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.
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Regulation & Legislation
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.
news
Novartis’ Pluvicto™ prostate cancer therapy approved by FDA
Novartis has received a boost to its arsenal of cancer therapeutics after the FDA approved Pluvicto™ and complementary diagnostic imaging agent Locametz® to treat advanced prostate cancer.
webinar
Enhancing nitrosamines analysis: a focus on NDSRIs
25 March 2022 | By SCIEX
Exploring the complexities of nitrosamines to enhance understanding and overall management, with a focus on nitrosamine drug substance-related impurities (NDSRIs).
news
FDA releases draft guidance for cell and gene therapy industry
The US FDA has published two draft guidance documents, one on gene therapy products and the other CAR T-cell therapies, for developers and manufacturers.
video
Video: Upgrade your tablet manufacturing process
Compliant, reliable, safe, and contained conveying of powders and pills in tablet manufacturing replaces manual handling or mechanical conveying.
news
Blood pressure tablets recalled due to high levels of nitrosamine
Pfizer is voluntarily recalling Accuretic tablets and two generic high blood pressure treatments, due to levels of nitrosamine above ADI.
news
USP Medicine Supply Map to help improve pharma supply chain resilience
Unveiling its Medicine Supply Map, the US Pharmacopeia (USP) showed how reliant the US pharma supply chain is on Indian API manufacturers.
news
Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, March 2022
EMA’s pharmacovigilance committee recommends product information updates for two COVID-19 vaccines - Janssen COVID-19 Vaccine and Moderna’s Spikevax.
article
Menopause, contraception, endometriosis: are women’s health issues finally being recognised?
Despite recent progress in women’s health issues, there are still many challenges women continue to face when accessing healthcare. Here, Alison Slingsby of HRA Pharma discusses the recent advancements made in the UK and where further development is required.
news
Phase III study shows safety of fezolinetant as non-hormonal treatment of VMS
The safety and efficacy of fezolinetant is being evaluated in the Phase III trial of over 1,800 women seeking relief from severe vasomotor symptoms associated with menopause (VMS).
