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CHMP recommends EU approval of Roche ’s Alecensa as the first adjuvant treatment for resected ALK-positive early-stage lung cancer
If approved, Alecensa will be the first and only ALK inhibitor approved for people with resected ALK-positive early-stage non-small cell lung cancer (NSCLC)The positive recommendation is based on results from the Phase III ALINA study where Alecensa showed an unprecedented 76% reduction in the risk of disease recurrence or death, compared to adjuvant chemotherapy1With about half of people living with early-stage NSCLC experiencing disease recurrence or death following surgery, Alecensa could minimise the risk by treating NSCLC before it has spread2Basel, 26 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today th...
Source: Roche Investor Update - April 26, 2024 Category: Pharmaceuticals Source Type: news

Roche ’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS
Results from the Phase III study showed that subcutaneous (SC) injection was consistent with IV infusion and demonstrated near-complete suppression of relapse activity (97%) and MRI lesions (97.2%) through 48 weeksThe twice-yearly, 10-minute SC injection has the potential to expand the usage of OCREVUS to treatment centres without IV infrastructure or with IV capacity limitationsU.S. FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024Basel, 17 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from the Phase III...
Source: Roche Media News - April 17, 2024 Category: Pharmaceuticals Source Type: news

SNGX: Agreement with EMA on Second Confirmatory Trial for HyBryte ™
Reaches Agreement with European Medicines Agency on Second Confirmatory Trial for HyBryte™ On April 3, 2024, Soligenix, Inc. SNGX announced it has reached agreement with the European Medicines Agency (EMA) on the key design elements for a confirmatory Phase 3 trial of HyBryte (synthetic hypericin)…#reachesagreement #soligenixinc #phase3 #hybryte #grade1 #flash2 #fda #usfda #odd #suvax (Source: Reuters: Health)
Source: Reuters: Health - April 16, 2024 Category: Consumer Health News Source Type: news

No Link Between GLP-1 Drugs and Suicide, Says European Regulator
(MedPage Today) -- The European Medicines Agency (EMA) found no evidence to support a causal link between GLP-1 receptor agonists and suicidal thoughts, a committee said on Friday following a 9-month review. An investigation was launched in July... (Source: MedPage Today Psychiatry)
Source: MedPage Today Psychiatry - April 12, 2024 Category: Psychiatry Source Type: news

Novo Nordisk/Eli Lilly's Weight Loss Drugs Does Not Cause Suicidal Behaviors - After FDA, European Medicines Agency Says
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has determined that there is no substantial evidence supporting a link between Glucagon-Like Peptide-1 receptor agonists (GLP-1) and suicidal or self-injurious thoughts and behaviors. The assessment comes following…#glp1 #fda #obese #saxenda #xultophy #sanofisas #snylyxumia #suliqua #elilillyand #cosllytrulicity (Source: Reuters: Health)
Source: Reuters: Health - April 12, 2024 Category: Consumer Health News Source Type: news

EU to Review Weight Loss Drugs for Suicidal Thoughts Risk EU to Review Weight Loss Drugs for Suicidal Thoughts Risk
A European Medicines Agency committee will this week hold a meeting related to its probe into reports of suicidal thoughts after taking diabetes and weight loss drugs such...Reuters Health Information (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - April 8, 2024 Category: Internal Medicine Tags: Diabetes & Endocrinology Source Type: news

Roche and Alnylam present positive results from the Phase II KARDIA-2 study of zilebesiran added to standard of care antihypertensives in patients with inadequately controlled hypertension
The KARDIA-2 study met its primary endpoint demonstrating additive, placebo-adjusted systolic blood pressure reductions of up to 12.1 mmHgat month three. These results were statistically significant and clinically meaningfulZilebesiran demonstrated an encouraging safety and tolerability profile when added to standard of care antihypertensives Basel, 7 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam today released detailed results from the Phase II KARDIA-2 study evaluating the efficacy and safety of a single subcutaneous dose of zilebesiran when added to one of three standard of care (SOC) antihypertensives. T...
Source: Roche Investor Update - April 7, 2024 Category: Pharmaceuticals Source Type: news

EMA Approves Two Hybrid Medicines EMA Approves Two Hybrid Medicines
Medications to treat malignant hyperthermia and pediatric hypotension have been recommended for marketing authorization by the European Medicines Agency.Medscape Medical News (Source: Medscape Critical Care Headlines)
Source: Medscape Critical Care Headlines - March 22, 2024 Category: Intensive Care Tags: Pharmacist Source Type: news

EU Backs First Oral Monotherapy for Adults With PNH EU Backs First Oral Monotherapy for Adults With PNH
The European Medicines Agency has recommended Fabhalta for treating paroxysmal nocturnal hemoglobinuria after reviewing clinical trial results.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - March 22, 2024 Category: Drugs & Pharmacology Tags: Hematology-Oncology Source Type: news

Going Global: Bringing Drugs for Depression to Market in the US and EU, Upcoming Webinar Hosted by Xtalks
In this free webinar, gain insights into how to bring drugs for depression to market in the US and EU. Attendees will learn about the potential impact of the draft European Medicines Agency (EMA) guidance on development planning and regulatory strategy. The featured speakers will share... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - March 20, 2024 Category: Pharmaceuticals Source Type: news

Roche and Alnylam report positive topline results from the Phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care
KARDIA-2 study met its primary endpoint, demonstrating clinically significant systolic blood pressure reductions in each treatment arm at month threeZilebesiran added to a standard of care hypertension medication demonstrated an encouraging safety and tolerability profile in adults with mild to moderate uncontrolled hypertension, and results support the potential for twice-yearly dosingRoche and Alnylam have initiated the Phase II KARDIA-3 study in adults with uncontrolled hypertension at high cardiovascular riskKARDIA-2 study results will be presented as a late-breaking abstract in April at the 2024 American College of Ca...
Source: Roche Investor Update - March 5, 2024 Category: Pharmaceuticals Source Type: news

Roche and Alnylam report positive topline results from the Phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care
KARDIA-2 study met its primary endpoint, demonstrating clinically significant systolic blood pressure reductions in each treatment arm at month threeZilebesiran added to a standard of care hypertension medication demonstrated an encouraging safety and tolerability profile in adults with mild to moderate uncontrolled hypertension, and results support the potential for twice-yearly dosingRoche and Alnylam have initiated the Phase II KARDIA-3 study in adults with uncontrolled hypertension at high cardiovascular riskKARDIA-2 study results will be presented as a late-breaking abstract in April at the 2024 American College of Ca...
Source: Roche Media News - March 5, 2024 Category: Pharmaceuticals Source Type: news

New Drugs Yield Limited Benefit; Big Jump in Drug Prices; AI Boost for Mammo Results
(MedPage Today) -- Two-thirds of cancer drugs approved by the European Medicines Agency from 1995 to 2020 had little or no supporting evidence of added clinical benefit, particularly drugs that had fast-track designation. (The BMJ) Meanwhile... (Source: MedPage Today Hematology/Oncology)
Source: MedPage Today Hematology/Oncology - March 1, 2024 Category: Hematology Source Type: news

European Approval for Lung and Skin Cancer Drugs European Approval for Lung and Skin Cancer Drugs
The European Medicines Agency granted marketing authorization for tislelizumab and retifanlimab for the treatment of non –small cell lung cancer and Merkel cell carcinoma, respectively.Medscape Medical News (Source: Medscape Dermatology Headlines)
Source: Medscape Dermatology Headlines - February 23, 2024 Category: Dermatology Tags: Hematology-Oncology Source Type: news

EMA Approves Two Therapies for Rare Genetic Diseases EMA Approves Two Therapies for Rare Genetic Diseases
Treatments for amyotrophic lateral sclerosis and paroxysmal nocturnal hemoglobinuria have been given marketing authorization by the European Medicines Agency.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - February 23, 2024 Category: Cancer & Oncology Tags: Hematology-Oncology Source Type: news