Drug Development Strategy

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FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma

The U.S. Food and Drug Administration is announcing Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two [...]

2019-09-19T20:04:29+00:0019.09.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first treatment for patients with rare type of lung disease

The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the first FDA-approved treatment for this rare lung condition. “Patients suffering from scleroderma need effective therapies, and the FDA [...]

2019-09-12T20:21:43+00:0012.09.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Surdosage et overdose d’opioïdes: point sur l’offre thérapeutique de la naloxone en France

A l’occasion de l’Overdose Awareness Day ce samedi 31 août, l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) réalise un point de situation sur l’offre thérapeutique des antidotes aux opioïdes en France. L’ANSM a octroyé deux autorisations de mise sur le marché (AMM) pour des kits de naloxone prête à l’emploi: [...]

2019-09-10T20:23:47+00:0010.09.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Global public meeting on draft ICH guideline on clinical trials

The global guidance for the conduct of clinical trials is currently undergoing a major revision. As part of the worldwide consultation process, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is organising a public meeting to review its draft E8 (R1) Guideline ‘General Considerations for Clinical Trials’. EMA is encouraging its stakeholders to register [...]

2019-09-04T18:07:29+00:0004.09.2019|Drug Development Strategy, Regulatory Affairs|

ANSM: Cancer du sein: L’ANSM met à disposition deux nouveaux traitements innovants

Pour permettre un accès rapide et anticipé aux traitements innovants, l’ANSM a octroyé deux autorisations temporaires d’utilisation (ATU ) de cohorte à deux médicaments : Atezolizumab dans le traitement du cancer du sein triple négatif et Trastuzumab emtansine dans le traitement adjuvant  du cancer du sein de type HER2 positif avec une maladie résiduelle invasive. L’ANSM permet [...]

2019-09-03T17:00:57+00:0003.09.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new add-on drug to treat off episodes in adults with Parkinson’s disease

The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing "off" episodes. An "off" episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremor and difficulty walking. "Parkinson’s disease is a [...]

2019-09-03T16:58:10+00:0003.09.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new antibiotic to treat community-acquired bacterial pneumonia

The U.S. Food and Drug Administration today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. “This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, M.D., M.P.H., director of FDA’s Office of Antimicrobial Products. “For managing this serious disease, it is important [...]

2019-09-02T21:20:49+00:0002.09.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín mensual de la AEMPS sobre medicamentos de uso humano del mes de junio 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 Statement on data accuracy issues with recently approved gene therapy

As a public health agency, we believe that it is critical to facilitate the development of innovative safe and effective medical products, like the cellular and gene therapy products that have shown enormous potential to treat previously untreatable diseases. As part of the approval process for biological products, the agency reviews extensive information submitted by [...]

2019-08-12T19:41:30+00:0012.08.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first therapy for rare joint tumor

Today, the U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. “TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement. [...]

2019-08-08T19:50:32+00:0009.08.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published

EMA and the US Food and Drug Administration (FDA) have published today a  report  on their joint workshop with stakeholdersheld on 26 November 2018. The aim of this workshop was to discuss scientific and regulatory approaches to address quality and manufacturing challenges encountered during the development of medicines under early access programmes, such as the PRIority MEdicines scheme (PRIME) in the European [...]

2019-08-05T19:32:39+00:0005.08.2019|Drug Development Strategy|

FDA clears new indications for existing Lyme disease tests that may help streamline diagnoses

Today, the U.S. Food and Drug Administration cleared for marketing four previously cleared tests with new indications to aid in the diagnosis of Lyme disease. The tests cleared today are the first time that a test has been indicated to follow a new testing paradigm in which two tests called enzyme immunoassays (EIA) are run [...]

2019-08-05T19:18:32+00:0005.08.2019|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019

Five new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended five medicines for approval at its July 2019 meeting. The Committee recommended granting a conditional marketing authorisation for Vitrakvi* (larotrectinib), the first ‘histology-independent’ treatment in the European Union for solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. NTRK gene fusions occur very frequently in [...]

EMA: First ‘histology-independent’ treatment for solid tumours with a specific gene mutation

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Vitrakvi (larotrectinib) for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion. Treatment with Vitrakvi is recommended for patients whose disease has spread or cannot be surgically removed, and who [...]

2019-07-31T21:50:48+00:0031.07.2019|Drug Development Strategy, Regulatory Affairs|

(Cas) AEMPS: Boletín trimestral de la AEMPS sobre productos sanitarios y cosméticos Abril – Junio 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 severe hypoglycemia that can be administered without an injection

The U.S. Food and Drug Administration today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment of severe hypoglycemia that can be administered without an injection. Severe hypoglycemia occurs when a patient’s blood sugar levels fall to a level where he or she becomes confused or unconscious or suffers from other [...]

2019-07-31T20:01:09+00:0031.07.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves first generics of Lyrica

On July 19, the U.S. Food and Drug Administration approved multiple applications for first generics of Lyrica (pregabalin) for the management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, as an adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, for [...]

2019-07-24T22:04:43+00:0025.07.2019|Drug Development Strategy, Regulatory Affairs|

EMA takes note of the European Ombudsman’s decision on pre-submission activities

EMA welcomes the European Ombudsman’s recognition of the value and need for scientific advice and her recommendations are in line with EMA’s ongoing initiatives to further increase transparency. Early interactions with medicine developers and provision of scientific advice are well-established processes with demonstrated added value in medicines regulation, and contribute positively to public health by helping to bring new, [...]

2019-07-24T21:59:02+00:0024.07.2019|Drug Development Strategy, Regulatory Affairs|

FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections

The U.S. Food and Drug Administration has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). “The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” [...]

2019-07-22T20:04:13+00:0022.07.2019|Drug Development Strategy, Regulatory Affairs|