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ANSM: Cannabis à visée thérapeutique en France: l’ANSM souscrit au cadre de la phase expérimentale de mise à disposition proposé par le Comité d’experts

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM) souscrit aux propositions du groupe d’experts (CSST) publiées le 28 juin sur le cadre pratique de l’accès au cannabis à visée thérapeutique en vue d’une expérimentation en France. L’agence et le ministère des solidarités et de la santé engagent dès à présent les [...]

2019-07-17T20:35:26+00:0017.07.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Llamada a los promotores para que publiquen los resultados de sus ensayos clínicos

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 Unión Europea recuerda a los promotores de ensayos clínicos la obligación de publicar toda la información sobre el protocolo y [...]

2019-07-10T20:56:53+00:0010.07.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for refractory multiple myeloma

Today, the U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two [...]

2019-07-10T20:50:32+00:0010.07.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Call for all sponsors to publish clinical trial results in EU database

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT). Transparency and public access to clinical trial results, whether positive or negative, are [...]

2019-07-10T20:45:44+00:0010.07.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare autoimmune disease of the central nervous system

The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. “Soliris provides the first [...]

2019-07-08T20:25:11+00:0008.07.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019

Three new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended three medicines for approval at its June 2019 meeting. The Committee recommended granting a marketing authorisation for Giapreza (angiotensin II), for the treatment of refractory hypotension in adults with septic or other distributive shock. Two informed consent applications received a positive opinion from the CHMP: Azacitidine Celgene (azacitidine), for the treatment [...]

EMA: New treatment for children with type 2 diabetes

EMA’s human medicines committee (CHMP) has recommended granting an extension of indication to Victoza (liraglutide) to include the treatment of children and adolescents aged 10 years or older with type 2 diabetes. This medicine is already approved for use together with diet and exercise in adults with type 2 diabetes, on its own or as an add-on [...]

2019-07-08T20:02:56+00:0008.07.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de mayo 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 treatment for chronic rhinosinusitis with nasal polyps

The U.S. Food and Drug Administration today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner lining of the sinuses) accompanied by chronic rhinosinusitis (prolonged inflammation of the sinuses and nasal cavity). This is the first treatment approved for inadequately controlled chronic rhinosinusis with nasal polyps. “Nasal polyps can lead to [...]

2019-07-02T20:33:39+00:0002.07.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

The U.S. Food and Drug Administration today approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. “There are women who, for no known reason, have reduced sexual desire that causes marked distress, and who can benefit from safe and effective pharmacologic treatment. Today’s approval provides women with another treatment [...]

2019-06-27T19:06:11+00:0027.06.2019|Drug Development Strategy, Regulatory Affairs|

FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older

The U.S. Food and Drug Administration today expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations. Last year, the FDA approved Symdeko to treat patients ages 12 and older who had the same specific genetic mutations. [...]

2019-06-27T19:01:19+00:0027.06.2019|Drug Development Strategy, Regulatory Affairs|

FDA Statement on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs

The U.S. Food and Drug Administration is committed to helping facilitate American patients’ access to lower-cost generic medicines by taking steps to enhance and streamline the development and approval process of high-quality generic drugs. The U.S. already has one of the most effective and efficient generic markets in the world. Generic drugs represented 90% of [...]

2019-06-22T10:40:25+00:0022.06.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for pediatric patients with type 2 diabetes

The U.S. Food and Drug Administration today approved Victoza (liraglutide) injection for treatment of pediatric patients 10 years or older with type 2 diabetes. Victoza is the first non-insulin drug approved to treat type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza has been approved to treat adult [...]

2019-06-19T21:07:27+00:0019.06.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de abril 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 chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma

Today, the U.S. Food and Drug Administration granted accelerated approval to Polivy (polatuzumab vedotin-piiq), in combination with the chemotherapy bendamustine and a rituximab product (a combination known as “BR”), to treat adult patients with diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least two prior therapies. Polivy is a novel antibody-drug [...]

2019-06-13T22:53:31+00:0013.06.2019|Drug Development Strategy, Regulatory Affairs|

FDA permits marketing of first medical device for relief of pain associated with irritable bowel syndrome in patients 11-18 years of age

The U.S. Food and Drug Administration today permitted marketing of the first medical device to aid in the reduction of functional abdominal pain in patients 11-18 years of age with irritable bowel syndrome (IBS) when combined with other therapies for IBS. IBS is a condition affecting the large intestines that can cause abdominal pain and [...]

2019-06-12T22:31:58+00:0012.06.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Phagothérapie: Publication du compte-rendu du CSST “Phagothérapie – retour d’expérience et perspectives”

L’Agence nationale de sécurité des médicaments et des produits de santé (ANSM) publie le compte-rendu du Comité Scientifique Spécialisé Temporaire (CSST) « Phagothérapie – Retour d’expérience et perspectives » qui s’est réuni le 21 mars 2019. L’ANSM a réuni le 21 mars 2019 un Comité Scientifique Spécialisé Temporaire (CSST) « Phagothérapie – Retour d’expérience et perspectives ». Ce  CSST [...]

FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

The U.S. Food and Drug Administration today approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections. “A [...]

2019-06-06T22:48:12+00:0006.06.2019|Drug Development Strategy, Regulatory Affairs|