> Drug Development Strategy

Infarmed: Novo medicamento para adultos diabéticos (Tresiba – Insulina degludec – Avaliação da comparticipação concluída)

O medicamento Tresiba (Insulina degludec) obteve autorização de comparticipação na indicação: Tratamento da diabetes mellitus tipo 1, em adultos. Na fase de avaliação farmacoterapêutica o medicamento Tresiba (insulina degludec) apresentou valor terapêutico acrescentado não quantificável em relação à insulina glargina, na população de doentes adultos com DM tipo 1. Na avaliação económica, os valores custo-efetividade [...]

2019-05-24T19:50:46+00:0025.05.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Update of EU recommendations for 2019–2020 seasonal flu vaccine composition

EMA has issued an  update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2019. The recommendations now also contain a decision on suitable H1N1 and H3N2 viruses for seasonal live attenuated influenza vaccines (LAIV). The list of reagents for vaccine standardisation [...]

2019-05-24T21:34:01+00:0024.05.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots

The U.S. Food and Drug Administration today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the [...]

2019-05-21T20:48:54+00:0021.05.2019|Drug Development Strategy, Regulatory Affairs|

Infarmed publica estudo sobre anti-histamínicos

Um anti-histamínico é um fármaco que é normalmente utilizado para alivio de alergias no tratamento de reações de hipersensibilidade. O estudo agora publicado revela que a utilização de anti-histamínicos aumentou durante todo o período de análise apresentado. Apesar de se observar um ligeiro decréscimo em 2017, em 2018 voltou a aumentar, atingindo 6,3 milhões de [...]

2019-05-12T14:39:42+00:0012.05.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age. This is the first FDA approval of a treatment specifically for pediatric patients with LEMS. The only other treatment approved for LEMS is only approved for [...]

2019-05-08T20:26:33+00:0008.05.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin mediated amyloidosis

On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Vyndaqel and Vyndamax have the same active moiety, tafamidis, but they are not substitutable [...]

2019-05-08T20:14:32+00:0008.05.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Avis et recommandations du Comité des médicaments pédiatriques (PDCO) de l’Agence européenne des médicaments (EMA) – Réunion du 26 – 29 Mars 2019

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 [...]

2019-05-08T20:05:45+00:0008.05.2019|Drug Development Strategy, Regulatory Affairs|

FDA: First FDA-approved vaccine for the prevention of dengue disease in endemic regions

The U.S. Food and Drug Administration announced today the approval of Dengvaxia, the first vaccine approved for the prevention of dengue disease caused by all dengue virus serotypes (1, 2, 3 and 4) in people ages 9 through 16 who have laboratory-confirmed previous dengue infection and who live in endemic areas. Dengue is endemic in [...]

2019-05-07T20:05:30+00:0007.05.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín trimestral de la AEMPS sobre productos sanitarios y cosméticos Enero – Marzo 2019

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 información sobre la evolución de la legislación de estos productos, los documentos técnicos y científicos publicados, las actuaciones de vigilancia y [...]

FDA approves first treatment for all genotypes of hepatitis C in pediatric patients

The U.S. Food and Drug Administration today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of hepatitis C virus (HCV) in children ages 12 to 17. Mavyret was previously approved to treat HCV in adults in 2017. “Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from [...]

2019-05-07T19:43:56+00:0007.05.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de marzo de 2019

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 approves device to help increase access to more lungs for transplant

The U.S. Food and Drug Administration today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can temporarily ventilate, oxygenate, and pump (perfuse) preservation solution through lungs that were initially thought to be unacceptable for transplant. The device allows the transplant team to perform a more careful assessment of lung function to [...]

2019-05-02T15:14:34+00:0002.05.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first treatment for pediatric patients with lupus

The U.S. Food and Drug Administration today approved Benlysta (belimumab) intravenous (IV) infusion for treatment of children with systemic lupus erythematosus (SLE) – often referred to as simply “lupus” – a serious chronic disease that causes inflammation and damage to various body tissues and organs. This is the first time that the FDA has approved [...]

2019-05-02T15:11:56+00:0002.05.2019|Drug Development Strategy, Regulatory Affairs|

EMA: New long-lasting implant to treat opioid dependence

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union (EU) for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months. It is indicated in clinically stable adult patients who require no more than 8 [...]

2019-05-02T14:02:37+00:0002.05.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019

EMA’s human medicines committee (CHMP) recommended thirteen medicines for approval at its April 2019 meeting. The Committee recommended granting a marketing authorisation for Sixmo (buprenorphine) as a substitution treatment for opioid dependence. Sixmo is an implant that releases low levels of buprenorphine into the patient’s body for six months. Two orphan medicines received a positive opinion from the CHMP: Esperoct (turoctocog alfa pegol), for [...]

EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo

EMA has completed its assessment of the results of the ANNOUNCE study and concluded that Lartruvo (olaratumab) with doxorubicin does not prolong the lives of patients with soft tissue cancer more than doxorubicin alone. The Agency is therefore recommending that the marketing authorisation of the medicine be revoked. In January 2019, when preliminary results of the ANNOUNCE study [...]

2019-05-02T13:33:20+00:0002.05.2019|Drug Development Strategy, Pharmacovigilance|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de febrero de 2019

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 permits marketing of first medical device for treatment of ADHD

The U.S. Food and Drug Administration today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder (ADHD). The prescription-only device, called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, is indicated for patients ages 7 to12 years old who are not currently taking prescription ADHD medication and is the first non-drug [...]

2019-04-26T17:31:57+00:0026.04.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first generic naloxone nasal spray to treat opioid overdose

The U.S. Food and Drug Administration today granted final approval of the first generic naloxone hydrochloride nasal spray, commonly known as Narcan, a life-saving medication that can stop or reverse the effects of an opioid overdose. The agency is also planning new steps to prioritize the review of additional generic drug applications for products intended [...]

2019-04-26T17:28:38+00:0026.04.2019|Drug Development Strategy, Regulatory Affairs|