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.

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Transportation Manufacturing 98

European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. Compliance with Annex 1 and FDA requirements imposes high standards for accuracy and precision of the analytical instruments used to assess the quality of water samples. The Analyst , 2022. References. 15, s.l. :

Food and Drug Administration 98

Food and Drug Administration Pharma Manufacturing Pharmaceutical 98

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%.

Pharma 94

Pharma Manufacturing Medicine Marketing 94

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.

Marketing 105

Marketing Insurance Medical Manufacturing 105

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.

Prescription 105

Prescription Medical Patients Side effects 105

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.

FDA 98

FDA Food and Drug Administration Media Pharmaceutical 98

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.

Marketing 97

Marketing Competition Government Manufacturing 97

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.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Government Pharmaceutical 105

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.

Manufacturing 52

Manufacturing Government Prescription Pharmaceutical manufacturing 52