Latest news with #EMA
See - Sada Elbalad
4 hours ago
- Climate
- See - Sada Elbalad
Hot, Humid Weather Expected for Egypt on Thursday, Cairo 34°
Yara Sameh The Egyptian Meteorological Authority (EMA) predicts hot and humid weather will prevail in most of the country during Thursday's daylight hours. Extremely hot and humid weather is also expected to prevail in South Sinai and the south of the country. The weather will seem hotter due to the high humidity levels, which will push up the heat index 2-4 degrees. The country will also witness mist on agricultural and highway roads from the north of the country to Cairo. Wind will occur occasionally across the country. Light to moderate rainfall is predicted to prevail in Halayeba at intermittent periods. Light rain is also predicted to hit intermittently the North Coast and North Upper Egypt. Furthermore, maritime navigation is also expected to be disrupted in the shores of Marsa Matruh, El-Alamein, and Alexandria, with winds averaging 40 to 60 km/h and waves ranging between 2:3.5 meters. Maritime navigation will be disrupted in the Gulf of Suez, with winds averaging 40 to 55 km/h and waves ranging between 2:3 meters. Moreover, the Mediterranean Sea will experience moderate to turbulent waves ranging between 2 and 3 meters in height with northwest surface winds. Waves in the Red Sea will be moderate, ranging between 1.5 and 2 meters in height, varying between northwest and northeast surface winds. Moderately hot weather is also expected to prevail in Egypt at night and in the early hours. The predicted temperatures for the following cities are 34°C in Cairo, 31°C in Alexandria, 30°C in Marsa Matruh, 40°C in Sohag, 43°C in Qena, and 44°C in Aswan. read more Gold prices rise, 21 Karat at EGP 3685 NATO's Role in Israeli-Palestinian Conflict US Expresses 'Strong Opposition' to New Turkish Military Operation in Syria Shoukry Meets Director-General of FAO Lavrov: confrontation bet. nuclear powers must be avoided News Iran Summons French Ambassador over Foreign Minister Remarks News Aboul Gheit Condemns Israeli Escalation in West Bank News Greek PM: Athens Plays Key Role in Improving Energy Security in Region News One Person Injured in Explosion at Ukrainian Embassy in Madrid News Israeli-Linked Hadassah Clinic in Moscow Treats Wounded Iranian IRGC Fighters Arts & Culture "Jurassic World Rebirth" Gets Streaming Date News China Launches Largest Ever Aircraft Carrier News Ayat Khaddoura's Final Video Captures Bombardment of Beit Lahia Videos & Features Tragedy Overshadows MC Alger Championship Celebration: One Fan Dead, 11 Injured After Stadium Fall Business Egyptian Pound Undervalued by 30%, Says Goldman Sachs Lifestyle Get to Know 2025 Eid Al Adha Prayer Times in Egypt Arts & Culture South Korean Actress Kang Seo-ha Dies at 31 after Cancer Battle Arts & Culture Lebanese Media: Fayrouz Collapses after Death of Ziad Rahbani Sports Get to Know 2025 WWE Evolution Results
Medscape
18 hours ago
- Health
- Medscape
EMA Reverses Previous Refusal of Kisunla for Alzheimer's
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Kisunla (donanemab, Eli Lilly Nederland) for treating early symptomatic Alzheimer's disease in adults who are apolipoprotein E epsilon 4 noncarriers or heterozygotes. This recommendation overturns the previous negative opinion issued earlier this year by the committee, which concluded that the benefits of this medicine did not outweigh the risks of potentially fatal events associated with amyloid-related imaging abnormalities (ARIA), including brain swelling and the potential for bleeding. Kisunla's active substance is donanemab, a monoclonal antibody that targets and clears amyloid-beta plaques in the brain, a key feature of Alzheimer's disease. By reducing plaque burden, the therapy aims to slow cognitive decline in the early symptomatic stage of the disease. Kisunla will be available as a 350 mg concentrate for solution for intravenous infusion. The CHMP's positive opinion was based on data from the phase 3 TRAILBLAZER-ALZ 2 trial, which enrolled 1736 participants aged 60-85 years with early symptomatic Alzheimer's disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology, as confirmed by PET imaging. Participants were randomized to receive either donanemab (n = 860) or placebo (n = 876) intravenously every 4 weeks for 72 weeks. Donanemab significantly improved integrated Alzheimer's Disease Rating Scale (iADRS) and Clinical Dementia Rating Scale Sum of Boxes scores compared with placebo. In the low/medium tau population, the change in iADRS at 76 weeks was -6.02 for donanemab vs -9.27 for placebo. The most common side effects associated with donanemab are ARIA and headache. Other reported side effects include infusion-related reactions. The European Commission will now review the CHMP's recommendation to make a final decision on Kisunla's marketing authorization in the European Union. If approved, treatment should be initiated by clinicians experienced in Alzheimer's management, with access to MRI, and under the supervision of a multidisciplinary team trained in managing ARIA and infusion-related reactions. Detailed usage recommendations will be outlined in the product's summary of characteristics, which will be published on the EMA website after marketing authorization.
See - Sada Elbalad
a day ago
- Climate
- See - Sada Elbalad
Hot, Humid Weather Hits Egypt on Wednesday, Cairo 35°C
Yara Sameh The Egyptian Meteorological Authority (EMA) predicts hot and humid weather will prevail in most of the country during Wednesday's daylight hours. Extremely hot and humid weather is also expected to prevail in South Sinai and the south of the country. The weather will seem hotter due to the high humidity levels, which will push up the heat index 2-4 degrees. The country will also witness mist on agricultural and highway roads from the north of the country to Cairo. Wind will occur occasionally in the South Sinai and the Red Sea mountain trail. Light to moderate rainfall is predicted to prevail in Halayeba at intermittent periods. Furthermore, the Mediterranean Sea will experience moderate waves ranging between 1.5 and 2.25 meters in height with northwest surface winds. The Red Sea will experience moderate waves, ranging between 1.5 and 2.25 meters in height, varying between northwest and northeast surface winds. Moderately hot weather is also expected to prevail in Egypt at night and in the early hours. The predicted temperatures for the following cities are 35°C in Cairo, 31°C in Alexandria, 30°C in Marsa Matruh, 41°C in Sohag, 43°C in Qena, and 45°C in Aswan. read more Gold prices rise, 21 Karat at EGP 3685 NATO's Role in Israeli-Palestinian Conflict US Expresses 'Strong Opposition' to New Turkish Military Operation in Syria Shoukry Meets Director-General of FAO Lavrov: confrontation bet. nuclear powers must be avoided News Iran Summons French Ambassador over Foreign Minister Remarks News Aboul Gheit Condemns Israeli Escalation in West Bank News Greek PM: Athens Plays Key Role in Improving Energy Security in Region News One Person Injured in Explosion at Ukrainian Embassy in Madrid News Israeli-Linked Hadassah Clinic in Moscow Treats Wounded Iranian IRGC Fighters Arts & Culture "Jurassic World Rebirth" Gets Streaming Date News China Launches Largest Ever Aircraft Carrier News Ayat Khaddoura's Final Video Captures Bombardment of Beit Lahia Videos & Features Tragedy Overshadows MC Alger Championship Celebration: One Fan Dead, 11 Injured After Stadium Fall Lifestyle Get to Know 2025 Eid Al Adha Prayer Times in Egypt Business Egyptian Pound Undervalued by 30%, Says Goldman Sachs Arts & Culture South Korean Actress Kang Seo-ha Dies at 31 after Cancer Battle Arts & Culture Lebanese Media: Fayrouz Collapses after Death of Ziad Rahbani Sports Get to Know 2025 WWE Evolution Results
Medscape
2 days ago
- Health
- Medscape
EMA Says No to Knee Cartilage Repair Therapy Jelrix
At its July 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended refusing marketing authorization for Jelrix (autologous cartilage-derived articular chondrocytes), a product intended to repair injury-related cartilage defects in the knee. Jelrix is an advanced therapy medicinal product that uses a patient's own cartilage cells that are expanded in a lab and then implanted back into the knee to repair the defect. It was developed for patients with symptomatic cartilage defects of 2 cm² to 12 cm² whose bones have finished growing. In its decision, the EMA cited concerns about the lack of data to ensure consistent quality of the medicine through its manufacturing process and control strategy. No Verifiable Improvement The application was supported by a main study involving 100 patients with cartilage defects in the knee. The primary effectiveness measure was the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS), which evaluates pain, symptoms, and quality of life on a 0-100 scale, with higher scores indicating fewer symptoms. Assessments were conducted at 24 and 60 months post-treatment. Results were compared indirectly to outcomes from a separate microfracture registry rather than via a randomized control group. While patients who received Jelrix showed improvement in their KOOS scores at 24 and 60 months, the EMA noted that the study lacked a comparator group. This means the improvements could not be definitively attributed to Jelrix, as they might have resulted from the surgery and rehabilitation all participants received. Therefore, the agency concluded that the benefits of Jelrix did not outweigh its risks. The company confirmed there are no ongoing clinical trials or compassionate use/expanded access programs involving Jelrix in the EU. The applicant, Tissue Engineering Technologies AG, may request reexamination within 15 calendar days of receiving EMA's opinion. If pursued, CHMP will reassess their application based on any additional data provided.
Medscape
2 days ago
- Health
- Medscape
EMA Turns Down Nurzigma for Huntington Disease
At its July 2025 meeting, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended against granting marketing authorization in the European Union for Nurzigma (pridopidine, Prilenia Therapeutics) for treating adults with Huntington disease. Huntington disease is a rare, inherited, and fatal neurodegenerative disorder characterized by progressive motor, cognitive, and psychiatric symptoms. It affects approximately 5-10 individuals per 100,000 in the European population, which translates to an estimated 25,000-50,000 cases across the European Union. However, it currently lacks approved therapies to slow its progression. The available treatments only offer limited symptom control for Huntington disease-related complications, including chorea and behavioral issues. The active substance in Nurzigma, pridopidine, functions as an agonist of the sigma-1 receptor (S1R) within cellular structures, modulating pathways crucial for neuronal health and viability. This action on S1R is thought to ameliorate cellular dysfunctions associated with neuronal injury and Huntington disease, facilitating neurogenesis and attenuating oxidative stress, slowing neurodegenerative processes. Primary Endpoints Unmet in Trials Multiple clinical trials — including HART, MermaiHD, and PRIDE-HD — showed that, while pridopidine was generally safe and well tolerated, it failed to meet its primary motor endpoints. Despite this, post-hoc analyses suggested potential benefits in total functional capacity (TFC) in some patients. TFC scores assess how well individuals can perform day-to-day activities, including managing household tasks, finances, work, driving, and cooking. These findings led to the phase 3 PROOF-HD trial, which focused on functional outcomes rather than motor symptoms. However, the trial did not meet its primary endpoint, which was the change in TFC, in the overall study population. Post-hoc subgroup analyses showed potential benefits, particularly in patients not taking antidopaminergic medications. While these findings offered some insights into potential drug efficacy, the CHMP found them insufficiently robust and lacking in external validity. Despite setbacks, Prilenia Therapeutics and Ferrer said they are committed to advancing Nurzigma for Huntington disease, with new global studies planned to confirm its effectiveness. The companies have confirmed that the EMA's negative opinion on Nurzigma has no impact on patients currently enrolled in clinical trials or receiving the drug through compassionate use programs. Ongoing access and treatment protocols remain unchanged. However, patients should consult their clinical trial investigators for specific information regarding their continued treatment.
