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Friday 22 June 2018
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Topic: Latest News

June 20, 2018
Manufacturer Amgen has received approval from the European Commission (EC) to include overall survival (OS) data on the labels of the drug BLINCYTO (blinatumomab), it has announced.

Manufacturer Amgen has received approval from the European Commission (EC) to include overall survival (OS) data on the labels of the drug BLINCYTO (blinatumomab), it has announced.
 
The EC granted the company a full marketing authorisation for the drug based on the overall survival date from the Phase 3 TOWER study in adult patients with Philadelphia chromosome-negative (PH-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
 

June 20, 2018
Idorsia launches PRECISION – Phase 3 study with aprocitentan for resistant hypertension management in adults

Swiss biopharmaceuticals business Idorsia has announced that the first patient has been enrolled into PRECISION, a Phase 3 study to investigate the efficacy and safety of aprocitentan for managing resistant hypertension in adults [June 20 2018].
 

June 19, 2018
If passed, the legislation will provide hospital pharmacists with a legal defence for inadvertent dispensing errors

The UK’s Government is consulting on proposals to decriminalise dispensing errors for hospital pharmacists and technicians, it has announced.
 
The Department of Health and Social Care (DHSC) today (19 June) published a consultation on whether it should provide a legal defence for inadvertent dispensing errors for hospital pharmacists following the passing of a similar law protecting community pharmacists in April.
 

June 14, 2018
International team of researchers have developed new DNA test to identify men at greatest risk of prostate cancer

A saliva based DNA test to identify men who are at the highest risk of developing prostate cancer is to start early trials.
 
An international team of researchers led by scientists at The Institute of Cancer Research (ICR), London, have developed the new DNA test to unearth new genetic variants that were particularly hard to find.
 

June 14, 2018
Cancer fighting effects of aspirin revealed in bowel tumour study

Taking aspirin could help to prevent bowel cancer, researchers have suggested.
 
Regular use of aspirin is known to reduce the risk of developing colon cancer but the drug’s tumour fighting properties have not been well understood. Researchers at theUniversity of Edinburgh have found that the painkiller blocks a key process linked to tumour formation, shedding light on how taking aspirin can help to stave off bowel cancer.
 

June 12, 2018
A first of its kind treatment vaccine has moved into a phase I clinical trial for patients with non-small cell lung cancer (NSCLC), under a collaboration agreement between Cancer Research UK and Asterias Biotherapeutics Inc.

A first of its kind treatment vaccine has moved into a phase I clinical trial for patients with non-small cell lung cancer (NSCLC), under a collaboration agreement between Cancer Research UK and Asterias Biotherapeutics Inc.

 

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.
 

June 6, 2018
Evidence on whether cabozantinib increases the overall length of time people live is “less certain” says the National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence (NICE) has issued draft guidance rejecting first-line use of Ipsen/Exelixis’ Cabometyx in renal cancer on the NHS.

 

Cabometyx (cabozantinib) is a treatment for adult patients with advanced renal cell carcinoma (RCC) following prior vascular endothelial growth factor (VEGF)-targeted therapy.

 

June 4, 2018
An antifungal medication, commonly prescribed for toenail infections, could help eliminate dormant cells within bowel tumours

An antifungal medication, commonly prescribed for toenail infections, could help eliminate dormant cells within bowel tumours, according to new research funded by Cancer Research UK and published in the Journal of Experimental Medicine on Thursday.
 
 

June 4, 2018
Tegsedi has been approved by the EMA for treatment of stage 1 and 2 polyneuropathy in adults with hereditary transthyretin amyloidosis

Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of its orphan drug Tegsedi™ (inotersen), for the treatment of Stage 1 or Stage 2 polyneuropathy in adults with hereditary transthyretin amyloidosis (hATTR amyloidosis).1

 

 

June 4, 2018
Inclusion in the Cancer Drugs Fund will give more women in England and Wales with recurrent, platinum-sensitive ovarian cancer access to ZEJULA via a managed access arrangement

TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced the National Institute for Health and Care Excellence (NICE) will make ZEJULA®(niraparib), the first PARP inhibitor shown to be effective in patients with a BRCA mutation as well as those without a BRCA mutation, available to women in England and Wales with recurrent platinum-sensitive ovarian cancer via the Cancer Drugs Fund (CDF)[1]. 
 

June 1, 2018
Health and Social Care Committee identifies key areas associated with childhood obesity, which demand urgent attention from government

The Health and Social Care Committee has called on the UK government to make it clear that childhood obesity is “everyone’s business”.

 

June 1, 2018
Based on a recent planned review, the Data Monitoring Committee (DMC) recommends termination of Phase Ib/II study of daratumumab plus atezolizumab (anti PD-L1 antibody) in patients with previously treated non-small cell lung cancer

A mid-stage trial involving patients with pre-treated metastatic non-small cell lung cancer has been terminated after a combination of daratumumab (Janssen’s Darzalex) and atezolizumab (Roche’s Tecentriq) failed to show any benefit over the latter alone.
 
 

June 1, 2018
Nanoparticles carrying two drugs can cross the blood-brain barrier and shrink glioblastoma tumors

Researchers have devised a new drug delivering nanoparticle that could provide a better way to treat glioblastoma.

 

The particles, which carry two different drugs, are designed so that they can easily cross the blood-brain barrier and bind directly to tumour cells. One drug damages tumour cells’ DNA, while the other interferes with the systems cells normally use to repair such damage.

 

In a study of mice, the researchers showed that the particles could shrink tumours and prevent them from growing back.

 

May 24, 2018
European programme to help people access edaravone for ALS treatment established by pharmaceutical companies

Global pharmaceutical organisations have joined forces to improve access to a treatment for amyotrophic lateral sclerosis (ALS).

 

Clinigen Group plc has partnered with Mitsubishi Tanabe Pharma Corporation (MTPC) in Europe to initiate a ‘Managed Access Program’ for Edaravone, an intravenous treatment for ALS. The initiative is also known as ‘Early Access Program’.

 

Edaravone has been approved for use as a treatment for ALS in Japan, South Korea and the USA.

 

May 24, 2018
Children and adults treated with some oral antibiotics have a significantly higher risk of developing kidney stones, paediatric researchers have found

Children and adults treated with some oral antibiotics have a higher risk of developing kidney stones, paediatric researchers have suggested.

 

Researchers said this is the first time these medicines have been linked to this condition. The strongest risks appeared at younger ages, and also among patients most recently exposed to antibiotics.

 

May 24, 2018
Juluca (dolutegravir/rilpivirine), has been endorsed as the first 2-drug regimen, once-daily, single-pill for the treatment of HIV

The first two-drug regimen to treat some patients with HIV in Europe has been approved ViiV Healthcare and Janssen have announced.

 

Juluca consists of ViiV’s dolutegravir, which is an integrase strand transfer inhibitor, and Janssen’s rilpivirine 25mg, a non-nucleoside reverse transcriptase inhibitor.

 

May 22, 2018
The study analysed data from more than 421,000 people aged 60–69 in both GP medical records and in the UK Biobank research study. Participants were followed up over ten years.

New research has shown that older people with very low heart disease risks also have very little frailty, raising the possibility that frailty could be prevented.

 

The largest study of its kind, led by the University of Exeter, found that even small reductions in risk factors helped to reduce frailty, as well as dementia, chronic pain, and other disabling conditions of old age.

 

May 18, 2018
Green light for advanced bladder cancer patients whose disease has progressed following chemotherapy

Patients with advanced bladder cancer whose disease has progressed during or after treatment with platinum-containing chemotherapy, can now access the new immunotherapy Tecentriq (atezolizumab) via routine NHS funding in England and Wales.1

 

May 18, 2018
Nearly half of women with HIV lack help to manage menopause, a new study finds

Women with HIV are failing to get the support they need during menopause, according to a study led by University College London (UCL).

 

The PRIME (Positive Transitions through the Menopause) report  involved almost 900 women living with HIV aged 45-60 across England, who completed questionnaires and interviews between June 2015 and April 2018. Researchers found that 47% of women with HIV do not have the information they need to manage menopause.

 

May 17, 2018
Public health scheme aims to improve awareness of atopic dermatitis

A scheme to raise awareness about the emotional and physical impact of the most common type of eczema has been launched by a leading charity and a global biopharmaceutical company this month.

 

May 17, 2018
New indication supports Amgen’s commitment to reduce the risk of recurrent cardiovascular events faced by heart attack and stroke survivors

Amgen has announced announced that the European Commission (EC) has approved a new indication in the Repatha® (evolocumab) label for adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol (LDL-C) levels.

 

May 17, 2018
NICE U-turn recommends Biogen’s Avonex® (interferon beta-1a) for relapsing-remitting multiple sclerosis

The National Institute for Health and Care Excellence (NICE) has recommended global biotechnology  company Biogen’s Avonex® (interferon beta-1a) as an option for treating relapsing-remitting multiple sclerosis.

 

May 11, 2018
Neuromuscular blocking agents have a well-documented history of causing catastrophic injuries or death when inadvertently administered to adult and paediatric patients who were not receiving proper ventilatory assistance

Because neuromuscular blockers paralyse the muscles necessary for breathing, some patients have died or sustained serious, permanent injuries if the paralysis was not witnessed by a practitioner who could intervene.

 

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