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Fast Track Designation received for Prader-Willi syndrome treatment
Levo Therapeutics has received Fast Track Designation from the FDA for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome.
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Medical cannabis: face-to-face with Dr Amir Englund
Dr Englund discusses his research into medical cannabis, highlighting a range of its potential uses. He also explores some of the challenges that can be faced in clinical trials when investigating cannabinoids.
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Primary endpoint met in drug study for worsening chronic heart failure
A study evaluating the efficacy and safety of vericiguat, a treatment for patients with worsening chronic heart failure, has met the primary efficacy endpoint.
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Therapy approved for patients with sickle cell disease complication
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
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EMA announces medicine approval recommendations from November meeting
The EMA CHMP has revealed its suggestion to grant marketing authorisation to seven medicines after its most recent meeting.
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ABPI release medicine manifesto for new UK government after election
The ABPI’s Manifesto for Medicine has been issued, calling upon the next government in the UK to work closely with the pharma industry to increase innovation and access to medicines.
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Pharmaceutical residues risks need to be evaluated, says report
A new report has said the majority of the active ingredients used in pharmaceuticals have never been evaluated for environmental risks.
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Aurobindo recalls prescription and over-the-counter ranitidine
Aurobindo has recalled prescription and over-the-counter ranitidine due to the medications containing unacceptable levels of NDMA.
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Paracetamol tablets recalled due to potential fungal contamination
Specific batches of paracetamol tablets are being recalled as some pots have been found to contain discoloured tablets due to fungal contamination.
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EU Marketing Authorisation submitted for Ebola vaccine regimen
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
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Reblozyl approved for beta thalassaemia treatment
The US Food and Drug Administration (FDA) has granted Orphan Drug designation to Reblozyl for the treatment of anaemia in adults with beta thalassaemia.
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ICH Q12: Technical and regulatory considerations for pharmaceutical product lifecycle management
The International Conference on Harmonisation (ICH) is drafting guidance for product lifecycle management (ICH Q12) – currently stage 2b, which requires application of the concepts of Quality by Design (QbD) to ongoing lifecycle management and change control. Dave Elder dissects the guidance and discusses considerations for industry professionals.
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NHS England approves the use of two cannabis-based drugs
Following guidance from the drugs advisory body NICE, two cannabis-based medications have been approved for treatment by the NHS in England.
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Ziextenzo™ biosimilar has received approval from the FDA
The FDA has approved Sandoz's biosimilar Ziextenzo and the company now intends to launch it in the US as soon as possible this year.
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Winners of the 2019 CPhI Pharma Awards announced
Thirteen winners have been announced for the 2019 CPhI Pharma Awards including Dr Ge Li for ‘CEO of the Year’ and a ‘Lifetime Achievement' award for John Chiminski.