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European Commission grants first-of-a-kind biosimilar approval
The approval means Sandoz’s Wyost® and Jubbonti® are the first biosimilars of denosumab authorised in Europe.
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osteoporosis
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Sandoz granted novel biosimilars approval
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
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Could novel robotic oral pill replace traditional injections?
An osteoporosis study has demonstrated a high delivery success rate for a breakthrough technology that converts injections into an oral pill, data from ENDO 2023 showed.
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Moving towards oral delivery of biologics
In this article, EPR’s Caroline Peachey speaks to Talat Imran, CEO of Rani Therapeutics, about progress towards oral delivery of biologics using robotic capsules.
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EMA human medicines committee (CHMP) highlights, November 2022
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
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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.
