European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

FDA 91

FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 91

Pharma Leaders

MAY 8, 2023

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticals’ pharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.

Manufacturing 52

Manufacturing Food and Drug Administration FDA Pharmaceutical manufacturing 52

European Pharmaceutical Review

NOVEMBER 8, 2022

The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 3) policing anticompetitive settlements between competing drug manufacturers. Citizen Petitions before the FDA. 5) monitoring access to biosimilars. Senate Bill 562 (S.

Food and Drug Administration 52

Food and Drug Administration Pharma Prescription Manufacturing 52

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. In perhaps the most significant moment for the U.S. 2022 was a fascinating year for biosimilars, but may prove dull to 2023.

Marketing 97

Marketing Competition Government Manufacturing 97

Pharmaceutical Technology

AUGUST 30, 2022

International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.

Manufacturing 78

Manufacturing Marketing Pharma Distribution 78

PM360

DECEMBER 20, 2023

At the same time, a “drug lag” persists in China for global pharmaceutical companies’ products. Between 2017 and 2021, the median time difference between the first global approval and the approval in China was five years 1. In 2021, the out-of-pocket (OOP) cost accounts for 28% of the whole healthcare expenses compared to 15.4%

Marketing 105

Marketing Insurance Medical Manufacturing 105

PM360

AUGUST 9, 2022

According to an August 2021 report from the Business Research Company , after experiencing a decline in 2020 due to pandemic, the medication adherence market is expected to recover and grow at a compound annual growth rate (CAGR) of 11.4% from 2021 and reach $4.2 The FDA 510(k) submission is expected to take place in Quarter 3 2023.

Prescription 105

Prescription Medical Side effects Patients 105