> Drug Development Strategy

(Cas) AEMPS: Aplicación para la notificación de investigaciones clínicas con productos sanitarios con marcado CE para indicaciones aprobadas con variación de la práctica clínica habitual (NEOPS)

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 AEMPS informa de la puesta en funcionamiento de una aplicación para la notificación electrónica de las investigaciones clínicas con productos [...]

2019-01-17T19:30:35+00:0017.01.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy

The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in patients 10 years and older who have responded inadequately to several alternative (refractory) treatments. "Prioritizing the approval of generic [...]

2019-01-17T19:22:22+00:0017.01.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Revised guideline aims to strengthen global approach to development of new antibacterial medicines

EMA has published a revision of its guideline on the evaluation of human medicines indicated for the treatment of bacterial infections for a six-month public consultation. Stakeholders can send their comments by 31 July 2019 to idwpecretariat@ema.europa.eu using the template provided. EMA plays an important role in the fight against antimicrobial resistance by supporting the development of new medicines and treatment approaches, especially [...]

2019-01-15T21:00:59+00:0015.01.2019|Drug Development Strategy, Regulatory Affairs|

L’ANSM souscrit aux premières conclusions du CSST sur la pertinence de l’usage du cannabis à visée thérapeutique

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) souscrit aux premières conclusions du groupe d’experts indépendants (CSST) publiées le 13 décembre sur la pertinence de l’usage du cannabis à visée thérapeutique. L’ANSM réunira à nouveau ce groupe d’experts de janvier à juin 2019 afin de disposer d’un avis avant l’été permettant, [...]

2019-01-03T20:34:19+00:0003.01.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for adult patients with rare, life-threatening blood disease

The U.S. Food and Drug Administration today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disease. “The approval of Ultomiris will change the way that patients with PNH are treated,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and [...]

2018-12-27T21:53:07+00:0028.12.2018|Drug Development Strategy, Regulatory Affairs|

FDA approves first treatment for rare blood disease

The U.S. Food and Drug Administration today approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients, two years of age and older. “Prior to today’s approval, there had been no FDA approved therapies for BPDCN. The standard of care has been intensive chemotherapy followed [...]

2018-12-28T12:18:45+00:0028.12.2018|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de noviembre de 2018

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: Responding to emerging health threats in the EU

EMA has published a plan outlining how it would respond to an emerging cross-border threat to health, such as an influenza pandemic. The health threats plan is based on the Agency’s pandemic influenza plan published in 2006 and reflects experience gained during the 2009 (H1N1) influenza pandemic  as well as the Ebola outbreak in Western Africa in 2014-2016. The plan [...]

2018-12-18T20:28:38+00:0019.12.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2018 meeting. Two orphan medicines received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly, and Trecondi (treosulfan), for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation. The CHMP recommended granting a marketing authorisation for Lusutrombopag Shionogi (lusutrombopag), for the treatment of severe [...]

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de octubre de 2018

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 [...]

L’ANSM s’engage dans l’accès plus rapide et plus sûr aux médicaments innovants pour les patients

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), garante de la sécurité et de la qualité des médicaments et produits de santé, a mis comme priorité en 2017 et 2018 le renforcement de son expertise dédiée aux essais précoces et la réduction de ses délais d’autorisation afin de donner un accès [...]

2018-12-11T21:25:11+00:0011.12.2018|Drug Development Strategy|

FDA takes new action to advance the development of reliable and beneficial genetic tests that can improve patient care

The U.S. Food and Drug Administration today took a significant step forward in driving the efficient development of novel diagnostic technologies that scan a person’s DNA to diagnose genetic diseases and guide medical treatments. For the first time, the agency has formally recognized a public database that contains information about genes, genetic variants and their [...]

2018-12-09T13:30:46+00:0010.12.2018|Drug Development Strategy, Regulatory Affairs|

ANSM: Plus de 10 000 personnes ont initié une prophylaxie pré-exposition (PrEP) au VIH par Truvada ou génériques

A l’occasion de la Journée mondiale de lutte contre le sida, l’Agence nationale de sécurité du médicament et des produits de santé (ANSM) actualise les données sur l’utilisation de la prophylaxie préexposition (PrEP) au VIH par Truvada ou génériques en France pour la période de janvier 2016 à juin 2018. Pour la première fois en [...]

2018-12-07T10:52:38+00:0007.12.2018|Drug Development Strategy|

EMA: Data from patient registries to replace clinical trials in previously untreated haemophilia patients

EMA has published revised guidelines on the tests and studies needed to support marketing authorisation applications for certain haemophilia medicines. The revision introduces an important change in relation to the investigation of recombinant and human plasma-derived factor VIII and factor IX haemophilia medicines in previously untreated patients: for this very small subset of haemophilia patients data should be collected [...]

2018-12-04T22:03:31+00:0005.12.2018|Drug Development Strategy, Regulatory Affairs|

FDA authorizes first test to aid in detecting a type of herpes virus in newborns called cytomegalovirus

Today the U.S. Food and Drug Administration permitted marketing of a new diagnostic test to aid in detecting a type of herpes virus called cytomegalovirus (CMV) in newborns less than 21 days of age. “Although most people who become infected with cytomegalovirus face little to no risk of serious illness, the virus has the potential [...]

2018-12-04T21:22:02+00:0004.12.2018|Drug Development Strategy, Regulatory Affairs|

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

The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS. [...]

2018-12-02T23:45:47+00:0003.12.2018|Drug Development Strategy, Regulatory Affairs|

FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma

The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment [...]

2018-12-02T23:39:49+00:0003.12.2018|Drug Development Strategy, Regulatory Affairs|

FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor

The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in [...]

2018-11-27T19:53:05+00:0027.11.2018|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de septiembre de 2018

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 [...]