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EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 March 2020

Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its March 2020 meeting. In line with EMA’s measures to limit the spread of COVID-19, the meeting was held virtually. The Committee recommended granting a conditional marketing authorisation for Zolgensma* (onasemnogene abeparvovec), an advanced therapy medicinal product (ATMP) for the treatment of babies and young children [...]

EMA: New gene therapy to treat spinal muscular atrophy

EMA has recommended granting a conditional marketing authorisation in the European Union for the gene therapy Zolgensma (onasemnogene abeparvovec) to treat babies and young children with spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. There are currently limited treatment options for children with SMA in [...]

2020-03-30T19:52:06+00:0030.03.2020|Drug Development Strategy, Regulatory Affairs|

FDA Continues to Support Transparency and Collaboration in Drug Approval Process as the Clinical Data Summary Pilot Concludes

As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more collaborative approach to our drug approval process. Today, drugs that are approved by the FDA to be marketed in the United States are developed both in and out of the United States. [...]

2020-03-27T16:18:01+00:0027.03.2020|Drug Development Strategy, Regulatory Affairs|

UK MHRA: Chloroquine and Hydroxychloroquine not licensed for coronavirus (COVID-19) treatment

Recent media reports have suggested that chloroquine can protect patients from coronavirus or treat COVID-19, the illness caused by a coronavirus. We understand these are challenging times, and patients may be worried, but we are doing everything we can to continue to ensure patient safety. Chloroquine and hydroxychloroquine are not licensed to treat COVID-19 related [...]

2020-03-26T20:36:43+00:0026.03.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Global regulators map out data requirements for phase 1 COVID-19 vaccine trials

Global regulators have published a report today presenting the outcomes of a workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting report provides an overview of regulatory considerations related to COVID-19 vaccine development and data required for regulatory decision-making on two key points: Pre-clinical [...]

2020-03-26T20:30:21+00:0026.03.2020|Drug Development Strategy, Regulatory Affairs|

Infarmed: Novo medicamento para doença renal crónica (Veltassa – Patirómero – Avaliação prévia hospitalar concluída)

O medicamento Veltassa (Patirómero) obteve autorização para ser utilizado em meio hospitalar na indicação: Tratamento da hipercaliemia em adultos com doença renal crónica estádios 3-4 sob terapêutica com inibidores do eixo renina-angiotensina-aldosterona. Concluiu-se que existe sugestão de valor terapêutico acrescentado não quantificável do patirómero em relação a cuidados padrão [que inclui dieta pobre em potássio, [...]

2020-03-25T19:54:27+00:0025.03.2020|Drug Development Strategy, Regulatory Affairs|

FDA Statement: Insulin Gains New Pathway to Increased Competition

Today is a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open [...]

2020-03-25T19:47:46+00:0025.03.2020|Drug Development Strategy, Regulatory Affairs|

FDA provides update on patient access to certain REMS drugs during COVID-19 public health emergency – Coronavirus (COVID-19) Update

Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time. “The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory [...]

2020-03-25T17:28:08+00:0025.03.2020|Drug Development Strategy, Regulatory Affairs|

UK MHRA guidance on Coronavirus (COVID-19)

The MHRA is working closely with DHSC and other healthcare partners on COVID-19. We are prioritising work including: Supporting and authorising the development of vaccines Clinical trials of new medicines Managing the supply of medicines and healthcare products We also provide information to patients, manufacturers and healthcare professionals through our established information channels and alert systems. The [...]

FDA Issues first Emergency Use Authorization for Point of Care Diagnostic – Coronavirus (COVID-19) Update

Today, the U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March [...]

2020-03-24T18:20:06+00:0024.03.2020|Drug Development Strategy, Regulatory Affairs|

ANSM: Essais cliniques: procédures accélérées pour l’évaluation des traitements du COVID-19 et recommandations aux promoteurs sur les essais en cours

L’ANSM est mobilisée auprès des équipes de recherche afin que les essais cliniques en cours se poursuivent dans les meilleures conditions, tout en continuant d’assurer la sécurité des patients. En effet, la poursuite des essais cliniques dans les hôpitaux va être perturbée en raison de la mobilisation des équipes médicales et des risques potentiels liés [...]

2020-03-24T18:12:08+00:0024.03.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to [...]

UK MHRA: Clinical trials applications for Coronavirus (COVID-19)

The MHRA is ready to prioritise and provide any assistance for clinical trials applications submitted for COVID-19 Prioritising COVID-19 assessments We have procedures for rapid scientific advice, reviews and approvals and are ready to support manufactures, researchers and other regulators. We have dedicated resources to ensure this happens, as we did during the Ebola crisis [...]

2020-03-23T17:13:21+00:0023.03.2020|Drug Development Strategy, Regulatory Affairs|

UK MHRA: Managing clinical trials during Coronavirus (COVID-19)

This guidance advises those involved in clinical trials on specific issues which may arise as a result of COVID-19, and what they are required to do. We have separate guidance on Clinical trials applications for Coronavirus (COVID-19). The MHRA will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time. [...]

2020-03-23T17:05:49+00:0023.03.2020|Drug Development Strategy, Regulatory Affairs|

WHO Pharmaceuticals Newsletter (No.1, 2020)

The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities around the world. It also provides signals based on information derived from Individual Case Safety Reports (ICSRs) available in the WHO Global ICSR database, VigiBase®. This edition of the Newsletter includes updates on [...]

FDA Continues to Facilitate Development of Treatments – Coronavirus (COVID-19) Update

The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, [...]

2020-03-22T11:32:54+00:0022.03.2020|Drug Development Strategy, Regulatory Affairs|

FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C

The U.S. Food and Drug Administration today approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis. Epclusa in combination [...]

2020-03-22T11:22:31+00:0022.03.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Call to pool research resources into large multi-centre, multi-arm clinical trials to generate sound evidence on COVID-19 treatments

EMA’s Human Medicines Committee (CHMP) has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of COVID-19. The statement promotes a harmonised approach to data collection and a robust methodology for COVID-19 clinical trials across [...]

2020-03-22T11:15:40+00:0022.03.2020|Drug Development Strategy, Regulatory Affairs|

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

The Food and Drug Administration (FDA or Agency) plays a critical role in protecting the United States from threats including emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic. FDA is issuing this guidance to provide general considerations [...]