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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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.
A study evaluating the efficacy and safety of vericiguat, a treatment for patients with worsening chronic heart failure, has met the primary efficacy endpoint.
Adakveo has been approved by the FDA to reduce the frequency of vaso-occlusive crisis, a painful complication of sickle cell disease.
The EMA CHMP has revealed its suggestion to grant marketing authorisation to seven medicines after its most recent meeting.
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.
A new report has said the majority of the active ingredients used in pharmaceuticals have never been evaluated for environmental risks.
Aurobindo has recalled prescription and over-the-counter ranitidine due to the medications containing unacceptable levels of NDMA.
Specific batches of paracetamol tablets are being recalled as some pots have been found to contain discoloured tablets due to fungal contamination.
Janssen has submitted two Marketing Authorisation Applications to the EMA for an investigational Ebola vaccine regimen.
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.
Following guidance from the drugs advisory body NICE, two cannabis-based medications have been approved for treatment by the NHS in England.
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.