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 98

FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing 98

Impetus Digital

AUGUST 2, 2024

Looking back at 2023 , AI for drug discovery saw both wins and losses. Manufacturing Optimization While the manufacturing industry lags behind others in terms of AI uptake, there is no shortage of potential ways to leverage this technology. In 2022, the AI-fuelled pipeline reportedly expanded at an annual rate of almost 40%.

Pharma 92

Pharma Manufacturing Medicine Marketing 92

European Pharmaceutical Review

OCTOBER 3, 2024

While it officially applies to the manufacture of sterile medicinal products in the European Union, the revised EU Good Manufacturing Practice (GMP) Annex 1 effectively reset the benchmark for quality standards across the globe on 25 August 2023.

Manufacturing 52

Manufacturing Pharmaceutical manufacturing Pharmaceutical Education 52

European Pharmaceutical Review

NOVEMBER 8, 2022

Pharmaceutical manufacturers have submitted Citizen Petitions raising safety or efficacy concerns about proposed competing generic and biosimilar products, and such submissions often delay FDA approval of the proposed products while the FDA resolves the pending petitions.

Food and Drug Administration 52

Food and Drug Administration Pharma Manufacturing Prescription 52

PM360

AUGUST 9, 2022

Needles cause patients pain, anxiety, pose safety risks, and for some people receiving injection therapy is a traumatic experience. The FDA 510(k) submission is expected to take place in Quarter 3 2023. Pharmaceutical manufacturers can customize the solution based on the brand’s objectives and patient population’s needs.

Prescription 105

Prescription Medical Patients Side effects 105

Clarivate

MARCH 14, 2024

Nitrosamines have garnered significant attention from the pharmaceutical industry due to their detection in commonly prescribed medications for conditions like type 2 diabetes, high blood pressure, and heartburn. [1] Manufacturers, healthcare providers, and consumers alike face the need to quickly adapt.

Pharmaceutical 52

Pharmaceutical Manufacturing Food Healthcare Provider 52

PM360

APRIL 25, 2023

Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. pharmaceutical industry. 2022 was a fascinating year for biosimilars, but may prove dull to 2023.

Marketing 97

Marketing Competition Government Manufacturing 97

European Pharmaceutical Review

OCTOBER 12, 2023

September 2023 saw a wave of new pharmaceutical manufacturing facility expansions and launches across Europe. Research by the Confederation of British Industry (CBI) , released in September this year, highlighted progress for UK manufacturing in its latest Industrial Trends Survey. Meath opened last month.

Pharmaceutical manufacturing 104

Pharmaceutical manufacturing Manufacturing Pharmaceutical Pharma 104

Medico Reach

FEBRUARY 8, 2023

The global pharmaceutical manufacturing market stood at USD 405.52 The paradigm shift towards integrated, intelligent, and data-rich technologies is propelling the growth of medicines manufacturing. The paradigm shift towards integrated, intelligent, and data-rich technologies is propelling the growth of medicines manufacturing.

Pharma 52

Pharma Medicine Marketing Prospecting 52

PM360

DECEMBER 20, 2023

market (source: IQVIA MIDAS, May 2023). At the same time, a “drug lag” persists in China for global pharmaceutical companies’ products. billion people in 2023). In the 2023 NRDL, 121 drugs succeeded in the negotiation and bidding among 147 participants (success rate of 82.3%). in the U.S.

Marketing 105

Marketing Insurance Medical Manufacturing 105

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. GMP Audits in Pharmaceutical and Biotechnology Industries.

Manufacturing 52

Manufacturing Food and Drug Administration Management Pharmaceutical 52