article
The future of label management is with intelligent automation
Kiran Chinnalla and Julian Backhouse explain why automation for labelling in pharma can help the industry to remain compliant in the face of regulatory changes.
List view / Grid view
Legal
news
Certificates of Compliance or Attestation of Conformity have no legal standing under UK Medical Device Regulations 2002
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
article
Trademarks in the medical sphere: practice, examination and obstacles for registration in Russia, Ukraine and the CIS
Dr Tatiana Lipovaya and Alyona Chernoknyzhnaya discuss some of the main considerations when applying for trademarks in the pharmaceutical industry in Russia, Ukraine and the CIS.
news
Kymab wins UK court case against Regeneron’s patent claims
The UK Supreme Court has ruled that Regeneron's patent claim regarding genetically modified mice against Kymab are invalid.
article
Patents and approvals – medicines, vaccines and diagnostics for COVID-19
As companies race to develop a COVID-19 vaccine, various discussions about patents and ownerships of the vaccine have occurred, especially in light of funding from various governments. This article explores the patent and regulation issues, with a focus on patent extensions and suspensions for global good.
news
Epidyolex (cannabidiol) reclassified as Schedule 5 in UK, relaxing control over drug
GW Pharmaceuticals's Epidyolex (cannabidiol) has been changed from a Schedule 2 drug to a Schedule 5 drug, making it exempt from virtually all controlled drug requirements.
news
UK CMA disqualifies pharma company director after breaking competition law
A pharmaceutical company director is now banned from holding a director role at any UK company for the next five years after making illegal arrangements.
news
FTC accepts proposal for AbbVie to acquire Allergan for $63 billion
AbbVie and Allergan have announced the Federal Trade Commission has accepted AbbVie's pending acquisition of Allergan for $63 billion.
news
EMA to fast-track development of COVID-19 vaccines and therapeutics
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
news
Gilead files lawsuit against US federal government over alleged contract breaches
Gilead's complaint alleges five contract breaches by the US Centers for Disease Control and Prevention (CDC) and seeks a declaration of contract breach and damages.
article
Four MHRA ‘inspections and good practice’ guidances for the COVID-19 outbreak
Md Saddam Nawaz discusses four guidances released by the MHRA to help firms navigate the regulatory waters during the COVID-19 pandemic.
news
FDA sends two warnings to companies selling unapproved CBD products
Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
article
Tax competition in Life Sciences – how does the UK shape up?
Last month, the UK’s Chancellor of the Exchequer announced that corporation tax would be frozen at 19 percent, reversing previous plans to cut it to 17 percent. In this article, Lawrence Wild and Richard Turner expand further on what was delivered in the 2020 Budget and explore the relative competitiveness…
article
Post-Brexit: impact in the Life Sciences sector (so far)
In a Q&A with European Pharmaceutical Review, Marie Manley, Partner at Sidley Austin and Will Holmes, Associate at Sidley Austin discuss the post-Brexit landscape for Life Sciences.
article
Stem cells in the clinic: how are they regulated?
Dr Roger Barker, University of Cambridge, UK and Eric Anthony, International Society for Stem Cell Research (ISSCR), describe how stem cells are regulated around the world and why this is important for patient safety.
