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New long-term data for Roche ’s Vabysmo show sustained retinal drying and vision improvements in retinal vein occlusion (RVO)
Vabysmo sustained robust drying of retinal fluid, often associated with distorted or blurry visionUp to 60% of people receiving Vabysmo were able to extend treatment intervals to three or four months apartDetailed results from two global Phase III RVO studies will be presented at Angiogenesis, Exudation, and Degeneration 2024Vabysmo is approved in the US for RVO, and in more than 90 countries around the world for people living with nAMD and DMEBasel, 1 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new 72-week data from two global Phase III studies, BALATON and COMINO, evaluating Vabysmo® (faricimab) i...
Source: Roche Media News - February 1, 2024 Category: Pharmaceuticals Source Type: news

Glenmark partners with Pfizer to launch abrocitinib in India to treat atopic dermatitis
Glenmark and Pfizer will co-market abrocitinib in India under the brand names JABRYUS and CIBINQO. Developed by Pfizer, abrocitinib has received marketing authorization for abrocitinib in adults with moderate-to-severe atopic dermatitis from the Central Drugs Standard Control Organization (CDSCO). It is also approved by the USFDA, European Medicines Agency (EMA), and other regulatory agencies. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 31, 2024 Category: Pharmaceuticals Source Type: news

FDA Enhances Global Patient and Regulatory Collaborations in Oncology
In recognition of World Cancer Day 2024, the FDA and European Medicines Agency will collaborate to spotlight innovative cancer treatment advances for patients. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 30, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Orchid Pharma's new antibiotic 'Exblifeb' gets European Medicines Agency approval
The Chennai-based firm said Exblifeb incorporates Enmetazobactam, "the first completely invented-in-India Beta Lactamase inhibitor" and it is designed to address the global challenge of antimicrobial resistance (AMR). Exblifeb' demonstrates remarkable efficacy in treating complicated urinary tract infections (UTI), pneumonia, and bacteremia caused by extended spectrum beta-lactamase producing pathogens, Orchid Pharma said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 30, 2024 Category: Pharmaceuticals Source Type: news

Europe Approves Exblifep for UTIs and Pneumonia Europe Approves Exblifep for UTIs and Pneumonia
Exblifep is as effective as piperacillin-tazobactam in the treatment of complicated urinary tract infections, the European Medicines Agency said.Medscape Medical News (Source: Medscape Pharmacist Headlines)
Source: Medscape Pharmacist Headlines - January 26, 2024 Category: Drugs & Pharmacology Tags: Urology Source Type: news

European Commission approves Roche ’s Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to intravenous (IV) infusion and is preferred by cancer patients, nurses and physicians1-5Tecentriq SC reduces treatment time by approximately 80%, compared with standard IV infusion6Roche is working closely with national health systems in Europe to ensure patients can access Tecentriq SC as quickly as possibleBasel, 16 January 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for Tecentriq ® SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer...
Source: Roche Investor Update - January 16, 2024 Category: Pharmaceuticals Source Type: news

European Commission approves Roche ’s Tecentriq SC, the EU's first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types
Subcutaneous (SC) injection offers the potential for a faster, more convenient alternative to intravenous (IV) infusion and is preferred by cancer patients, nurses and physicians1-5Tecentriq SC reduces treatment time by approximately 80%, compared with standard IV infusion6Roche is working closely with national health systems in Europe to ensure patients can access Tecentriq SC as quickly as possibleBasel, 16 January 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for Tecentriq ® SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer...
Source: Roche Media News - January 16, 2024 Category: Pharmaceuticals Source Type: news

Europe Tightens Valproate Treatment Rules Europe Tightens Valproate Treatment Rules
Precautionary measures from the European Medicines Agency aim to prevent neurodevelopmental disorders in children born to men treated with valproate prior to conception.Medscape Medical News (Source: Medscape Internal Medicine Headlines)
Source: Medscape Internal Medicine Headlines - January 12, 2024 Category: Internal Medicine Tags: Pharmacist Source Type: news

European Medicines Agency & FDA Questions & Answers: Expediting Quality Development for FDA ’s Breakthrough Therapies and EMA's PRIME Programs
FDA and the European Medicines Agency (EMA) published the “EMA–FDA joint Q&As on Quality and GMP aspects of PRIME/Breakthrough therapy applications ” document supporting quality development for FDA’s Breakthrough Therapy (BT) designation and EMA’s Priority Medicines (PRIME) scheme programs (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - December 19, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Safety alert over medical-grade omega-3 pills: EU health chiefs warn certain capsules may raise the risk of irregular heartbeat
European Medicines Agency (EMA) chiefs now say an irregular heartbeat side effect is 'common' after reviewing decades of evidence. (Source: the Mail online | Health)
Source: the Mail online | Health - December 8, 2023 Category: Consumer Health News Source Type: news

Ipsen Confirms U.S. FDA Grants Priority Review for New Drug Application for Elafibranor for the Treatment of Rare Cholestatic Liver Disease, PBC
New Drug Application granted priority review with PDUFA date set for June 10, 2024 European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor Investigational elafibranor is the first novel... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2023 Category: Drugs & Pharmacology Source Type: news

EMA Committee Recommends Label Update for Some Decongestants EMA Committee Recommends Label Update for Some Decongestants
The European Medicines Agency ' s safety committee on Friday recommended changes to product information for all medicines that contain the ingredient pseudoephedrine to address safety concerns related to neurological and heart-related side effects.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 4, 2023 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

Regulators are looking into whether weight-loss drugs like Ozempic raise the risk of suicidal thoughts
The European Union’s drugs regulator has asked pharma companies including Novo Nordisk A/S and Eli Lilly & Co. for more information as it reviews the potential risk of suicidal thoughts associated with a new class of weight-loss medicines. The European Medicines Agency started investigating the…#europeanunions #novonordiskas #elilillyco #glp1 #novoswegovy #pharma #ema #lilly #trulicity #astrazenecaplcs (Source: Reuters: Health)
Source: Reuters: Health - December 2, 2023 Category: Consumer Health News Source Type: news

Autolus Therapeutics Submits Biologics License Application to U.S. Food and Drug Administration for obecabtagene autoleucel (obe-cel) for Patients with …
Company on track to submit a marketing authorization application to the European Medicines Agency (EMA) in the first half of 2024 LONDON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Autolus Therapeutics plc AUTL, a clinical-stage biopharmaceutical company developing next-generation programmed T cell…#ema #fda #bla #pivotalphase2 #sandiego #christianitin #auto1 #felix #ucl #phaseii (Source: Reuters: Health)
Source: Reuters: Health - November 27, 2023 Category: Consumer Health News Source Type: news

Roche ’s subcutaneous injection of Tecentriq recommended by the EU’s CHMP for multiple cancer types
If approved, Tecentriq subcutaneous (SC) would be the first injectable PD-(L)1 cancer immunotherapy in the EU, cutting treatment time by approx. 80%1 The CHMP recommended Tecentriq SC for all indications of intravenous (IV) Tecentriq, including certain types of lung, liver, bladder and breast cancer2A majority of healthcare professionals surveyed in the IMscin001 study found that the SC formulation is easy to administer and could save time compared with IV1Basel, 14 November 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (C...
Source: Roche Investor Update - November 14, 2023 Category: Pharmaceuticals Source Type: news