Blog
RSS FeedPosted by Michael Wonder on 05 Apr 2023
MHRA grants ADvantage Therapeutics Innovative Licensing and Access Pathway designation for novel lead product AD04 for Phase 2b trial in Alzheimer’s sisease
5 April 2023 - ADvantage Therapeutics today announced that the MHRA has granted the Company’s lead compound AD04 an Innovation Passport ...
Posted by Michael Wonder on 05 Apr 2023
Ipsen reacts to NICE’s Cabometyx verdict
5 April 2023 - Company disappointed by institute’s failure to recommend thyroid cancer therapy for specific patient group ...
Posted by Michael Wonder on 05 Apr 2023
Faster UK drug approvals by relying on other countries
5 April 2023 - Safety and efficacy must be prioritised ahead of speed. ...
Posted by Michael Wonder on 04 Apr 2023
Daridorexant for the treatment of patients with insomnia disorder
3 April 2023 - The Department of Health and Social Care has asked the NICE to produce guidance on the ...
Posted by Michael Wonder on 29 Mar 2023
Hundreds of people are set to receive the first immunotherapy drug for advanced cervical cancer through the Cancer Drugs Fund
29 March 2023 - It is estimated that around 400 people with advanced cervical cancer will be eligible for pembrolizumab ...
Posted by Michael Wonder on 28 Mar 2023
From the European Medicines Agency to Project Orbis: new activities and challenges to facilitate UK oncology drug approval following Brexit
28 March 2023 - The departure of the UK from the European Union and affiliated European regulatory bodies, including the European ...
Posted by Michael Wonder on 28 Mar 2023
iOnctura awarded UK's MHRA Innovation Passport for entry into innovative licensing and access pathway
28 March 2023 - iOnctura today announces that the innovative medicine designation, the Innovation Passport, has been awarded for roginolisib, ...
Posted by Michael Wonder on 27 Mar 2023
Finerenone for the treatment of chronic kidney disease in patients with type 2 diabetes
23 March 2023 - NICE has issued evidence-based recommendations on the use of finerenone (Kerendia) for the treatment of adults ...
Posted by Michael Wonder on 25 Mar 2023
MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years
21 March 2023 - The legislative changes will help to make the UK one of the best countries in the world ...
Posted by Michael Wonder on 25 Mar 2023
NICE recommends life-changing gene therapy for children with ultra rare genetic disorder in final draft guidance
23 March 2023 - The first and currently only gene therapy for children with an ultra-rare genetic disorder has been recommended ...
Posted by Michael Wonder on 22 Mar 2023
Nivolumab in combination with chemotherapy for the neo-adjuvant treatment of patients with resectable non-small-cell lung cancer
22 March 2023 - NICE has published evidence based recommendations on the use of nivolumab (Opdivo) in combination with chemotherapy ...
Posted by Michael Wonder on 20 Mar 2023
UK to give “near automatic sign off” for treatments approved by “trusted” regulators
16 March 2023 - The UK Government has announced £10 million funding for the country’s medicines and devices regulator to ...
Posted by Michael Wonder on 15 Mar 2023
argenx announces UK MHRA approval of Vyvgart for the treatment of generalised myasthenia gravis
15 March 2023 - argenx is committed to collaborating with local authorities to facilitate broad and rapid access to Vyvgart for ...
Posted by Michael Wonder on 15 Mar 2023
MHRA to receive £10 million from HM Treasury to fast track patient access to cutting edge medical products
15 March 2023 - A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency to ...
Posted by Michael Wonder on 08 Mar 2023
NICE recommended weight loss drug to be made available in specialist NHS services
8 March 2023 - Thousands of people will soon be able to be prescribed a drug to help them lose weight ...