Legal
The UK's medicines regulator has announced plans to deepen collaboration with the US FDA to accelerate innovation, strengthen patient safety and reduce barriers to market access. Speaking at the Advanced Medical Technology Association (AdvaMed) conference in San Diego, Medicines and Healthcare products Regulatory Agency (MHRA) chief executive Lawrence Tallon outlined plans to align medical technology [...]
By Reddie & Grose It is impossible to escape the headlines on GLP-1 agonists such as Ozempic and Wegovy. Therefore, it seems reasonable to assume that the innovator behind these blockbuster drugs has robust, fail-safe strategies to protect their intellectual property worldwide. However, inaction by Danish company Novo Nordisk, who manufactures Ozempic and Wegovy, has [...]
A US Centers for Disease Control vaccines advisory panel has voted to recommend separate vaccines for measles, mumps, rubella and chickenpox instead of a single combined jab. The advisory committee on immunisation practices (ACIP) shifted from recommending the combined MMRV vaccine to separate MMR and chickenpox doses. The move has raised concerns about compliance and [...]
International law firm McDermott Will & Schulte advised Sycamore Partners, a leading New York-based private equity firm, as UK healthcare regulatory counsel on its acquisition of Walgreens Boots Alliance, Inc. The total transaction is valued at up to $23.7 billion. Sycamore Partners specialises in consumer, distribution and retail-related investments and partners with management teams to [...]
International law firm McDermott Will & Schulte advised Five Arrows Manager SAS (as sponsor) and Axis Arbor (as debt advisor) in connection with a financing made available by Morgan Stanley and McQuarie Group for the Sponsor's acquisition of Hublo. Hublo is a company focused on transforming healthcare by improving how human resources are managed within [...]
McDermott Will & Schulte advised funds managed by Oaktree Capital Management, L.P. (“Oaktree”) in connection with a new four-year term loan facility of up to $125 million provided to OXB (LSE: OXB), a leading cell and gene therapy contract development and manufacturing organization (CDMO). The facility includes $60 million in initial funding, the majority of [...]
US medical experts warn against using ChatGPT for health advice after a 60-year-old man developed bromism following the chatbot’s dietary guidance. The patient developed bromide toxicity after consulting the AI app about eliminating table salt from his diet and subsequently taking sodium bromide for three months. Bromism, a “well-recognised” syndrome in the early 20th century, [...]
Surgeons at Great Ormond Street Hospital had to use phone torches during a spinal operation after a power outage, as reported by The Independent. The NHS safety watchdog found the hospital is facing ongoing maintenance issues, including power failures and water leaks. The Care Quality Commission (CQC) warned of “recurrent” problems, including the outage during [...]
The US Department of Health and Human Services said it would terminate 22 contracts for mRNA vaccine projects, questioning the safety of the technology. The cancelled contracts, worth nearly US$500m, include one with Moderna for development of a bird flu vaccine and rejected proposals from Pfizer, Sanofi Pasteur, CSL Seqirus and Gritstone. The Biomedical Advanced [...]
By Melissa Hall, Legal Director in MFMac’s Healthcare & Life Sciences team With the healthcare industry relying heavily on data for medical research and surveillance studies, it is critically important that sponsors, study sites and CROs know when data falls within the remit of 'personal data', which brings with it additional compliance requirements. Earlier this [...]
