Clostridioides difficile vaccine shows promise in Phase III trial
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
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Developing ultrafast THz–fingerprint Raman spectroscopy
New research demonstrates the potential of dual-detection impulsive vibrational spectroscopy (DIVS), an ultrafast Raman spectroscopy technique.
FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
EDQM remote inspections to become permanent part of inspection scheme
The EDQM will include Real-Time Remote Inspections (RTEMIS) as an integral part of its system for the supervision of manufacturers of active substances from 2022.
What to expect at the UK’s flagship event for Making Pharmaceuticals
1 March 2022 | By
Serious about Making Pharmaceuticals? Attend the UK’s largest event dedicated to supporting the future of the pharmaceutical product life-cycle.
Brian Henry selected as new MMIP Chair
Brian Henry, Global Head of Drug Product Design at Pfizer, is the new Chair of the Medicines Manufacturing Industry Partnership (MMIP), a body representing the voice of medicines manufacturing in the UK.
USP calls for industry input in developing mRNA quality guidelines
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
UK to support early-stage clinical research with £161 million
New funding for Clinical Research Facilities will boost delivery of first-in-human to early safety and efficacy trials across England.
EMA’s human medicines committee (CHMP) Feb meeting highlights
Highlights of the February 2022 meeting of EMA’s human medicines committee (CHMP) include the recommendation of 13 medicines for approval, along with updates to other drugs and COVID-19 vaccines.
Lilly to create $700mn Institute for Genetic Medicine
Investing $700mn to establish a new site, Eli Lilly plans to fuel the development of genetic medicines through the company’s new Institute for Genetic Medicine.
β-thalassemia patients achieve transfusion independence with gene therapy
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
EU adopts electronic product information standard for medicines
The Common Standard for electronic product information (ePI) is intended to improve delivery of information to patients and healthcare providers.
Recommendations published on medicine procurement across the EU
The EFPIA has published 10 recommendations to ensure that procurement practices across the EU are effective and sustainable, delivering high quality medicines for patients, in the right quantities and at the right time.
Pharmaceutical industry seeks to build public trust with new data principles
A new framework for how the pharmaceutical industry will use health data for research and development of cutting-edge new medicines has opened for consultation.
COPAXONE® label updated to help breastfeeding mothers with relapsing MS
The label update follows the review of clinical and non-clinical evidence, including latest data from a COBRA real world evidence study.
