Gilteritinib not recommended by NICE for AML treatment
NICE has said it will not recommend gilteritinib for treatment of acute myeloid leukaemia (AML) due to uncertainty around long-term survival expectancy and its cost-effectiveness.
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EC approves Darzalex® in combination with VTd for multiple myeloma
The European Commission (EC) granted marketing authorisation for Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd) for multiple myeloma patients.
GSK halts Excedrin production due to manufacturing inconsistencies
GlaxoSmithKline has announced that it will not be manufacturing or distributing some of its Excedrin products after inconsistencies in ingredient transfer and weight.
Recommendations made by EMA to unlock big data potential
Ten priority actions have been recommended for the European medicines regulatory network to evolve its approach to data use.
FDA announces drug product recall due to lack of sterility assurance
FUSION IV Pharmaceuticals, Inc dba AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products to the user level as they do not adhere to federal guidelines.
‘Super-human’ red blood cells could revolutionise drug delivery
Modified ‘super-human’ red blood cells containing therapeutic compounds have been developed by researchers as a novel form of drug delivery.
First human clinical trial to study cannabinol initiated
The first company to study cannabinol as an active pharmaceutical ingredient has launched its Phase I clinical trial.
Immuno-oncology and personalised medicine to drive pharma in 2020
A survey of industry professionals states they expect immuno-oncology therapies and personalised medicines to continue to shape the pharmaceutical industry in the coming year.
PQE GROUP, the international quality solution provider, at Interphex to consolidate its presence in US
PQE Group, the consulting company in the pharmaceutical field, based in Italy, has chosen “Interphex” to strengthen its presence on the US market.
Less than half of US clinical trials comply with reporting regulations
Researchers have found that only 41 percent of trials reported their findings with a year after completion and suggest that over $4 billion in fines could have been collected in just 12 months.
Regulatory expansion submitted for SPRAVATO® (esketamine) nasal spray
Janssen have applied to the EMA to extend the use of esketamine to a short-term treatment for the rapid reduction of depressive symptoms in adults with MDD who are suicidal with the intent.
Lack of new antibiotics threatens battle against drug-resistant infections, WHO says
The World Health Organization (WHO) has released new reports which state that a lack of innovation in new antibiotic development is undermining efforts to combat drug-resistant infections.
UK records 178 medicine shortages in 2019, say reports
Research has found that last year, the UK government recorded 178 medicine shortages, an increase of 19 upon 2018.
Edible security tag for drugs developed to combat counterfeits
Researchers have created a unique edible film to be added onto the surface of drugs which can produce a security key, preventing counterfeits from reaching patients.
NICE recommends olaparib tablets for platinum-sensitive cancer patients
NICE has recommended olaparib tablets (Lynparza, AstraZeneca) for adults with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer with a BRCA1 or BRCA2 mutation.
