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Executive Editor, Pharma Insights
UK
+35 year(s) experience
Pink Sheet
Participants in a recent webinar looked at how the coronavirus is changing the way we look at clinical trials and whether new EU COVID-19 guidance might hold lessons for future approaches to study design.
Topic Coronavirus
Medtech Insight
A global collaboration initiative launched by the World Health Organization is intended to foster the development of COVID-19 diagnostics, vaccines and medicines and to make sure they reach all those who need them.
Topic Coronavirus
Pink Sheet
Authorities Also Investing In Vaccines And Tests Amid concerns that the coronavirus outbreak could have an impact on the supply of APIs and other materials sourced from Chinese manufacturers, pharmaceutical companies are to assess their supply chain situation to help ensure patients do not experience medicine shortages.
Pink Sheet
Bluebird bio’s gene therapy Zynteglo, Akcea’s antisense drug Waylivra and BioMarin’s enzyme substitution therapy Palynziq were among the novel innovative medicines that were approved in Europe in 2019.
In Vivo
Three Brexit deadlines have come and gone, and the UK is still a member of the European Union. It will remain so until it agrees a withdrawal deal or leaves without one at the end of January 2020. Alternatively, it could secure yet another extension to the Article 50 period beyond January 31. Or it could decide not to leave at all.
Scrip
The pharmaceutical industry has come under attack by a UK parliament committee for failing to make medicinal cannabis products available for clinical trials, saying that a "robust research base" is needed on which to base future treatment decisions.
Topic Clinical trials Drug approval
Medtech Insight
Changes are being made to the UK’s Accelerated Access Collaborative to help streamline access to ground-breaking medicines and diagnostic tools in areas like dementia, diabetes and cancer.
Pink Sheet
Companies wanting to compete in the newly off-patent adalimumab market in England have until Oct. 22 to submit their bids. They will need to offer “competitive prices” if they are to secure the highest share of sales to the national health service. At the same time, NHS trusts and clinical commissioning groups have been warned not to accept discounted interim offers from suppliers keen to get a foot in the door.
Pink Sheet
New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.
Topic Drug approval Drug review
Pink Sheet
The BioIndustry Association wants the government to rule out a “no-deal” Brexit, saying it would be bad for patients and the life sciences sector.
Pink Sheet
Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.
Pink Sheet
A pilot project run by the European Pharmacopoeia is being expanded in an effort to produce general quality standards for monoclonal antibodies, following the adoption of a monograph for infliximab last November.
Scrip
Bristol-Myers Squibb has withdrawn its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC), following a similar move for liver cancer last year. But the mCRC withdrawal is likely to have limited commercial impact and the company is more interested in pursuing the product’s use in combination treatment for this indication.
Topic Cancer
Pink Sheet
A study to look at the factors that determine the uptake of biosimilars has been launched by the Finnish regulator.
Topic Biosimilars
Pink Sheet
The EMA has produced further guidance for pharmaceutical companies on the changes they will need to make as a result of Brexit
Topic Brexit
Pink Sheet
02 Jul 2020
Pink Sheet
02 Jul 2020
Generics Bulletin
30 Jun 2020
Pink Sheet
29 Jun 2020
Pink Sheet
26 Jun 2020
Pink Sheet
25 Jun 2020
Pink Sheet
24 Jun 2020
Pink Sheet
23 Jun 2020
In Vivo
23 Jun 2020
Pink Sheet
19 Jun 2020
Generics Bulletin
19 Jun 2020
Pink Sheet
18 Jun 2020
Pink Sheet
17 Jun 2020
Pink Sheet
16 Jun 2020
Pink Sheet
15 Jun 2020
