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EMA human medicines committee (CHMP) highlights, September 2022
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
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How can evidence-based medicine (EBM) methodology support drug withdrawals?
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…
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CHMP meeting highlights, January 2022
The EMA’s Human Medicines Committee (CHMP) recommended approval of Paxlovid for COVID-19 and a new gene therapy for large B-cell lymphomas.
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Common osteoporosis treatments could reduce incidence of COVID-19
Osteoporosis treatments including denosumab, zoledronate and calcium could protect patients against COVID-19, researchers have said.
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Using rafts to enhance bioavailability of ibandronate
Researchers have developed a novel tablet formulation of ibandronate which increases the oral bioavailability of the drug by releasing it from a hydrogel raft formed in the stomach.
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UK vaccine clinical trial outsourcing expansion continues
An outsourcing company has announced that Phase II, III and IV clinical trials of vaccines will continue at a growing number of sites, assessing the safety of each in light of COVID-19.
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EC approves treatment for severe osteoporosis postmenopausal women
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
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Seven medicines recommended for approval by EMA
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.
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Terrosa® osteoporosis biosimilar treatment launched in Europe
A new biosimilar drug to treat osteoporosis is now available across Europe after the patent for its reference product expired.
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EMA releases medicinal approval recommendations
The EMA has given its approval recommendation to three drugs and announced negative opinions for approval on others.
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FDA approves Prolia for glucocorticoid-induced osteoporosis
The FDA has approved the use of Prolia for the treatment of glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture...
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EMA accepts MAA for romosozumab in the treatment of osteoporosis
The EMA has accepted the Marketing Authorization Application for romosozumab in the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture...
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Romosozumab provides protection against fractures in osteoporosis
A new treatment for osteoporosis provides major improvements in bone density and fractures than the current standard treatment...
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Pfizer and Lilly receive FDA fast track designation for tanezumab
The FDA has granted fast track designation for Pfizer and Eli Lilly’s tanezumab for the treatment of chronic pain in patients with osteoarthritis...
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UCB and Amgen submit FDA application for Osteoporosis drug
22 July 2016 | By Niamh Louise Marriott, Digital Content Producer
UCB and Amgen today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for romosozumab, an investigational, monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture...
