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(Cas) AEMPS: Recomendaciones para desarrollar el potencial del big data para la salud pública en la UE

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 grupo de trabajo conjunto sobre big data formado por expertos de la Agencia Europea de Medicamentos (EMA) y Jefes de Agencias de [...]

2020-01-22T21:41:54+00:0022.01.2020|Drug Development Strategy, Regulatory Affairs|

EMA: Ten recommendations to unlock the potential of big data for public health in the EU

The joint Big Data Task Force of EMA and the Heads of Medicines Agencies (HMA) proposes ten priority actions for the European medicines regulatory network to evolve its approach to data use and evidence generation, in order to make best use of big data to support innovation and public health, in a report published today . Big data are extremely large, rapidly [...]

2020-01-22T20:40:25+00:0022.01.2020|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de noviembre 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 the first targeted therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach [...]

2020-01-12T12:31:30+00:0012.01.2020|Drug Development Strategy, Regulatory Affairs|

EMA Human medicines: highlights of 2019

EMA has published an overview of its key recommendations in 2019 on the authorisation and safety monitoring of medicines for human use. Innovative medicines are essential to advancing public health as they bring new opportunities to treat certain diseases. In 2019, EMA recommended 66 medicines for marketing authorisation. Of these, 30 had a new active substance which had never been authorised [...]

FDA approves first generics of Eliquis

The U.S. Food and Drug Administration has approved two applications for the first generics of Eliquis (apixaban) tablets to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. Apixaban is also indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who [...]

2020-01-07T20:57:25+00:0007.01.2020|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for adults with migraine

The U.S. Food and Drug Administration today approved Ubrelvy (ubrogepant) tablets for the acute (immediate) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Ubrelvy is not indicated for the preventive treatment of migraine. It is the first drug in the class of oral calcitonin gene-related peptide receptor antagonists [...]

2020-01-07T20:48:46+00:0007.01.2020|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies

Today, the U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. [...]

2019-12-30T14:27:43+00:0030.12.2019|Drug Development Strategy, Regulatory Affairs|

EMA Management Board: highlights of December 2019 meeting

The December meeting of EMA’s Management Board was hosted by the Dutch government as the Agency’s interim building is now closed to prepare for the move to the new EMA building in Amsterdam Zuidas in January 2020. The move to the final building opens a new chapter for EMA and will allow the Agency to fully refocus [...]

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

The U.S. Food and Drug Administration announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S., and those that have occurred have been the result of [...]

2019-12-28T12:12:35+00:0028.12.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new type of therapy to treat advanced urothelial cancer

Today, the U.S. Food and Drug Administration granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, meaning the drug specifically targets cancer cells – in this case, the cell adhesion molecule Nectin-4, which is highly expressed in urothelial cancers. Padcev is indicated for the treatment of adult patients with locally [...]

2019-12-27T14:51:02+00:0027.12.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves use of drug to reduce risk of cardiovascular events in certain adult patient groups

The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or [...]

2019-12-19T20:58:07+00:0019.12.2019|Drug Development Strategy, Regulatory Affairs|

FDA clears first fully disposable duodenoscope, eliminating the potential for infections caused by ineffective reprocessing

The U.S. Food and Drug Administration today cleared for marketing in the U.S. the first fully disposable duodenoscope. The EXALT Model D Single-Use Duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. “The availability of a fully disposable duodenoscope represents [...]

2019-12-18T20:20:03+00:0018.12.2019|Drug Development Strategy, Regulatory Affairs|

FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system

The U.S. Food and Drug Administration today authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). This is the first such controller that [...]

2019-12-18T20:17:21+00:0018.12.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 December 2019

Five new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended five medicines for approval at its December 2019 meeting. The Committee recommended granting a marketing authorisation for Beovu (brolucizumab) for the treatment of neovascular (‘wet’) age-related macular degeneration, a disease that affects the central part of the retina at the back of the eye and causes loss [...]

2019-12-18T20:03:36+00:0018.12.2019|Drug Development Strategy, Regulatory Affairs|

FDA grants accelerated approval to first targeted treatment for rare Duchenne muscular dystrophy mutation

The U.S. Food and Drug Administration today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. It is estimated that about 8 percent of patients with DMD have this mutation. “The FDA recognizes [...]

2019-12-17T21:37:48+00:0017.12.2019|Drug Development Strategy, Regulatory Affairs|

FDA authorizes first test to aid in newborn screening for Duchenne Muscular Dystrophy

Today, the U.S. Food and Drug Administration authorized marketing of the first test to aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. “Diagnostics that can safely and effectively screen newborns can help health care professionals identify and discuss potential treatment options with parents [...]

2019-12-17T21:33:51+00:0017.12.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de octubre 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 first generics of Gilenya

The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. “Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” said Janet Woodcock, M.D., director of [...]

2019-12-09T20:26:11+00:0009.12.2019|Drug Development Strategy, Regulatory Affairs|