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(Eng) WHO Pharmaceuticals Newsletter (No.2, 2020)

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.This edition of the Newsletter also includes the recommendations from the 42nd Annual Meeting of Representatives of National Pharmacovigilance Centres participating [...]

(Eng) FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.The U.S. Food and Drug Administration has authorized an at-home sample collection kit that can then be sent to specified laboratories [...]

(Eng) FDA Approves First Drug for Fourth-Line Treatment of Advanced Gastrointestinal Stromal Tumors

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.Today, the U.S. Food and Drug Administration approved Qinlock (ripretinib) tablets as the first new drug specifically approved as a fourth-line [...]

(Eng) EMA: International coordination needed to encourage conduct of large, decision-relevant COVID-19 clinical trials

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of adequately powered, randomised controlled trials, [...]

(Eng) EMA: Update of EU recommendations for 2020/2021 seasonal flu vaccine composition

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.EMA has issued an update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the [...]

Infarmed: Medidas excecionais no âmbito da realização de Ensaios Clínicos durante o período de risco para a saúde pública – versão 3

Na sequência de emergência de Saúde Pública de âmbito Internacional declarada pela Organização Mundial de Saúde em 30/01/2020 para infeção por SARS-CoV-2 (novo coronavírus 2019), no que se refere à realização de ensaios clínicos em Portugal, o Infarmed admite que promotores, centros de ensaio clínico e equipas de investigação considerem necessária a introdução de alterações [...]

(Eng) FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19 – Coronavirus (COVID-19) Update

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.Today, the U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options for [...]

(Eng) FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients – Coronavirus (COVID-19) Update

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.The U.S. Food and Drug Administration has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category [...]

(Eng) FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens – Coronavirus (COVID-19) Update

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.Today, the U.S. Food and Drug Administration authorized the first diagnostic test with the option of using home-collected saliva samples for [...]

(Eng) FDA Approves First Therapy for Patients with Lung and Thyroid Cancers with a Certain Genetic Mutation or Fusion

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.Today, the U.S. Food and Drug Administration approved Retevmo (selpercatinib) capsules to treat three types of tumors – non-small cell lung [...]

ANSM: Avis et recommandations du Comité des médicaments pédiatriques (PDCO) de l’Agence européenne des médicaments (EMA) – Réunion du 24-27 Mars 2020

Ce Comité est chargé notamment de l’évaluation des PIPs (Plans d’Investigations Pédiatriques) qui encadrent les programmes de développement en qualité préclinique et clinique des médicaments destinés à la population pédiatrique (de la naissance à 17 ans inclus), ainsi que des dérogations et reports de développement en pédiatrie. Le PDCO vérifie la réalisation du programme d’études [...]

(Eng) UK MHRA: New reagent available to support global diagnostic testing of coronavirus (COVID-19)

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.A new biological reagent is now available to labs around the UK and the world that will help them to set [...]

(Eng) FDA Approves First Targeted Therapy to Treat Aggressive Form of Lung Cancer

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.Today, the U.S. Food and Drug Administration approved Tabrecta (capmatinib) for the treatment of adult patients with non-small cell lung cancer [...]

AEMPS: Actuaciones de la AEMPS para agilizar y fomentar los ensayos clínicos y estudios observacionales sobre COVID-19

Los investigadores deben considerar la posibilidad de sumarse a estudios clínicos que ya estén en marcha antes de plantear un estudio propio Se prioriza la evaluación de ensayos clínicos en COVID-19 Los estudios observacionales de seguimiento prospectivo sin ánimo comercial serán clasificados como EPA-AS Los estudios clínicos son una herramienta indispensable para poder identificar la [...]

(Eng) FDA approves new treatment for a type of heart failure

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.Today, the U.S. Food and Drug Administration approved Farxiga (dapagliflozin) oral tablets for adults with heart failure with reduced ejection fraction [...]

(Eng) EMA: Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), [...]

(Eng) EMA COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. 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.As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate [...]