Pfizer Takes Aim At Moderna's Leftover MRNA Protections
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Practice notes
The experimental use and Bolar-type exemptions to patent infringementPatent systems are intended to foster innovation, not to impede it. For this...
2nd Jun
In-house
News
The PMCPA has recently launched a consultation to update:•the 2021 ABPI Code of Practice•the Constitution and Procedure which sets out how the PMCPA...
3rd Jun
Precedents
Clinical Research Organisation (CRO) master services agreementDATA PROTECTION NOTICE: Please note that the drafting of clause 7 (Data Protection), in...
30th May
Practice notes
The EU Clinical Trials RegulationThis Practice Note looks at Regulation (EU) 536/2014, the EU Clinical Trials Regulation (CTR), which governs clinical...
Produced in partnership with Eveline Van Keymeulen of Latham & Watkins and Jeanne Fabre of Latham & Watkins
30th May
Precedents
Medical devices due diligence questionnaireIntroductionThis medical devices regulatory due diligence questionnaire relates to the proposed purchase by...
30th May
Flowcharts
Lifecycle of a medical device—flowchartThis Flowchart illustrates the typical lifecycle of a medical device. The lifecycle identifies eight key stages...
2nd Jun
Practice notes
Biotechnology patentsPatenting biotechnological inventionsBiotechnological inventions are, in principle, patentable. While there is no general...
30th May
Practice notes
Unlicensed medicinal products and off-label use of medicinal productsThis Practice Note explores unlicensed medicinal products and the various ways...
Produced in partnership with Dr Peter Feldschreiber of 4 New Square
30th May
News
The Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the implementation of changes to pharmacovigilance for...
3rd Jun
Practice notes
The regulation of medical devices in the UKThis Practice Note provides an overview of the UK regulatory regime for medical devices. It explains the...
30th May
News
The National Archives has published the judgment in British Standards Institution v RRR Manufacturing Pty Ltd, R (on the application of) [2024] EWCA...
3rd Jun
News
The Competition and Markets Authority (CMA) has announced a Phase 1 merger inquiry into Roche Diagnostics Ltd's acquisition of point-of-care testing...
3rd Jun
News
The Department for Science, Innovation and Technology (DSIT) has released the interim International Scientific Report on the Safety of Advanced...
3rd Jun
Practice notes
The regulation of advanced therapy medicinal productsThe development of medicine, biomicrobiology and biotechnology has led to the emergence of a...
Produced in partnership with Alexander Roussanov of Arnold & Porter and Heba Jalil of Arnold & Porter
30th May
Practice notes
Intellectual property protection for digital healthThis Practice Note discusses the various intellectual property (IP) rights that can be used to...
Produced in partnership with Dr. Fiona Kellas of Maucher Jenkins
2nd Jun
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