In this week’s news, branded pharma accused of biosimilar misinformation campaigns, expert says more needed to encourage antibiotic development, US FDA wants cybersecurity for med devices and more…
Misinformation campaigns hurting biosimilars says generics group
Misinformation campaigns backed by branded drug manufacturers are holding back adopting of biosimilar medicines according to US generics industry advocacy group, the Biosimilars Council.
The organisation made the allegation last week, suggesting the campaigns are “often driven or silently funded by brand manufacturers” aiming to sow doubts about biosimilars among patients, prescribers and policy makers.
These doubts threaten the “health of the very patients who stand to benefit from greater access to these treatments.”
The group also pointed out that the US FDA only approves a biosimilar if it has no clinically meaningful differences from the reference product in terms of safety, purity and potency.
To date, nine biosimilars have been approved in the US compared with around 40 in the European Union.
Pharma needs more encouragement to develop new antibiotics
The drug industry needs to be encouraged to develop new antibiotics according to Peter Jackson from the UK based Antimicrobial Resistance Centre.
In an opinion piece this week, Jackson said efforts to make antibiotic development more attractive for drug companies have not gone far enough.
He said, “Funding initiatives such as CARB-X, ENABLE and GARD-P, have pledged around $600 million for pre-clinical to clinical translation of new treatments and diagnostics.
“This is a great start, but as highlighted in the recent expert report by DRIVE-AB, such PUSH funding needs to be increased significantly to provide a sustainable early-stage pipeline of new treatments effective against AMR.”
According to Jackson the number of antibiotic patent applications worldwide has dropped by over half in the past decade.
UK scientists can seek Horion2020 funding after Brexit says Gov
UK drug researchers will still be able to bid for funding under the EU’s Horizon 2020 research scheme after Brexit.
The UK Government clarified the position last week. It said, “The UK and the EU fully intend UK entities’ eligibility in Horizon 2020 to remain unchanged for the duration of the programme, as set out in the Joint Report.
“This includes eligibility to participate in all Horizon 2020 projects and to receive Horizon 2020 funding for the lifetime of projects.”
UK researchers and innovators have been awarded 15% of all funds issued by Horizon 2020 to date, totalling around €4 billion. In addition, there have been 38,000 collaborative links made between UK researchers and colleagues in EU member states.
UF FDA to encourage device makers to use cybersecurity tech
The US FDA has outlined plans to change how it will regulate medical devices to take into account advances in materials, digital tech and manufacturing.
FDA Commissioner Scott Gottlieb wrote about the changes last week, explaining, “Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs.”
The plan will include setting up a robust medical device patient safety network, look at how to streamline post approval requirements and initiatives to advance industry use of cybersecurity technologies.
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The US FDA has revised its draft guidance on the production of inhalers.