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FDA Approves New HIV Treatment for Patients With Limited Treatment Options

Today, the U.S. Food and Drug Administration approved Rukobia (fostemsavir), a new type of antiretroviral medication for adults living with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations. “This approval marks a new class of antiretroviral medications that [...]

2020-07-10T18:59:12+00:0010.07.2020|Drug Development Strategy, Regulatory Affairs|

Infarmed: Utilização de medicamentos para COVID-19 – remdesivir

O medicamento remdesivir obteve um parecer positivo do Comité de Medicamentos de Uso Humano (CHMP) da Agência Europeia de Medicamentos (EMA), cuja autorização deverá ser concedida em breve pela Comissão Europeia. Esta autorização será condicional por ainda se aguardarem resultados confirmatórios. Este medicamento esteve sempre disponível em Portugal, mesmo antes de ter a referida autorização [...]

2020-07-10T18:51:27+00:0010.07.2020|Regulatory Affairs|

EMA: International regulators provide guiding principles for COVID-19 clinical trials

EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Medicines regulators from around the world have jointly developed this statement to step up global collaboration to facilitate and expedite the development and evaluation of therapeutics, diagnostics and vaccines against COVID-19. “As the COVID-19 pandemic [...]

2020-07-08T20:58:38+00:0008.07.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de abril 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 [...]

FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines

Today, the U.S. Food and Drug Administration took important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines for the ultimate purpose of licensure. The guidance, which reflects advice the FDA has been providing over the past several months to companies, [...]

2020-07-08T20:47:56+00:0008.07.2020|Drug Development Strategy, Regulatory Affairs|

FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer

Today, the U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also [...]

2020-07-08T20:43:02+00:0008.07.2020|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 [...]

2020-07-06T21:12:19+00:0006.07.2020|Regulatory Affairs|

UK MHRA: Green light for COVID-19 trial recruitment

The MHRA has approved the recruitment of further participants for a clinical trial by the University of Oxford The MHRA has approved the recruitment of further participants for a clinical trial investigating hydroxychloroquine in prevention of COVID-19, by the University of Oxford. Dr Siu Ping Lam, Director of Licensing at the MHRA, said: We have [...]

2020-07-06T21:06:43+00:0006.07.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020

Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its June 2020 meeting. The Committee recommended granting a conditional marketing authorisation for Veklury (remdesivir), for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 [...]

EMA: New medicine for cystic fibrosis patients

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Kaftrio, the first triple combination therapy for the treatment of cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a [...]

2020-07-03T21:00:13+00:0003.07.2020|Drug Development Strategy, Regulatory Affairs|

EMA: New treatment to enable kidney transplant in highly sensitised patients

EMA has recommended granting a conditional marketing authorisation in the European Union for Idefirix (imlifidase), the first treatment for adult patients waiting for a kidney transplant, who are highly sensitised against tissue from the donor and who have a positive crossmatch test against an available kidney from a deceased donor. Idefirix should be used complementary to existing [...]

2020-07-03T20:49:27+00:0003.07.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: La EMA emite recomendación positiva para autorización de comercialización condicional del primer tratamiento para 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. En España, remdesivir se ha estado utilizado para tratamiento de la COVID-19 en el contexto de ensayos clínicos y en el [...]

2020-07-01T19:58:59+00:0001.07.2020|Regulatory Affairs|

FDA Approves New Therapy for Dravet Syndrome

The U.S. Food and Drug Administration today approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures despite medical treatment. “Dravet syndrome is a [...]

2020-07-01T19:50:06+00:0001.07.2020|Drug Development Strategy, Regulatory Affairs|

EMA: First COVID-19 treatment recommended for EU authorisation

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. Data on remdesivir were assessed in an [...]

2020-07-01T19:46:17+00:0001.07.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Global regulators discuss data requirements for phase 3 trials of COVID-19 vaccines

Under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators discussed COVID-19 vaccine development and the necessary evidence required for regulatory decision-making at the second regulatory workshop on COVID-19 vaccines. The meeting was jointly organised by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on 22 June 2020. [...]

2020-07-01T19:40:19+00:0001.07.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) La AEMPS toma medidas con respecto a los ensayos clínicos para la COVID-19 con hidroxicloroquina

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. Varios ensayos clínicos ya han ofrecido resultados acerca de la eficacia de la hidroxicloroquina para el tratamiento de la COVID-19. Ante [...]

2020-06-26T21:28:36+00:0026.06.2020|Pharmacovigilance, Regulatory Affairs|

(Cas) La AEMPS informa de los medicamentos sobre los que se deberá seguir informando periódicamente como medida de precaución ante posibles rebrotes

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. Se establece un listado de medicamentos para los cuales los TACs deberán seguir informando semanalmente sus ventas, stocks y previsiones. Esta [...]

2020-06-26T21:22:56+00:0026.06.2020|Regulatory Affairs|

EMA: European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines

Senior officials from the European Commission (EC - DG SANTE), EMA and the United States Food and Drug Administration (FDA) held their 2020 bilateral regulatory dialogue meeting on 18 and 19 June. During this virtual two-day meeting, the authorities reviewed their ongoing joint initiatives, discussed strategic priorities for the coming years and identified areas where [...]

2020-06-26T21:16:44+00:0026.06.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Información a los Laboratorios Titulares de Medicamentos de Uso Humano que contienen la sustancia activa ‘FOSFOMICINA’

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. Este organismo informa de la publicación de la Decisión de Ejecución de la Comisión C(2020) 3966 final, de fecha 09/06/2020, de [...]

2020-06-25T21:46:58+00:0025.06.2020|Regulatory Affairs|