Drug shortage Alert: Millions of patients affected as FDA reports shortfalls of essential drugs

[Image courtesy of Monkey Business/Adobe Stock]

Millions of U.S. patients are facing medication shortages, according to recent FDA data. The Adderall drug shortage in particular has received significant attention in recent months. Other notable drugs currently facing shortages include the bronchodilator Albuterol and the popular antibiotics amoxicillin and azithromycin.

The pandemic and supply chain challenges are partly to blame for the drug shortages. In recent years, manufacturing output for some drugs sank as a result of factors such as pandemic-induced restrictions and worker shortages. The pandemic also contributed to supply chain disruptions. For instance, China and India, both major suppliers of active pharmaceutical ingredients and other materials. As a result, the pharma industry has been forced to find new ways to ensure a steady supply of raw materials and ingredients.

To illustrate the imp…

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How the pandemic and George Floyd made clinical trial diversity a priority

[Image courtesy of Chad Davis via Flickr]

Where would clinical trial diversity be without the COVID-19 pandemic and the death of George Floyd on May 25, 2020? It likely wouldn’t be the priority it is today across the industry, according to Ariel Katz, CEO and co-founder of H1, a New York–based healthcare and data analytics platform firm.

After the death of George Floyd, scores of pharma companies created or beefed up departments related to diversity and inclusion. “Basically, every pharma company and biotech is now doing something around diversity and inclusion and social determinants of health,” Katz said.

On Google, interest in the search phrase ‘clinical trial diversity’ surged from July 2020 to July 2021. Interest in the phrase continues to remain strong but has dipped from its peak.

Things have changed considerably during the pandemic.

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How to improve quality assurance in the pharmaceutical industry

Avatour technology in use. Image courtesy of Avatour.

The pharmaceutical industry is expected to grow at an annual rate of 5-8% for the next three years. In just the past five years, a range of new technologies has been implemented to improve healthcare delivery, analytics and drug production. However, with the lingering challenges of COVID-19, the need for creative solutions has become more urgent than ever.

Routine quality assurance in the pharmaceutical industry has faced considerable challenges while adhering to schedules and production timelines and ensuring that quality compliances are maintained while maintaining social distancing and travel restrictions. Luckily, remote collaboration technologies with a unique 360° spatial view provide a solution that prevents the slowdown of pharmaceutical processes during the pandemic and may offer revolutionary benefits for future use.

The importance of QA in …
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The future of pharmacovigilance: Assessing the role of ML, NLP and other technologies

Image from Roberto Sorin via Unsplash

The field of pharmacovigilance has evolved significantly in recent years. While regulatory authorities have long favored technologies such as artificial intelligence and machine learning for monitoring patient safety, the trend has accelerated during the pandemic. “I’ve never seen as much advancement as I have in the last two years,” said Marie Flanagan, director, offering management, Vigilance Detect at IQVIA.

Flanagan predicted that regulators’ interest in AI and ML for pharmacovigilance will catalyze growing interest across the pharma industry in 2022 and beyond. The pandemic has demonstrated to regulators and life science companies that the technologies can help make sense of exploding volumes of pharmacovigilance data points.

“If we look at just the user vigilance database in the past two years — as of last week, 64% of all infor…

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9 predictions for pharma in 2022

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The pharma industry has been slower to embrace technologies such as AI and digital technology than many less-regulated sectors. The COVID-19 pandemic has changed the equation, forcing pharma companies to become more agile and open-minded in approaching drug discovery and development, including managing evolving clinical trials.

In this article, several experts offered their predictions of the trends that will be most meaningful in 2022.

1. Digital components drive new pharma value

Jaydev Thakkar

In 2022, a growing number of pharmaceutical companies will recognize how their products could deliver significantly improved outcomes with a digital component, predicted Jaydev Thakkar, chief operating officer of Biofourmis, which offers digital therapeutics and care-at-home solutions powered by AI. “This digital component c…

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Antivirals could be a vital weapon in the COVID-19 pandemic endgame

Transmission electron microscope image of SARS-CoV-2. Image from NIH.

Antivirals have several advantages over vaccines. They tend to be broadly effective against viral variants and offer faster-acting protection than vaccines. In addition, antivirals are usually simple to transport and don’t require ultra-cold storage. And oral antivirals would have an advantage in terms of the speed of protection they offer. For SARS-CoV-2, antivirals also could provide an alternative to vaccines in the scores of vaccine-hesitant people. Additionally, antivirals have a proven track record against other viruses like HIV and hepatitis C, where vaccines aren’t available.

“We need antivirals,” surmised Kamlendra Singh, a molecular microbiology and immunology professor at the University of Missouri (Columbia, Missouri).

“It’s not that the vaccines aren’t working. They are working wonders,” Singh said. But antivirals will …

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How Lilly Oncology is aiming to improve clinical trial diversity

Minorities tend to participate in clinical trials at far lower rates than their real-world demographics and prevalence of the disease, according to the American Society of Clinical Oncology. In addition, minorities often have worse outcomes for certain cancers than the broader public. For instance, the mortality rate for Black women with breast cancer is 40% higher than that of white women.

The pandemic, however, has highlighted persistent health disparities while offering potential strategies for improvement, according to Amy Davis, senior director of clinical development at Lilly Oncology.

The pandemic has popularized the use of decentralized trials. For instance, Lilly debuted decentralized capabilities in a recent breast cancer trial and will continue doing so for upcoming trials. “We are building in decentralized capabilities from the get-go — decreasing the number of in-person visits by half,” Davis said. The company is using remote data capture and offer…

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