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European Medicines Agency

All articles tagged with #european medicines agency

health1 year ago

European Committee Reverses Stance, Approves Alzheimer's Drug

The European Medicines Agency's Committee for Medicinal Products for Human Use has reversed its earlier decision and now recommends approval of the Alzheimer's drug lecanemab, known as Leqembi in the U.S., for early-stage treatment. This comes after initial concerns about side effects like brain swelling and bleeding. Developed by Eisai and co-marketed with Biogen, the drug has shown to slow cognitive decline in Alzheimer's patients. The European Commission is expected to make a final decision on marketing authorization soon.

via Yahoo Finance|
#alzheimers#biogen#drug-approval
medicinehealthcare2 years ago

"Key Takeaways from CHMP's October 2023 Meeting | European Medicines Agency"

The European Medicines Agency's Committee for Medicinal Products Human Use (CHMP) recommended seven new medicines for approval, including treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, and hyperargininemia. The committee also granted extensions of therapeutic indications for eight medicines and initiated a review of the benefits and risks of a medicine used to treat primary biliary cholangitis.

via European Medicines Agency ||
#duchenne-muscular-dystrophy#european-medicines-agency#medicinehealthcare
health2 years ago

"EMA Endorses Pfizer's Updated Covid Vaccine for Winter Surge Amid Omicron Concerns"

Pfizer and BioNTech are prepared to distribute their updated Covid-19 vaccine across the European Union pending authorization from the European Commission, following a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Once authorized, the companies will be ready to ship doses immediately.

via Endpoints News|
#biontech#covid-19-vaccine#european-commission
health2 years ago

"European Medicines Agency Approves Pfizer's RSV Vaccine for Infants and Older Adults"

The European Medicines Agency (EMA) has recommended granting marketing authorization for Abrysvo, the first vaccine to protect against respiratory syncytial virus (RSV) in infants up to 6 months old and older adults. RSV is a common respiratory virus that can cause severe illness in children and older adults. Abrysvo is a bivalent vaccine that provides passive immunization to infants when administered to the mother during pregnancy and active immunization to adults aged 60 and older. The vaccine has shown efficacy in reducing RSV-associated illnesses in clinical trials. The opinion will now be sent to the European Commission for a decision on EU-wide marketing authorization.

via European Medicines Agency ||
#abrysvo#european-medicines-agency#health
health2 years ago

E.U. Investigates Ozempic and Saxenda for Possible Link to Suicidal Thoughts

The European Medicines Agency (EMA) is investigating Novo Nordisk's diabetes drug Ozempic and weight-loss treatment Saxenda after three cases of patients experiencing suicidal thoughts or self-harm were reported in Iceland. The EMA's safety committee is examining adverse events raised by the Icelandic Medicines Agency, including two cases of suicidal thoughts in individuals using Ozempic and Saxenda. Novo Nordisk stated that patient safety is their top priority and that their own safety monitoring has not found a causal association between the drugs and self-harming thoughts. The investigation also includes other medicines containing semaglutide or liraglutide, and the EMA may consider extending the review to other GLP-1 receptor agonists.

via NBC News|
#european-medicines-agency#health#novo-nordisk
health2 years ago

Rising Demand for Weight Loss Drugs Raises Safety Concerns

Europe's drugs regulator, the European Medicines Agency (EMA), is conducting a review of weight-loss jabs, including Wegovy, Saxenda, and similar drugs, after being alerted to a possible link to thoughts of suicide and self-harm among users. The review was prompted by three cases reported in Iceland. The EMA's Pharmacovigilance Risk Assessment Committee (PRAC) will assess the risks of using weight-loss medication containing semaglutide or liraglutide. Suicidal thoughts are already listed as a possible side effect in product leaflets, but suicidal behavior is not currently listed. The EMA will communicate further findings as the review progresses.

via BBC|
#european-medicines-agency#glucagon-like-peptide-1-receptor-agonists#health
healthcare2 years ago

ImmunoGen's Elahere shows promise in treating ovarian cancer, stock surges.

ImmunoGen's ovarian cancer drug, Elahere, demonstrated a statistically significant and clinically meaningful improvement in overall survival and progression-free survival compared to chemotherapy for folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer patients who have received therapy. The company plans to submit an MAA to the European Medicines Agency and an sBLA to the FDA in the second half of this year. As a result, ImmunoGen's stock soared by 112.46%.

via Yahoo Finance|
#elahere#european-medicines-agency#fda