing pharmaceutical processes with AI: The FDA's perspective

As artificial intelligence (AI) and machine learning (ML) continue to revolutionize various industries, the pharmaceutical sector is no exception. Indeed, there has been a substantial surge in drug and biologic submissions incorporating AI/ML components, exceeding 100 submissions in 2021 alone.1 10 May 2024

Biotechnology

Illuminating Fabry disease - 2024 update

April is Fabry disease awareness month, which we are taking as an opportunity to explore advances in the pharmacological treatment of this rare disease. 4 April 2024

The landscape of biosimilars has rapidly evolved over the past decade, with the US Food and Drug Administration (FDA) spearheading efforts to enhance their approval and utilization. 3 April 2024

Pharmaceutical

Illuminating multiple system atrophy

March is designated multiple system atrophy (MSA) awareness month, which we have taken as an opportunity to delve into advances in treatment for this rare disorder. 18 March 2024

Biotechnology

New FDA draft guidance on potency assurance for cellular and gene therapy products

Cell and gene therapies (CGTs) have shown impressive clinical benefits for patients worldwide, with 89 approved therapies reported globally as of second-quarter 2023. 15 March 2024

Biotechnology

FDA invites stakeholder input on draft potency assurance guidance

In December 2023, the US Food and Drug Administration (FDA) released a 25-page draft guidance on Potency Assurance for Cellular and Genetic Therapy Products.1 1 March 2024

Biotechnology

Rare Disease Day: What is pharma doing for rare diseases?

In 2023, more than 50% (28 of 55) of the novel drugs reviewed by the US Food and Drug Administration (FDA) received orphan drug designation for the prevention, diagnosis, or treatment of a rare disease.1 20 February 2024

Pharmaceutical

Illuminating medullary thyroid carcinoma

Medullary thyroid carcinoma (MTC) is a rare neuroendocrine condition that develops in the parafollicular C cells of the thyroid gland.1 It makes up 3%-5% of all thyroid cancers, with a 10-year mortality rate of about 50%.2 20 January 2024

Biotechnology

The primary factors behind FDA holds of 2023

While 2023 saw the approval of many notable new drugs by the US Food and Drug Administration (FDA), the past year also featured many holds being imposed on clinical trials. 18 January 2024

Pharmaceutical

Rare disease drug development in 2023 and beyond

Rare disease drug development has grown exponentially in recent years, and 2023 has continued to expand on this trend.1 13 December 2023

Pharmaceutical

The FDA seeks stakeholder input into AI/ML regulatory standards

Artificial intelligence (AI) has become an integral part of our daily lives. Within the pharmaceutical industry, AI and machine learning (ML) are being harnessed to aid many aspects of drug development and data analysis. 27 November 2023

Pharmaceutical

Illuminating complex regional pain syndrome

Complex regional pain syndrome (CRPS) is a chronic and potentially debilitating neuropathic pain condition that typically affects an extremity, such as an arm or leg.1 22 November 2023

Generics

Translating science to approval: The GDUFA science and research program

In September 2022, the US President re-authorized the Generic Drug User Fee Amendments (GDUFA). This new iteration is known as GDUFA III and takes effect from October 2022 to September 2027.1 21 September 2023

Pharmaceutical

Drug products containing nanomaterials: New FDA guidelines

Nanomaterials have revolutionized biotherapeutics, functioning in a variety of roles ranging from active ingredients to drug carriers. Although no regulatory definition of nano-based drugs (drug products containing nanomaterials) has ever been established, these drugs have two distinct characteristics:1 31 October 2022

Pharmaceutical

Illuminating Charcot-Marie-Tooth disease

Charcot-Marie-Tooth Disease (CMT) is a group of hereditary disorders characterized by sensory loss, muscle weakness and atrophy. As a result of damage to peripheral nerve axons and the myelin surrounding them, nerve cells of individuals with CMT are unable to properly send electrical signals to motor nerves and sensory peripheral nerves. 1 October 2022

Biosimilars are compounds that have demonstrated no clinically meaningful differences in safety, purity and potency from a reference biologic drug. As of September 2022, 38 biosimilars have been approved for use within the USA. 29 September 2022

Pharmaceutical

Accelerated approvals: The reality behind confirmatory trial delays

The accelerated approval pathway (AAP), which was first introduced by the US Food and Drug Administration (FDA) in 1992 to tackle the HIV epidemic, enables expedited development and approval of new therapies for serious diseases that lack efficient treatment options.1,2 26 August 2022

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