AbbVie’s preventative migraine treatment atogepant (Qulipta™) shows promise
AbbVie releases promising results from its Phase III trial of atogepant (Qulipta™) for preventative treatment of chronic migraine.
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AbbVie releases promising results from its Phase III trial of atogepant (Qulipta™) for preventative treatment of chronic migraine.
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
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.
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.
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.
The FDA has approved a second vaccine, marketed as Spikevax, shown to be 93 percent effective in preventing COVID-19.
Lorviqua® monotherapy approved as first-line advanced non-small cell lung cancer therapy based on promising Phase III trial results.
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.
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.
Regulators encourage the development of bivalent or multivalent variant COVID-19 vaccines to continue to combat the disease and its variants.
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.
The FDA’s Center for Devices and Radiological Health releases its strategic plan to improve medical device research and regulation for women.
The Rare Disease Clinical Outcome Assessment (COA) Consortium aims to advance patient-focused assessment of clinical benefit in treatment trials for rare diseases.
US FDA grants Enhertu Priority Review based on promising trial results in certain patients with HER2-positive breast cancer.