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ANSM: Avis et recommandations du Comité des médicaments pédiatriques (PDCO) de l’Agence européenne des médicaments (EMA)

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 pédi1atrie. Le PDCO vérifie la réalisation du programme d’études [...]

2020-09-25T12:45:54+00:0025.09.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020

Seven new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting. The CHMP adopted a positive opinion for Exparel (bupivacaine), for the treatment of post-operative pain. The Committee recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria [...]

EMA: New oral treatment for moderate to severe atopic dermatitis

EMA has recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Olumiant is already approved in the European Union to treat moderate to severe active rheumatoid arthritis, a disease causing inflammation of the joints. Atopic dermatitis (also known [...]

2020-09-25T09:30:45+00:0025.09.2020|Drug Development Strategy, Regulatory Affairs|

EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation

EMA’s human medicines committee (CHMP) has completed its review of results from the RECOVERY study arm that involved the use of the corticosteroid medicine dexamethasone in the treatment of patients with COVID-19 admitted to hospital, and has concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy (from supplemental oxygen to mechanical [...]

2020-09-24T15:21:41+00:0024.09.2020|Drug Development Strategy|

EMA: First treatment for rare metabolic disorder alkaptonuria

EMA has recommended granting an extension of indication to Orfadin (nitisinone) to include the treatment of alkaptonuria in adult patients. This rare disorder affects one in every 250,000 to 1 million people and is more common in certain areas of Slovakia. It is characterised by the inability of the body to metabolize homogentisic acid (HGA) due to [...]

2020-09-24T15:17:10+00:0024.09.2020|Drug Development Strategy, Regulatory Affairs|

EMA: New treatment for children with chronic kidney disease

EMA has recommended granting an extension of indication for Velphoro (sucroferric oxyhydroxide) to include control of serum phosphorus levels in children aged 2 years or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia (high blood phosphate levels), which, [...]

2020-09-24T11:41:38+00:0024.09.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: España, escogida de nuevo para producir la vacuna contra 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. La biotecnológica estadounidense Novavax anuncia que un grupo biofarmacéutico español llevará a cabo la producción industrial de su vacuna en España [...]

2020-09-22T20:34:54+00:0022.09.2020|Drug Development Strategy|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de julio 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: Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21

The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies (HMA) has published its workplan  which sets actions to be delivered in 2020-21. With the European Medicines Regulatory Network focused on the response to the COVID-19 pandemic, the workplan aims to progress evolution to data-driven regulation through smart working, leveraging collaboration with stakeholders and the use [...]

2020-09-16T19:35:49+00:0016.09.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August – 3 September 2020

PRAC recommends revoking marketing authorisation of ulipristal acetate for uterine fibroids EMA’s safety committee (PRAC) recommended the revocation of the marketing authorisations of 5-mg ulipristal acetate (Esmya and generic medicines) used for the treatment of symptoms of uterine fibroids, as a review carried out by the committee confirmed liver injury, including the need for liver transplantation, caused by [...]

EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19

EMA has started evaluating an application for the authorisation of Dexamethasone Taw for treating hospitalised adult patients with COVID-19. The application, from Taw Pharma, will be evaluated by EMA’s human medicines committee (CHMP) according to an accelerated assessment timetable. This will enable the CHMP to issue an opinion on the benefits and risks of Dexamethasone Taw within the shortest [...]

2020-09-07T21:42:17+00:0007.09.2020|Drug Development Strategy, Regulatory Affairs|

FDA Approves First-of-its-Kind Automated Insulin Delivery and Monitoring System for Use in Young Pediatric Patients

Today, the U.S. Food and Drug Administration approved the MiniMed 770G System, a hybrid closed loop diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the users or their caregivers for use by individuals aged 2 to 6 with type 1 [...]

2020-09-04T18:41:54+00:0004.09.2020|Drug Development Strategy, Regulatory Affairs|

FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccines

The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological Products Advisory Committee will be held on Oct. 22, 2020, to discuss the general matter of the development, authorization, and/or licensure of vaccines indicated to prevent COVID-19. “The FDA has scheduled a meeting of its Vaccines and Related Biological Products [...]

2020-09-02T21:23:34+00:0002.09.2020|Drug Development Strategy, Regulatory Affairs|

FDA Broadens Emergency Use Authorization for Veklury (remdesivir) to Include All Hospitalized Patients for Treatment of COVID-19

Today, as part of its ongoing efforts to fight COVID-19, the U.S. Food and Drug Administration broadened the scope of the existing emergency use authorization (EUA) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease. In May 2020, the FDA issued [...]

2020-09-02T21:15:44+00:0002.09.2020|Drug Development Strategy, Regulatory Affairs|

FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly From Testing Card

Today, the U.S. Food and Drug Administration issued an emergency use authorization for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer. “This new [...]

2020-08-31T22:19:47+00:0031.08.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: España se suma a la compra centralizada de la CE de la vacuna 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. Esta vacuna es una de las alternativas más avanzadas y está ya llevando a cabo ensayos clínicos para garantizar su seguridad [...]

2020-08-27T20:20:22+00:0027.08.2020|Drug Development Strategy|

(Cas) La AEMPS moviliza del stock sobrante de ensayos clínicos de remdesivir para cubrir las necesidades actuales de pacientes

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. El stock de remdesivir es limitado y, debido al incremento dela demanda en las últimas semanas, se agotará temporalmente en las [...]

2020-08-27T20:03:12+00:0027.08.2020|Drug Development Strategy, Regulatory Affairs|

FDA Approves Treatment for Rare Disease Affecting Optic Nerves, Spinal Cord

The U.S. Food and Drug Administration has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a particular antibody – patients who are anti-aquaporin-4 or AQP4 antibody-positive. NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng is [...]

2020-08-24T19:07:40+00:0024.08.2020|Drug Development Strategy, Regulatory Affairs|

FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation

Today, the U.S. Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This is the second FDA-approved targeted treatment for patients with this type of mutation. Approximately [...]

2020-08-19T21:39:23+00:0019.08.2020|Drug Development Strategy, Regulatory Affairs|