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Wednesday 21 November 2018
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Topic: EMA

June 6, 2018
First monoclonal antibody therapy for prevention of migraine

The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Aimovig (erenumab).
 
The EMA’s Committee for Medicinal Products for Human Use (CHMP) said the drug was the first human monoclonal antibody therapy for preventing migraine.
 
Aimovig, produced by Novartis Europharm, belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP) – a molecule that is involved in migraine attacks.
 

March 13, 2018
Patients with sickle cell disease suffer from debilitating episodes of sickle cell crises, which occur when the rigid, adhesive and inflexible red blood cells occlude blood vessels

Emmaus has announced that the company’s Marketing Authorisation Application (MAA) for Xyndari has been fully validated and is now under assessment by the European Medicines Agency (EMA) for the treatment of sickle cell disease.

 

May 31, 2017
Sandoz is seeking approval for their proposed biosimilars adalimumab and infliximab for use in all indications of their respective reference medicines, Humira and Remicade

Sandoz has announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications for biosimilars to AbbVie’s Humira® (adalimumab) and Janssen’s Remicade® (infliximab) both of which are used to treat immunological diseases.

 

Sandoz is seeking approval for biosimilar adalimumab and infliximab for use in all indications of their respective reference medicines.

 

January 18, 2017
Boehringer Ingelheim's adalimumab biosimilar candidate to Humira® has been accepted for regulatory review by the EMA and FDA
November 28, 2016
GSK announces regulatory submission of a Marketing Authorisation Application to the EMA for Shingtrix based on phase III clinical trial programme data for the prevention of shingles.

GlaxoSmithKline plc announced the regulatory submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for its candidate shingles vaccine, ShingrixTM, for the prevention of herpes zoster (shingles) in people aged 50 years or over.

 

August 26, 2016
Phase III data supporting submission suggests potential clinical benefit of daratumumab as a backbone therapy in combination with either a proteasome inhibitor or an immunomodulatory agent for relapsed multiple myeloma patients

Janssen-Cilag International NV has announced the submission of a Type II variation application to the European Medicines Agency (EMA), seeking to broaden the existing marketing authorisation for the immunotherapy Darzalex® (daratumumab) to include treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. The expanded indication is based on daratumumab in combination with lenalidomide (an immmunomodulatory agent) and dexamethasone, or bortezomib (a PI) and dexamethasone.

 

November 13, 2015
Drug database AdisInsight provides reliable data for researchers, strategists, regulators and healthcare providers

The European Medicines Agency (EMA) has signed a four-year agreement with Adis, a leading global provider of drug information, for AdisInsight, a database for drug research and development, disease treatment and decision-making. Adis is part of the leading global scientific, technical and medical publisher Springer.

 

May 6, 2015
Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the oral suspension formulation and the 20mg capsule of Orfadin (nitisinone) for the treatment of hereditary tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children; it is progressive in nature, may result in liver and kidney failure and can be fatal if untreated.

Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the oral suspension formulation and the 20mg capsule of Orfadin (nitisinone) for the treatment of hereditary tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children; it is progressive in nature, may result in liver and kidney failure and can be fatal if untreated.  

March 10, 2015
Amgen and its subsidiary Onyx Pharmaceuticals, Inc., announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) of Kyprolis® (carfilzomib) for injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA.

Amgen and its subsidiary Onyx Pharmaceuticals, Inc., announced that the European Medicines Agency (EMA) has accepted the Marketing Authorisation Application (MAA) of Kyprolis® (carfilzomib) for injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The MAA has been granted accelerated assessment by the EMA.
 

January 7, 2015
Shield Therapeutics (Shield), an independent pharmaceutical company focused on the development of specialist hospital pharmaceuticals, announced the recent acceptance for review by the European Medicines Agency (EMA) of the marketing authorisation application (MAA) for Feraccru (ST10, ferric maltol).

Shield Therapeutics (Shield), an independent pharmaceutical company focused on the development of specialist hospital pharmaceuticals, announced the recent acceptance for review by the European Medicines Agency (EMA) of the marketing authorisation application (MAA) for Feraccru (ST10, ferric maltol).  

August 27, 2014
Cubist Pharmaceuticals, Inc. has announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application for its investigational antibiotic ceftolozane/tazobactam.

Cubist Pharmaceuticals, Inc. has announced that the European Medicines Agency (EMA) has accepted for review the Company’s Marketing Authorization Application (MAA) for its investigational antibiotic ceftolozane/tazobactam.

Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract infections and complicated intra-abdominal infections, with a decision from the European Commission (EC) expected during the second half of 2015.
 

June 12, 2014
The European Association of Hospital Pharmacists has written to the Board of the European Medicines Agency expressing concern about proposals to restrict the viewing of clinical trial results to an ‘on-screen only’ version.

The European Association of Hospital Pharmacists (EAHP) has written to the Board of the European Medicines Agency (EMA) expressing concern about proposals to restrict the viewing of clinical trial results to an ‘on-screen only’ version.

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