In this week’s news, BIA stresses benefits of close EU ties, US FDA launches app for post-market studies, study looks at Humira delivery techs and more…
EU relations more important for UK pharma than post Brexit trade deals
A healthy relationship with the EU is more important to UK life sciences than trade deals struck after Brexit says the UK Bioindustry Association.
The industry group made its comments last week after a Department of International Trade request for input on planned trade negotiations with the US, New Zealand and Australia.
While the BIA did outline its priorities for post-Brexit deals, it used a later blog post to stress that UK pharma and biotech prosperity – and patient access to medicines – is more closely linked to interactions with the European Union.
“We’ve made it clear from the start that due to our sector’s integrated links with the EU, a close UK-EU relationship is more important than future trade deals.
The BIA added that, “The top priority continues to be the secure supply of medicines to UK patients as we leave the EU. For companies supplying medicines to the NHS, this is proving to be an enormous challenge.”
The organisation concluded that only after uncertainty surrounding post Brexit UK-EU relations is removed will it be appropriate to provide more detailed feedback on deals with countries outside the bloc.
US FDA launches real-world patient data collection app
The US FDA has released an app that can collect real-world drug performance data from patients.
The MyStudies app allows for the input of real world data directly by patients which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and registries.
The agency said, “It [the app] was developed by the FDA and private sector partners, but open source code and technical documentation are being released to the public, so the app and patient data storage system can be reconfigured by organizations conducting clinical research.”
According to BioCentury, the private sector partners included Harvard Pilgrim Health Care Institute, LabKey Corp. and Boston Technology Corp.
FDA Commissioner Scott Gottlieb said the app will “lead to more efficient product development and assist with safety monitoring.”
mHealthintelligence reported the app will be modified for both Apple’s ResearchKit and Google’s Android ResearchStack platforms.
Humira performance no impacted by choice of delivery tech says study
Humira is just as effective whether in a prefilled syringe or delivered with an autoinjector according to new study.
The research – published in Drug Design, Development and Therapy – looked at the impact the techs have on the pharmacodynamics, safety and tolerability of Imraldi, a Humira biosimilar made by Samsung Bioepis.
The authors wrote, “In healthy subjects receiving a single dose of SB5 [Imraldi] via AI or PFS, PK parameters and corresponding 90% CIs were within the predefined margins, showing bioequivalence between the two delivery methods.
They added that, “Safety and tolerability assessments were also similar between groups.”
Biosimilar competition has seen manufacturers shift from off-the-shelf systems to bespoke delivery techs to differentiate their products, as was pointed by Manufacturing Chemist earlier this year.
Third quarter boom for biotech IPOs says analyst
Biotechnology IPOs attracted $1.5bn in capital investment in the three months to the end of September according to CohnReznick.
The accounting firm shared details with Bioprocess-Insider last week, explaining that 20 biotechs went public in the period, which is roughly a third of all the flotations that took place.
The IPO surge – says Alex Castelli from CohnReznick – was driven by a number of factors, notably the FDA fast tracking approvals and “advances in science and technology that have improved the success of programs and improved manufacturing capabilities.”
Read the full story here.
Also in the news
Fiercepharma looked at alleged theft of trade secrets that prompted Roche’s Genentech unit to seek an injunction and damages.
According to the report, the case involves various “analytical methods, formulation know-how, quality acceptance criteria, and manufacturing protocols” employed by Genentech.
The London School of Hygiene and tropical medicine says visa restrictions imposed are hurting UK life sciences research.
The institution detailed its concerns in a letter to the Home Secretary, arguing that denying visas to experts from Africa, Asia and elsewhere impedes efforts to establish the UK as a research hub.
STAT writer Emily Mullin looked at manufacturing capacity in the cell and gene therapy manufacturing space.