Impetus Digital

AUGUST 2, 2024

Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported. In 2022, the AI-fuelled pipeline reportedly expanded at an annual rate of almost 40%.

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PM360

AUGUST 9, 2022

The FDA 510(k) submission is expected to take place in Quarter 3 2023. Launched in July 2021, Prescryptive Health provides next-generation, mobile market access and medication adherence solutions for pharmaceutical manufacturers. Orbita Outreach. Patty Riskind. hello@orbita.ai.

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European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

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PM360

APRIL 25, 2023

biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. When broken out by therapeutic area, 76% percent of rheumatologists reported that they were “very familiar” with biosimilar products—a 43% increase over the 2022 survey.

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Pharmaceutical Technology

MARCH 22, 2023

Only 25% of API production for generic drugs took place in Europe in 2020, according to a November 2022 Medicines for Europe report. Due to the cessation of Russian gas imports following its invasion of Ukraine, electricity prices increased up to tenfold, and raw material costs rose by 50% to 160% in Q3 2022.

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PM360

MAY 25, 2023

The pandemic had a huge impact on the way population health decision-makers (PHDMs) navigate our industry, and now that it’s clear many of these shifts are here to stay, pharmaceutical manufacturers need to adjust accordingly. New Drug Therapy Approvals 2022.” That’s why an evolution of communications strategies is necessary.

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European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation.

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PM360

DECEMBER 20, 2023

Despite the disruptive impact of the COVID-19 pandemic, steady growth has been evident in China’s pharmaceutical market and research environment. From 2017 to 2022, the Chinese market witnessed a growth rate of 5.3%, compared to the average market growth of 6.6% Epub 2022 Nov 2. 2022 Jun 13;10(6):1099. in the U.S.

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European Pharmaceutical Review

APRIL 8, 2025

Implementing PAT in (bio)pharmaceutical manufacturing New sensors or larger equipment with more complex setups (software and hardware) require stringent procedures to become fully implemented in a good manufacturing practice (GMP) manufacturing facility. Good Design Practices for GMP Pharmaceutical Facilities.

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Clarivate

AUGUST 20, 2024

Announced on August 15, 2024, this first batch of Maximum Fair Prices (MFPs) were mandated by the Inflation Reduction Act of 2022 , which allowed CMS to negotiate what it describes as the maximum fair price for therapies representing the greatest cost to Medicare. billion in 2022 , the most recent year for which CMS data is available.

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