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(Cas) AEMPS: Boletín mensual de seguridad de la AEMPS sobre medicamentos de uso humano del mes de noviembre de 2020

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Recoge nuevos medicamentos, cambios de especial interés en medicamentos ya autorizados, información sobre seguridad y otra información de interés. En la sección [...]

EMA: Human medicines: highlights of 2020

EMA has published an overview of its key recommendations in 2020 on the authorisation and safety monitoring of medicines for human use. In 2020, EMA recommended 97 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union before. The Agency recommended one vaccine and one treatment for COVID-19, and [...]

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

The U.S. Food and Drug Administration today approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and [...]

2021-01-24T19:53:33+00:0024.01.2021|Drug Development Strategy, Regulatory Affairs|

EMA: Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines

EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe, effective and high-quality COVID-19 vaccines. ‘Healthcare professionals are the heroes of this pandemic,’ said Emer Cooke, Chair of ICMRA and EMA’s Executive Director. ‘We [...]

(Cas) AEMPS: Actualización de la situación de los medicamentos de uso humano y veterinario a consecuencia del brexit

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Tras el abandono de Reino Unido de la UE, el período de transición también se ha dado por finalizado a 31 [...]

(Cas) AEMPS: La EMA recibe la solicitud de autorización condicional de la vacuna frente la COVID-19 de AstraZeneca

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. La evaluación de los datos ya comenzó el pasado 1 de octubre a través del llamado rolling review, un mecanismo excepcional por el [...]

2021-01-16T13:58:46+00:0016.01.2021|Drug Development Strategy, Regulatory Affairs|

Infarmed: Horizon Scanning – Nova plataforma de submissão de informação

Dando continuidade ao projeto de Horizon Scanning iniciado em 2018, é com satisfação que o Infarmed comunica o lançamento de uma plataforma para recolha desta informação. Este projeto permitiu agregar informação relativa à introdução de novas tecnologias no Serviço Nacional de Saúde, viabilizando um melhor planeamento das atividades do Infarmed nesta área e contribuindo para a eficiência [...]

2021-01-16T13:55:29+00:0016.01.2021|Drug Development Strategy, Regulatory Affairs|

EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca

EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided [...]

2021-01-12T19:48:04+00:0012.01.2021|Drug Development Strategy, Regulatory Affairs|

UK MHRA: Moderna vaccine becomes third COVID-19 vaccine approved by UK regulator

The vaccine has been approved after meeting the required safety, quality and effectiveness standards. The COVID-19 vaccine developed by Moderna has today been given regulatory approval for supply by the Medicines and Healthcare products Regulatory Agency (MHRA). This follows a thorough and rigorous assessment by the MHRA’s teams of scientists, including advice from the independent Commission on [...]

2021-01-10T11:01:04+00:0010.01.2021|Drug Development Strategy, Regulatory Affairs|

ANSM: Avis de l’ANSM concernant la seconde dose du vaccin Comirnaty de Pfizer-BioNtech

Dans un contexte européen de déploiement de la campagne de vaccination contre la Covid-19, plusieurs états se mobilisent pour accélérer l’accès aux vaccins, notamment pour les personnes les plus fragiles. C’est dans ce contexte que l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) donne un avis concernant la seconde dose du [...]

2021-01-08T12:29:20+00:0008.01.2021|Drug Development Strategy, Regulatory Affairs|

Infarmed: EMA dá parecer positivo a segunda vacina COVID-19 na UE

A Agência Europeia de Medicamentos (EMA, na sigla em inglês) recomendou a concessão de uma autorização de introdução no mercado condicional para a vacina do laboratório Moderna, para prevenir a doença COVID-19 em pessoas a partir dos 18 anos de idade. Esta é a segunda vacina COVID-19 que a EMA recomenda para autorização. Comunicado de [...]

2021-01-08T12:13:12+00:0008.01.2021|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: La EMA recomienda la autorización de la segunda vacuna frente a la COVID-19

Sorry, this entry is only available in European Spanish. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language. Esta vacuna, desarrollada por Moderna, previene la enfermedad causada por SARS-CoV-2 en personas a partir de los 16 años El CHMP, [...]

2021-01-07T16:15:22+00:0007.01.2021|Drug Development Strategy, Regulatory Affairs|

EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU

EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation. EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be [...]

2021-01-07T16:07:51+00:0007.01.2021|Drug Development Strategy, Regulatory Affairs|

FDA Takes Steps to Provide Clarity on Developing New Drug Products in the Age of Individualized Medicine

Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the [...]

2021-01-05T18:01:18+00:0005.01.2021|Drug Development Strategy|

The MHRA Innovative Licensing and Access Pathway is open for business

The Medicines and Healthcare products Regulatory Agency (MHRA) today, 1 January 2021, formally starts the Innovative Licensing and Access Pathway (ILAP). The ambition of this new licensing and access pathway is to reduce the time to market for innovative medicines. The ILAP combines the MHRA’s globally recognised strengths of independence and high standards of quality, safety, and efficacy, [...]

2021-01-04T15:11:13+00:0004.01.2021|Drug Development Strategy, Regulatory Affairs|

EMA: Update on rolling review of AstraZeneca’s COVID-19 vaccine

EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing over the past weeks. The Agency is currently assessing data on the vaccine as part of a rolling review. So far, some evidence has been assessed on safety and efficacy coming from a pooled analysis of interim clinical data from four ongoing clinical [...]

Infarmed: Pneumovax 23 (vacina pneumocócica poliosídica) – Avaliação da comparticipação concluída

O medicamento Pneumovax 23 (vacina pneumocócica poliosídica) obteve autorização de comparticipação na indicação: Imunização ativa contra a doença causada pelos serotipos pneumocócicos incluídos na vacina. A vacina é recomendada para indivíduos com idade igual ou superior a dois anos, nos quais existe um maior risco de morbilidade e mortalidade devido a doença pneumocócica. Os grupos [...]

2020-12-31T12:12:02+00:0031.12.2020|Drug Development Strategy, Regulatory Affairs|

FDA Approves First Generic of Drug Used to Treat Severe Hypoglycemia

Today, the U.S. Food and Drug Administration approved the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia (very low blood sugar), which may occur in patients with diabetes mellitus. The drug is also indicated as a diagnostic aid in the radiologic examination of [...]

2020-12-31T12:04:55+00:0031.12.2020|Drug Development Strategy, Regulatory Affairs|

UK MHRA: Oxford University/AstraZeneca COVID-19 vaccine approved

The new vaccine has been approved after meeting the required safety, quality and effectiveness standards. The COVID-19 vaccine developed by Oxford University/AstraZeneca has today been given regulatory approval by the Medicines and Healthcare products Regulatory Agency (MHRA) after meeting required safety, quality and effectiveness standards. Following a rigorous, detailed scientific review by the MHRA’s expert [...]

2020-12-31T09:55:56+00:0031.12.2020|Drug Development Strategy, Regulatory Affairs|