The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
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Pfizer and BioNTech told that documents relating to their COVID-19 vaccine approval were accessed during a cyber-attack on the European Medicines Agency (EMA).
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.
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.
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.
The UK Supreme Court has ruled that Regeneron's patent claim regarding genetically modified mice against Kymab are invalid.
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.
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.
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.
AbbVie and Allergan have announced the Federal Trade Commission has accepted AbbVie's pending acquisition of Allergan for $63 billion.
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
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.
Md Saddam Nawaz discusses four guidances released by the MHRA to help firms navigate the regulatory waters during the COVID-19 pandemic.
Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
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…