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CHMP meeting highlights – December 2022
A total of five drugs were recommended for approval at the CHMP’s December meeting, including a gene therapy and two cancer drugs.
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OLUMIANT® (baricitinib)
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JAK inhibitors increase risk of cardiovascular problems and cancer, warns PRAC
Janus kinase inhibitors used for chronic inflammatory conditions are only safe for certain patients, advises the EMA’s safety committee.
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EMA’s human medicines committee (CHMP) May 2022 meeting highlights
The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
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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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Baricitinib reduces mortality of hospitalised COVID patients by 46 percent
New data shows Lilly’s Olumiant (baricitinib) significantly reduces the risk of death in hospitalised COVID-19 patients receiving invasive mechanical ventilation or ECMO.
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EMA to assess if Olumiant should be authorised for hospitalised COVID-19 patients
The EMA will conduct an accelerated assessment and issue its decision on whether Olumiant (baricitinib) can be used in hospitalised COVID-19 patients by July.
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Baricitinib enhances hair regrowth for alopecia areata patients
New Phase III data shows once daily treatment with baricitinib significantly increases hair regrowth in adult patients with severe alopecia areata.
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EMA recommends seven medicines for approval after September meeting
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
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Baricitinib and remdesivir reduce time to recovery in COVID-19 patient trial
A study of baricitinib in combination with remdesivir has met its primary endpoint in COVID-19 patients, by reducing time to recovery in comparison with only remdesivir.
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Eli Lilly’s COVID-19 therapies to enter clinical trials
The enterprise announced its drug OLUMIANT® (baricitinib) and an investigational antibody will enter clinical trials in US COVID-19 patients later this month.
