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Wednesday 12 December 2018
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Topic: Haematology

August 30, 2018
The European Commission has approved Vyxeos 44 mg/100mg powder for concentrate for solution for infusion for the treatment of adults with newly-diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes, manufacturer Jazz Pharmaceuticals has announced.

The European Commission has approved Vyxeos 44 mg/100mg powder for concentrate for solution for infusion for the treatment of adults with newly-diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes, manufacturer Jazz Pharmaceuticals has announced.
 
Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ration of daunorubicin and cytarabine, Jazz Pharmaceuticals said.
 
The EC approval extends to all European member states as well as Iceland, Norway sand Liechtenstein.

August 30, 2018
The European Commission has approved Vyxeos 44 mg/100mg powder for concentrate for solution for infusion for the treatment of adults with newly-diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes, manufacturer Jazz Pharmaceuticals has announced.

The European Commission has approved Vyxeos 44 mg/100mg powder for concentrate for solution for infusion for the treatment of adults with newly-diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes, manufacturer Jazz Pharmaceuticals has announced.
 
Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ration of daunorubicin and cytarabine, Jazz Pharmaceuticals said.
 
The EC approval extends to all European member states as well as Iceland, Norway sand Liechtenstein.

August 30, 2018
Novartis UK Oncology statement on Novartis receiving European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)

Novartis UK Oncology statement on Novartis receiving European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel)
 
"Today’s (27 August) approval by the European Commission of Kymriah® (tisagenlecleucel), the only CAR-T therapy licensed in two different types of blood cancers, moves us one step closer to providing this revolutionary therapy to appropriate patients in the UK. 
 
 
 

August 6, 2018
New patient groups with cancer-associated venous thromboembolism (VTE) could benefit from taking once-daily oral LIXIANA (edoxaban), a recent analysis has said.

New patient groups with cancer-associated venous thromboembolism (VTE) could benefit from taking once-daily oral LIXIANA (edoxaban), a recent analysis has said.
 
Manufacturer Daiichi Sankyo announced today (6 July) it had published a new analysis on the clinical presentation, course and outcome of bleeding events in Thrombosis and Haemostasis, and the associated tumour types from the Hokusai-VTE cancer study.
 

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.

 

March 1, 2018
Hemlibra is a bispecific monoclonal antibody, which was developed using Chugai’s proprietary antibody engineering technologies

Chugai has announced that Roche has received regulatory approval from the European Commission for Hemlibra® (emicizumab) for routine prophylaxis of bleeding episodes in people with haemophilia A with factor VIII inhibitors.

 

February 28, 2018
Innovative Neulasta® Onpro® kit is designed to provide the right dose for patients at the right time

Amgen has announced that the CHMP has issued a positive opinion recommending a label variation for Neulasta® (pegfilgrastim) to include the Neulasta® Onpro® Kit.

 

February 26, 2018
CE-IVD labelled PAXgene® Blood ccfDNA tube will be available in Western Europe

BD has announced the commercial availability of the CE-IVD marked PAXgene® Blood ccfDNA tube within the European Economic Area and Switzerland (Western Europe).

 

February 8, 2018
The Republic of Ireland becomes the first country in Europe to switch an entire population undergoing treatment from conventional short-acting therapies to extended half-life therapies for haemophilia A and B

The Republic of Ireland has become the first country in Europe where every person with haemophilia will have access to the newest generation of haemophilia treatments, extended half-life therapies, under new supply contracts signed between the HSE (Health Services Executive) and Sobi™.
 

December 12, 2017
The analysis was presented in a poster session at the 59th Annual Meeting of the American Society of Hematology

Sobi and Bioverativ Inc have announced the results of a new, post-hoc, longitudinal analysis of the pivotal Phase III A-LONG study and ASPIRE long-term extension study, showing that weekly prophylactic dosing with its extended half-life therapy Elocta® (efmoroctocog alfa) has the potential to provide improved bleed protection over episodic treatment, resolve target joints and reduce the treatment burden associated with more frequent dosing intervals.

November 10, 2017
Positive opinion based on five studies demonstrating Nplate reduces rates of bleeding in children with rare blood disorder

Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for Nplate® (romiplostim) to include the treatment of chronic immune (idiopathic) thrombocytopenic purpura (ITP) for patients one year of age and older who are refractory to other treatments (for example,corticosteroids, immunoglobulins).

 

July 13, 2017
Emicizumab reduced treated bleed rate by 87% versus comparator in HAVEN 1 clinical study

Roche Products Ltd and Chugai Pharma UK Ltd have announced that data from HAVEN 1, a Phase III study of the investigational medicine emicizumab in people aged 12 or over with haemophilia A with inhibitors, were published online in The New England Journal of Medicine (NEJM).
 

May 5, 2017
Sandoz receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers

Sandoz has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both the biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
 

May 5, 2017
Sandoz receives positive CHMP opinions for biosimilars rituximab and etanercept to treat immunological diseases. Biosimilar rituximab also recommended to treat blood cancers

Sandoz has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions, separately recommending the approval of both the biosimilar rituximab and biosimilar etanercept in Europe, to treat the same indications as their respective reference medicines.
 

September 16, 2016
Idarucizumab (Praxbind®) accepted for use in NHS Scotland for patients taking dabigatran etexilate (Pradaxa®) who require urgent reversal of their anticoagulation

Boehringer Ingelheim is pleased to welcome the announcement by the Scottish Medicines Consortium (SMC)  that following a full review, it has accepted idarucizumab for use within NHS Scotland.1


Idarucizumab is a specific reversal agent for dabigatran etexilate and is indicated in adult patients when rapid reversal of the anticoagulant effect is required for emergency surgery or urgent procedures or in life threatening or uncontrolled bleeding.2

May 13, 2016
First Fc Fusion therapy approved for haemophilia B in the EU to provide extended protection against bleeds

Swedish Orphan Biovitrum AB (publ) (Sobi™) and Biogen announced that the European Commission (EC) has approved Alprolix® (rFIXFc), their extended half-life therapy, for the treatment of haemophilia B in all 28 European Union (EU) Member States and maintained its orphan designation. Alprolix is the only recombinant factor IX Fc Fusion protein therapy for haemophilia B to offer people in the EU prolonged protection against bleeding episodes with fewer prophylactic injections.

April 14, 2016
Swedish Orphan Biovitrum AB and collaboration partner Biogen have received a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency recommending the European Commission to maintain the orphan designation for Alprolix®, a recombinant factor IX Fc fusion protein therapy for the treatment of haemophilia B

March 31, 2016
First-ever treatment for rare bleeding disorder ‘hereditary factor X deficiency’ approved in Europe

Bio Products Laboratory, Limited (BPL) announced that the European Medicines Agency has granted marketing authorisation for Coagadex. Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. Coagadex is the first and only treatment licensed specifically for this rare bleeding disorder in Europe.1

March 21, 2016
BD Vacutainer® Barricor™ Tube designed to enhance sample quality, improve laboratory efficiency and speed laboratory turnaround time

BD (Becton, Dickinson and Company), a leading global medical technology company, has announced that it has obtained the CE mark in Europe for a next-generation blood separation technology that is designed to enhance sample quality, improve laboratory efficiency and reduce laboratory turnaround time.

 


BD Vacutainer® Barricor™ tube is a single-use, plastic evacuated tube used to collect, separate, transport and process venous blood specimens to obtain high-quality plasma for in vitro diagnostic use.

February 29, 2016
Sobi and Biogen received a positive opinion from CHMP of the European Medicines Agency recommending that marketing authorisation be granted for Alprolix®

January 11, 2016
Swedish Orphan Biovitrum AB announced the commercial launch of Elocta® in first countries in Europe

Swedish Orphan Biovitrum AB (publ) (Sobi(TM)) announced the commercial launch of Elocta® (efmoroctocog alfa) in first countries in Europe. Elocta is a recombinant human factor VIII Fc fusion protein with an extended half-life, and is the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days.

 

November 24, 2015
BLINCYTO first bispecific T cell engager (BiTE®) antibody construct approved in European Union

Amgen announced that the European Commission (EC) has granted conditional marketing authorisation for BLINCYTO® (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL).
 
Experience the interactive Multimedia News Release here: http://www.multivu.com/players/English/7414058-amgen-blincyto-europe-approval/.
 

September 9, 2015
Daratumumab is for European patients with heavily pre-treated multiple myeloma

Janssen-Cilag International NV announced it has submitted a new Marketing Authorisation Application to the European Medicines Agency (EMA) for daratumumab, an investigational, human anti-CD38 monoclonal antibody, for the treatment of patients with relapsed and refractory multiple myeloma.
 

August 18, 2015
Results from B-YOND study reinforce long-term clinical profile of Alprolix for the treatment of haemophilia B

Swedish Orphan Biovitrum AB (Sobi) and its partner Biogen released interim results from the B-YOND study presented at the 67th Annual Meeting for the National Hemophilia Foundation in Dallas, Texas. The results support the long-term safety and efficacy of Alprolix(R) (rFIXFc) in people with severe haemophilia B treated for up to two years. Participants in this Phase III, open-label long-term study maintained low bleeding rates with one to two week prophylaxis regimens. No inhibitors have been reported to-date.

 

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