83-200, г. Starogard Gdanski, Koteze, ул. Sokola 1, Польша
Tел./факс: (+48) 58 531 02 59
Tел: (+48) 606 93 82 51

The use of monoclonal antibodies to treat COVID-19

  • 8 февраля 2021
  • ACTEMRA, application, AstraZeneca, AZD7442, bamlanivimab, benefits, casirivimab, Celltrion, CHMP, cilgavimab, CMA, conditional marketing authorisation, COVID-19, CT-P59, EC, EEA, Eli Lilly, EMA, etesevimab, EU, Evusheld, F. Hoffman-La Roche Ltd, FDA, GlaxoSmithKline, GSK4182136, imdevimab, mAb, monoclonal antibodies, regdanvimab, Regeneron Pharmaceuticals Inc., Regkirona, REGN-COV2, risks, RoActemra, Roche, rolling review, SARS-Cov-2, sotrovimab, tixagevimab, tocilizumab, Vir Biotechnology Inc., VIR-7831,
EMA’s human medicines committee (CHMP) is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. The committee will carry out two separate reviews, one for the casirivimab/imdevimab
Читайте дальше

Vaccines against COVID-19

  • 10 декабря 2020
  • application, AstraZeneca, benefits, BioNTech, BNT162b2, ChAdOx1-SARS-CoV-2, CHMP, CMA, conditional marketing authorisation, COVID-19, COVID-19 Janssen, COVID-19 Vaccine (inactivated adjuvanted), COVID-19 Vaccine Janssen, CVST, DIC, EC, EEA, EMA, EU, FDA, Gam-COVID-Vac, Gamaleya National Centre of Epidemiology and Microbiology, Janssen-Cilag International N.V., Jcovden, MHRA, Moderna Biotech Spain S.L., mRNA, mRNA-1273, Novavax CZ a.s., Nuvaxovid, Oxford University, Pfizer, R-Pharm Germany GmbH, risks, rolling review, Russia, Sanofi Pasteur, SARS-Cov-2, Spikevax, Sputnik V, vaccine, Valneva, Vaxzevria, VidPrevtyn Beta,
Comirnaty (BNT162b2) (BioNTech and Pfizer) Spikevax (mRNA-1273) (Moderna Biotech Spain, S.L.) Vaxzevria (AstraZeneca/Oxford University) Jcovden (COVID-19 Vaccine Janssen) (Janssen-Cilag International N.V.) Nuvaxovid (Novavax CZ, a.s.) COVID-19 Vaccine (inactivated, adjuvanted) (Valneva) VidPrevtyn Beta (Sanofi Pasteur) Sputnik V (Gam-COVID-Vac) (Gamaleya National Centre of Epidemiology and Microbiology, Russia)     EXTENSION OF INDICATION Update [25/11/2021] EMA’s human medicines
Читайте дальше

How to demonstrate comparability for ATMPs?

  • 18 мая 2020
  • advice, API, approach, ATIMP, ATMP, change, CHMP, clinical, comparability, data, development, drug product, drug substance, efficacy, EMA, exercise, final, finished, GMP, manufacturing, methodology, non-clinical, pivotal, process, product, profile, program, quality, RBA, risk-based, safety, scientific, site, stability, stage, statistical, studies, transfer,
  CHMP scientific advice questions are often related to the suitability of comparability proposals following changes to ATMP manufacturing processes or due to introduction of additional manufacturing sites. Manufacturing process changes may encompass improvements/change in Such changes are frequent, especially in the early stages of development of ATMPs. A suitable comparability program is required to
Читайте дальше

EU GMP Guide – Annex 21: Importation of medicinal products

  • 23 апреля 2020
  • Annex 21, GMP, IMP, import, investigational medicinal product, medicinal products, QP, QP certification, QP confirmation,
Update [21/03/2022] On 21 February 2022, the European Commission (EC) has published a final version of the new Annex 21: Importation of medicinal products of the EU GMP Guide. This new annex comes into operation on 21 August 2022.   Update Due to the challenges posed by COVID-19, the timeline for the targeted consultation has
Читайте дальше

Medical Devices Regulation

  • 21 апреля 2020
  • Медицинские устройства, Регламент (ЕС) 2017/745,
On 3 April 2020, the European Commission has adopted a proposal, to postpone by one year the date of application of the Medical Devices Regulation to allow Member States, health institutions and economic operators to prioritise the fight against the coronavirus pandemic. This proposal therefore postpones, for exceptional reasons in the current context, the application
Читайте дальше

First non-injectable treatment for severe hypoglycaemia!

  • 30 октября 2019
  • administration, Baqsimi, centralised procedure, CHMP, CP, demonstration, device, diabetes, dispenser, Eli Lilly Nederland B.V., EMA, EU, formulation, glucagon, glucose, hypoglycaemia, instructional, insulin, kit, leaflet, low blood sugar level, MA, MAH, marketing authorization, measures, medicinal product, minimization, nasal powder, non-injectable, novel, pharmaceutical, risk, severe, single-use, training, treatment, video,
On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation in the European Union for the medicinal product Baqsimi, intended for the treatment of severe hypoglycaemia. It is the first treatment for severe hypoglycaemia (low blood sugar levels) that can be
Читайте дальше

“Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products (ATIMPs) in clinical trials” in the consultation phase

  • 8 июля 2019
  • analysis, animal, ATIMP, ATMP, cell, clinical, confirmatory, CT, CTD, development, dossier, early, editing, efficacy, EMA, exploratory, FIH, FIM, gene, genetic, genome, guideline, healthy, IMP, IMPD, late, MA, manipulation, manufacturing, model, modification, Module 3, multidisciplinary, non-cellular, non-clinical, patient, phase, population, protocol, QC, quality, quality control, requirements, risk, safety, study, subject, trial, type, vector, volunteer,
On 21 February 2019, the European Medicines Agency (EMA) has published the draft Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials. The public consultation phase will last until 1 August 2019. The main objective of this guideline is to avoid discrepancies across the EU regarding the requirements
Читайте дальше

Omega-3 fatty acid medicines are not effective in preventing further heart problems after a heart attack!

  • 25 июня 2019
  • benefit, benefit-risk balance, blood vessels, clinical, CT, DHA, effective, EPA, fish oils, heart attack, heart problems, hypertriglyceridaemia, indication, MA, marketing authorisation, medicinal product, medicines, MI, myocardial infarction, not, Omacor, Omega-3 fatty acid, open-label study, oral use, PI, preventing, product information, re-examination, reference, scientific conclusions, secondary prevention, supplementation, treatment, trials, variation,
On 29 March 2019 EMA confirmed that omega-3 fatty acid medicines containing a combination of an ethyl ester of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) – EPA and DHA are commonly found in fish oils – at a dose of 1 g per day are not effective in preventing further problems with the heart
Читайте дальше

Brexit and EU rules in the field of clinical trials (CTs)

  • 5 марта 2019
  • Brexit, clinical trials, CT, database, EC, EudraCT, IMP, import, investigational medicinal product, legal consequences, notice, sponsor, UK's withdrawal,
In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, sponsors (both academic researchers and pharmaceutical companies) conducting or planning to conduct clinical trials, as well as investigators and other persons involved in the preparation and conduct of clinical trials in the EU are reminded of legal repercussions, which
Читайте дальше