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Eli Lilly shares impressive hair regrowth results with Olumiant® for alopecia
The results of Eli Lilly and Company’s double-blind, placebo-controlled Phase III trials for Olumiant® are encouraging for patients suffering with alopecia.
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US Food and Drug Administration (FDA)
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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.
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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.
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FDA releases draft guidance for cell and gene therapy industry
The US FDA has published two draft guidance documents, one on gene therapy products and the other CAR T-cell therapies, for developers and manufacturers.
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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.
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Potential for a new one-and-done COVID-19 treatment
Investigational drug Lambda reduced risk of COVID-19-related death in one of the largest studies of its kind to date.
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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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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).
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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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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.
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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.
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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.
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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.
