news
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.
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US Food and Drug Administration (FDA)
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Pharmaceutical analysis with portable spectrometers
Richard Crocombe of Crocombe Spectroscopic Consulting surveys the use of portable spectrometers in pharmaceutical manufacturing, with an emphasis on vibrational spectroscopy. Ideal and typical features of portable spectrometers are reviewed, alongside explanation of why device characteristics and sample presentation are critical to obtaining meaningful results.
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Novel excipients for solubility enhancement
Lubrizol Life Science Health colleagues Nick DiFranco, Global Market Segment Manager for Oral Treatments, and Joey Glassco, Senior Global Market Manager for Parenteral Drug Delivery, explore the use of amorphous solid dispersions and polymeric micelles for solubility enhancement.
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Phase I oncology studies: rule- versus model-based design
In this article, Karen Ooms, Head of Statistics at Quanticate, compares the rule- and model-based approaches to Phase I trial design, exploring their benefits and weaknesses in defining maximum tolerated dose for oncology products.
news
Second COVID-19 vaccine ‘Spikevax’ is approved by the FDA
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
news
EC approves Lorviqua® (lorlatinib) as first-line lung cancer treatment
Lorviqua® monotherapy approved as first-line advanced non-small cell lung cancer therapy based on promising Phase III trial results.
news
Omicron prompts FDA to restrict use of specific antibodies
Based on the latest data, and Omicron's current dominance in the US, the FDA has announced two monoclonal antibody treatments are not authorised for use in any US states, territories and jurisdictions at this time.
podcasts
EPR Podcast Episode 8 – Oral biologic drug delivery with Giovanni Traverso, MIT
How close are we to oral biologic drug delivery? Will biomedical devices be essential in overcoming drug delivery challenges? Discover all this and more in this podcast with MIT's Assistant Professor Giovanni Traverso.
news
International regulators call for multivalent COVID-19 vaccines
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
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Key challenges for bio/pharmaceutical manufacturing 2022
What are the top six challenges facing pharmaceutical and biopharmaceutical manufacturers in 2022? We spoke to representatives from four contract manufacturing and development organisations (CDMOs) – Samsung Biologics, Lonza, MedPharm and Genezen – to find out.
news
New FDA medical device framework to improve women’s health
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
news
Rare Disease Clinical Outcome Assessment Consortium launched
The Rare Disease Clinical Outcome Assessment (COA) Consortium aims to advance patient-focused assessment of clinical benefit in treatment trials for rare diseases.
news
Enhertu granted Priority Review for HER2-positive breast cancer
US FDA grants Enhertu Priority Review based on promising trial results in certain patients with HER2-positive breast cancer.
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United efforts to accelerate drug development
From the Cancer Drug Development Forum (CDDF), John Smyth (Chairman), Axel Glasmacher (Treasurer) and Jaap Verweij (Managing Director) clarify the importance of a collaborative industry approach to cancer therapy development and highlight the most pressing challenges for discussion in their meetings and workshops.
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New developments in the pharmaceutical stress testing industry
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.
