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FDA approves first treatment specifically for patients with rare and life-threatening type of immune disease

The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. This FDA approval is the first for a drug specifically for HLH. “Primary HLH is a [...]

2018-11-20T19:50:09+00:00 21.11.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Valsartan from Mylan laboratories in India can no longer be used in EU medicines due to NDEA impurity

Authorities in the EU are taking action after an impurity, N-nitrosodiethylamine (NDEA), was found in some batches of valsartan made by Mylan Laboratories Limited in Hyderabad, India. EDQM has now suspended the manufacturer’s CEP (a certificate of compliance with European standards for quality testing), effectively prohibiting the use of its valsartan in EU medicines. In addition, national [...]

Infarmed: Sistema de Preços de Referência – Aditamento (4.º trimestre de 2018)

No âmbito do Sistema de Preços de Referência, a lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 4.º trimestre de 2018 foi atualizada. Consulte a área Sistema de Preços de Referência, na página Comparticipação, nomeadamente a Circular Informativa N.º 159/CD/100.20.200, de 14/11/2018 e a Deliberação N.º 81/CD/2018. Posted on the Infarmed website on [...]

2018-11-18T12:15:59+00:00 19.11.2018|Regulatory Affairs|

FDA approves new drug to treat travelers’ diarrhea

The U.S. Food and Drug Administration today approved Aemcolo (rifamycin), an antibacterial drug indicated for the treatment of adult patients with travelers’ diarrhea caused by noninvasive strains of Escherichia coli (E. coli), not complicated by fever or blood in the stool. "Travelers' diarrhea affects millions of people each year and having treatment options for this condition can [...]

2018-11-18T12:10:11+00:00 19.11.2018|Drug Development Strategy, Regulatory Affairs|

FDA’s efforts to hold industry accountable for fulfilling critical post-marketing studies of the benefits, safety of new drugs

The FDA remains committed to ensuring that FDA-approved drugs are safe and effective for Americans. As part of this commitment, we require evidence from premarket clinical trials that the medicine will be both effective and safe for use when prescribed according to its labeling. However, it’s not unusual for the FDA to identify issues that [...]

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval [...]

2018-11-18T12:00:21+00:00 19.11.2018|Drug Development Strategy, Regulatory Affairs|

EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2018

EMA’s human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting. The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is [...]

EMA: CHMP recommends first oral-only treatment for sleeping sickness

EMA’s human medicines committee (CHMP) has adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis (HAT), commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on [...]

2018-11-18T11:42:25+00:00 18.11.2018|Drug Development Strategy, Regulatory Affairs|

UK MHRA: Drug Safety Update (November 2018)

Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use Advise patients taking hydrochlorothiazide-containing products of the cumulative, dose-dependent risk of non-melanoma skin cancer, particularly in long-term use, and the need to regularly check for (and report) any suspicious skin lesions or moles. Systemic and inhaled fluoroquinolones: small increased risk of aortic aneurysm and dissection; [...]

2018-11-15T19:20:15+00:00 16.11.2018|Pharmacovigilance|

EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision

A report on EMA’s 24 September 2018 meeting with industry stakeholders to discuss the UK’s withdrawal from the European Union and the impact on the operation of the centralised procedure for human and veterinary medicines, published today, outlines how the European medicines regulatory network is preparing for Brexit, including EMA’s relocation and business continuity planning. At the meeting, participants were updated on EMA’s Brexit preparedness [...]

2018-11-15T19:03:59+00:00 15.11.2018|Regulatory Affairs|

WHO Pharmaceuticals Newsletter (No.5, 2018)

The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities around the world. It also provides signals based on information derived from Individual Case Safety Reports (ICSRs) available in the WHO Global ICSR database, VigiBase®. This newsletter also includes a short report from [...]

2018-11-15T18:57:58+00:00 15.11.2018|Pharmacovigilance|

EMA gives guidance on safety monitoring of medicines used in children

EMA has published the new good pharmacovigilance practice (GVP) chapter IV on specific considerations for the paediatric population. It offers a holistic view of paediatric pharmacovigilance and provides guidance on how to make best use of existing tools and processes to address the specific needs and challenges of safety monitoring of medicines used in children. In addition it advises [...]

2018-11-13T22:24:21+00:00 14.11.2018|Pharmacovigilance, Regulatory Affairs|

Infarmed: Metamizol e risco de agranulocitose

Na sequência de diversas notícias relativas à utilização de medicamentos contendo metamizol, o Infarmed informa: O metamizol é um medicamento utilizado para o tratamento da dor e febre há cerca de 40 anos. Em Portugal, os medicamentos comercializados contendo metamizol são Nolotil, Dolocalma e Metamizol Cinfa. A utilização de medicamentos contendo esta substância pode causar [...]

2018-11-13T21:34:48+00:00 14.11.2018|Pharmacovigilance|

FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to [...]

ANSM: Risques liés à l’utilisation des préparations coliques

A la suite des résultats d’une enquête française de pharmacovigilance sur les préparations coliques, l’ANSM souhaite rappeler les risques liés à leur utilisation. Des troubles hydro-électrolytiques survenant parfois dans un contexte de mésusage peuvent être à l’origine de décompensation cardiaque, de troubles du rythme ou de troubles neurologiques. Des manifestations allergiques ont également été mises [...]

2018-11-12T22:49:20+00:00 13.11.2018|Pharmacovigilance|

FDA Guidance for Industry: Hypertension: Developing Fixed-Combination Drug Products for Treatment

The purpose of this guidance is to assist sponsors in the clinical development of fixed-combination drug products for the treatment of hypertension. This guidance focuses on development of two-drug combinations of previously approved drugs, although the general approach is readily applicable to three or more drugs in combination. This guidance does not address combinations that include unapproved drug products. [...]

2018-11-12T22:42:01+00:00 13.11.2018|Regulatory Affairs, Training|

EMA: Human medicines highlights – November 2018

This newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. Information is selected based on recommendations from consulted patients, consumers and healthcare professionals, and does not necessarily cover all [...]

FDA authorizes emergency use of first Ebola fingerstick test with portable reader

Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test available under EUA, but the first that uses a portable battery-operated reader, which can help provide clear diagnostic [...]

2018-11-11T13:02:36+00:00 12.11.2018|Drug Development Strategy, Regulatory Affairs|

ANSM: Kétamine: risque d’atteintes uro-néphrologiques, endocriniennes et hépatiques graves lors d’utilisations prolongées et/ou à doses élevées

Information destinée aux anesthésistes réanimateurs, aux centres de prise en charge de la douleur, aux centres de prise en charge de brûlés, aux néphrologues, aux centres de transplantation hépatique, aux HAD et aux pharmaciens hospitaliers.  Dans des contextes d’utilisation prolongée et/ou répétée de kétamine (dont utilisation dans des indications hors-AMM) et en cas d’abus ou [...]

2018-11-11T12:53:15+00:00 12.11.2018|Pharmacovigilance|