• Regulatory NewsRegulatory News

    PRAC investigates heart inflammation reports with Pfizer vaccine

    During an early May meeting, the European Medicines Agency’s safety committee concluded two reviews of safety signals related to COVID-19 vaccines, while it continued following other vaccine-related “topics of interest.” These included reports of heart muscle inflammation after receipt of the Pfizer-BioNTech vaccine.   EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) wrapped up a review of reports of facial swelling in recipients of Pfizer’s COVID-19 vaccine, k...
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    CHMP recommends eight new medicines in April, including two orphans

    In its April meeting, the European Medicines Agency’s (EMA’s) human medicines committee recommended eight new medicines for approval, including three new non-orphan medicinal products and two orphan medicines.   EMA’s Committee for Medical Products for Human Use (CHMP) also issued positive opinions for extensions of therapeutic indications for nine medicines, bringing the total new indications for 2021 to 23.   Leo Pharma’s Adtralza (tralkinumab) was recommended ...
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    CHMP recommends five new drugs, gives advice on Celltrion COVID antibody

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday issued positive opinions for five new medicines and six extensions of therapeutic indications following its meeting earlier this week.   The newly recommended medicines include Verastem’s Copiktra (duvelisib) to treat relapsed or refractory chronic lymphocytic leukemia and refractory follicular lymphoma and Janssen-Cilag’s multiple sclerosis treatment Ponvory (ponesimo...
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    CHMP’s February recommendations: Evrysdi, Jemperli, and a generic for prostate cancer

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA’s CHMP) recommended six new medicines for approval when it met in February, including two biosimilars and one generic medicine.   The committee recommended marketing authorization for Roche’s Evrysdi (risdiplam) for the treatment of certain types of spinal muscular atrophy (SMA). It is the first oral treatment for this condition and was reviewed under the EMA’s accelerated assessment pr...
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    EMA plots earlier engagement with patient groups

    The European Medicines Agency’s (EMA) on Friday announced it will pilot an early engagement program to bring patient and consumer groups to the table with its human medicines committee earlier in the evaluation process.   In its proposal for the pilot, EMA says there are “missed opportunities” for its Committee for Medicinal Products for Human Use (CHMP) to incorporate patient perspectives into its reviews, as patient input is typically sought late in the process and o...
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    CHMP's January recommendations: Kesimpta, Ontozry, bevacizumab biosimilars, and more

    The European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA’s CHMP) recommended 13 new medicines for approval when it met in January.   The committee recommended conditional marketing authorization for AstraZeneca’s vaccine against COVID-19 in individuals aged 18 years and up. (RELATED: EMA authorizes AstraZeneca COVID-19 vaccine , Regulatory Focus 29 January 2021).   Teva’s twin formulations, Seffalair Spiromax and Bropair Spiromax (sal...
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    CHMP closes out 2020 by recommending 15 medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended 15 medicines for authorization following its December meeting.   Among the medicines are eight new drugs and biologics, four generics, two biosimilars and one hybrid medicine. The new drugs included three products with orphan designation: AstraZeneca’s Lumoxiti (moxetumomab pasudotox), which was recommended under exceptional circumstances to treat relapsed ...
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    EU Regulatory Roundup: CHMP Questions Delay Novartis Gene Therapy Approval Timeline

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU   regulatory news.   CHMP Questions Delay Novartis Gene Therapy Approval Timeline   Tougher than expected regulatory scrutiny has delayed Novartis’ efforts to bring its spinal muscular atrophy gene therapy Zolgensma to patients in Europe. Novartis had hoped to win approval by the end of the year, but now expects the Committee for Medicinal Products for Human Use (CHMP) to deliver its op...
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    EMA’s CHMP Recommends First Ebola Vaccine, 6 Other Medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced recommendations for seven new medicines for approval, including a conditional marketing authorization for Merck’s Ebola vaccine Ervebo (rVSVΔG-ZEBOV-GP, live), which is the first vaccine for those 18 years and older at risk of infection with the Ebola virus. EMA said that preliminary data suggest the vaccine is effective in the current Ebola outbreak in the De...
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    Novartis’ Zolgensma Joins Growing List of Medicines to Lose Accelerated Assessment Status in EU

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently announced its decision to remove Novartis’ spinal muscular atrophy gene therapy onasemnogene abeparvovec from its accelerated assessment program. CHMP did not announce its reasoning behind the decision, which effectively means that the treatment, approved in the US as Zolgensma and launched at a price of more than $2 million, will be reviewed in the EU in 210 days rather...
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    EMA Recommends First All-Oral Treatment for Sleeping Sickness

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday announced it has adopted a positive scientific opinion of Fexinidazole Winthrop (fexinidazole), the first oral-only medicine for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness.   This approval is a result of clinical trials led by the non-profit research and development organization DNDi, with an application submitted to EMA b...
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    EMA Backs Six Drugs, One Biosimilar for EU Approval

    The European Medicines Agency (EMA) on Friday said that its Committee for Medicinal Products for Human Use (CHMP) is recommending six new drugs, a biosimilar and three generic medicines for EU approval. The six medicines the agency is recommending are: Dr. Falk Pharma's Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the esophagus. Jorveza was granted an accelerated assessment and orphan designation; Merck Sharp & Dohme's Pr...