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Friday 13 July 2018
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Topic: *** Editor's Pick

July 11, 2018
The drug will be now available for dose optimisation in UC patients with a body weight of less than 80kg, who do not respond to induction therapy.

The European Commission (EC) has approved a label change for Simponi (golumumab) allowing early dose optimisation in patients with ulcerative colitis (UC).
 
The drug will be now available for dose optimisation in UC patients with a body weight of less than 80kg, who do not respond to induction therapy.
 

July 10, 2018
In draft guidance published on 9 July NICE recommended that healthcare professionals prescribe antibiotics to people with COPD only when suffering from severe acute exacerbations

Antibiotics should be restricted when used for chronic obstructive pulmonary disease (COPD), the National Institute for Health and Care and Excellence (NICE) has urged.
 

July 5, 2018
Cimzia can be used for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, following label extension by European Medicines Agency (EMA)

The European Medicines Agency (EMA) has approved a label extension for Cimzia (certolizumab pegol) therapy, Belgian biopharmaceutical company UCB has announced.
 
The extension allows Cimzia’s use for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
 

July 4, 2018
A clinical trial to treat female diffuse hair loss has been kick started by US regenerative medicine company Histogen.

A clinical trial to treat female diffuse hair loss has been kick started by US regenerative medicine company Histogen.
 
This month [June 2 2018], the organisation announced the launch of a Phase I Clinical Trial of its lead product, Hair Stimulating Complex, to treat the condition.
 

July 2, 2018
The CHMP has given a positive opinion recommending Novartis’s Kymriah (tisagenlecleucel) to treat two aggressive blood cancers.

The Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending Novartis’s Kymriah (tisagenlecleucel) to treat two aggressive blood cancers.
 
The CHMP, which is part of the European Medicines Agency (EMA), gave a positive opinion on using tisagenlecleucel to treat B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-stem cell transplant or in second or later relapse in patients up to 25 years of age.
 

June 28, 2018
First patient with metastatic breast cancer receives treatment to look at anti-tumour effect and tolerability using new drug response predictor

A drug trial on a patient with metastatic breast cancer selected by a new drug response predictor has been launched.
 

June 28, 2018
First cannabinoid prescription medicine to be approved in the US endorses Epidiolex to treat two rare forms of childhood-onset epilepsy

The first cannabinoid prescription in the US has been given the green light by the US Food and Drug Administration (FDA) [June 25 2018].
 
GW Pharmaceuticals’ Epidiolex has been approved to treat two rare forms of childhood onset epilepsy - Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome.
 

June 27, 2018
Oral Semaglutide demonstrates significant reduction in blood sugar versus placebo in trial

A once-daily tablet could reduce blood sugar in adults with type 2 diabetes, a study has shown.
 
Oral semaglutide, an investigational GLP-1 analogue from global healthcare company Novo Nordisk,achieved “significant reductions in blood sugar versus placebo in adults with type 2 diabetes”, according to the PIONEER 1 phase 3a trial.
 
The trial evaluated the efficacy and safety of 3, 7 and 14 mg oral semaglutide compared with placebo as monotherapy over 26 weeks in adults with type 2 diabetes. [1] 
 

June 22, 2018
A report from the charity Cancer Research UK has called on the health service to prepare for a large increase in the number of over 75s with cancer

The number of elderly people developing cancer in the UK is expected to nearly double, hitting almost a quarter of a million a year by 2035, new cancer research has predicted.
 
A report from the charity Cancer Research UK has called on the health service to prepare for a large increase in the number of over 75s with cancer. It stated an expected a rise from some 130,000 elderly cancer patients a year to 234,000, in less than 20 years.
 

June 21, 2018
Targeted therapy to block a protein that suppresses T cell activity could improve cancer treatment with immune checkpoint inhibitors

A targeted therapy to block a protein that suppresses T cell activity could improve cancer treatment with immune checkpoint inhibitors, researchers have found.
 
EZH2 is elevated in immune T cells in patients after treatment with ipilimumab, a team at the University of Texas MD Anderson Cancer Center showed. The drug unleashes an immune response by blocking the activity of CTLA-4 on T cells – white blood cells that serve as the ‘targeted warriors’ of the adaptive immune system.
 

June 21, 2018
Global pharmaceutical company to discontinue a late-stage trial assessing the efficacy of an experimental therapy in reducing chronic cluster headaches.

Global pharmaceutical company Teva is to end a late-stage trial of fremanezumab for chronic cluster headaches. Its ENFORCE Phase III clinical development programme includes a chronic cluster headache study, an episodic cluster headache study, and a long-term safety study.
 
A pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period was unlikely to be met, Teva said [June 15 2018].
 

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 14, 2018
Treatments such as stem cell therapy should be available on the NHS, according to respondents to a national survey

New and potentially life-saving medical treatments, such as proton beam therapy, bone marrow transplant and stem cell therapy should be made available from the National Health Service, according to a new UK-wide survey. It found that 90% of respondents believed such treatments, which currently can only be accessed privately in the UK or overseas, should be freely available.
 

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 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.
 
This month, [June] NICE said Cabozantinib was not recommended, within its marketing authorisation, for adults with untreated advanced renal cell carcinoma that is intermediate or poor risk.

June 4, 2018
Tsegdi 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, announced today 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, an oncology-focused biopharmaceutical company, has 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 29, 2018
This study investigated the reasons why just 21% of patients enrolled in the PARADIGM-HF trial were women

Clinical trial enrolment favours men, according to a study presented at Heart Failure 2018 and the World Congress on Acute Heart Failure, a European Society of Cardiology congress.