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Article: Strategies for comparator sourcing
Best practices for leveraging the resources of sourcing vendors are vital to anticipating and avoiding clinical supply delays.
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Regulation & Legislation
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Fenfluramine found effective in preventing drop seizures from LGS
Phase III trial shows fenfluramine as an adjunct to existing anti-epileptic treatment is effective in reducing the frequency of drop seizures from Lennox-Gastaut Syndrome (LGS).
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The latest on pharmaceutical counterfeiting
Here, EPR’s Hannah Balfour discusses the latest reports on pharmaceutical counterfeiting and falsification, exploring global and European crime rates, as well as recent counterfeiting incidents reported by Big Pharma.
video
On-demand webinar: Mould contamination, investigation and remediation challenges
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
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EMA’s human medicines committee (CHMP) April 2022 meeting highlights
At its latest meeting, EMA’s human medicines committee (CHMP) recommended the approval of four medicines, seven extensions of therapeutic indication and laid out recommendations for diabetes treatment outside of the EU.
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Article: Choosing a CDMO for high potent manufacture
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.
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European Pharmaceutical Review Issue 2 2022
Features in this issue discuss how bioprocessing must adapt to meet the needs of autologous cell therapies, the role of mass spectrometry in enhancing antibody consistency and the economic benefits of embracing continuous manufacturing. Also in this journal, articles exploring the development of precision medicine for chronic diseases, why acoustic…
news
Draft guidance to improve US clinical trial diversity
The new clinical trial guidance asks sponsors to submit a Race and Ethnicity Diversity Plan outlining how they plan to enrol participants from underrepresented populations.
news
CFD airflow stimulations can help enhance cleanroom contamination control, finds study
Researchers used computational fluid dynamics (CFD) simulations to assess their cleanroom airflow and suggest improvements that would reduce contamination levels.
whitepaper
Guide: Analytical applications in pharmaceuticals
The examples of common applications in the pharmaceutical industry for titration, UV/VIS spectroscopy and physical values are presented in details.
news
FDA approves first drug for PIK3CA-Related Overgrowth Spectrum (PROS) conditions
Novartis’ Vijoice® (alpelisib) is the first and only treatment approved for the treatment of the rare spectrum of conditions associated with PROS in certain patients.
webinar
Microbial investigations: a new paradigm from PDA
7 April 2022 | By Charles River
Watch experts discuss key aspects of microbial investigations, helping you to understand and implement the new PDA Technical Report 88, and sharing their experience of investigating various microbial events in the real world.
news
Teva recalls one lot of IDArubicin Hydrochloride Injection USP
Lot 31329657B of Teva’s IDArubicin Hydrochloride Injection USP 5mg/5ml vials is being recalled across the US due to particulates.
news
US FDA calls for 34 percent increase in funding
The FDA has requested a 2023 budget of $8.4 billion from the US Government, a $2.1 billion increase in funding from 2022.
news
EMA human medicines committee (CHMP) meeting highlights, March 2022
The March meeting saw the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommend five medications for approval including a multiple myeloma gene therapy.
