UK Life Sciences and Healthcare Newsletter - November 2021: Regulatory Updates

Dechert LLP

[co-author: Maddie Drabble]

Regulatory Updates:

  • Health and Care Bill: medicine information systems

    The Health and Care Bill was introduced to the House of Commons on 6 July 2021. Clause 85 of the Bill amends the Medicines and Medical Devices Act 2021 by inserting provisions relating to medicine information systems. Clause 85 confers powers to NHS Digital to collect information about the use of medicines and their effects in the UK and hold this data in one or more information systems. This information would be passed on to the MHRA for inclusion in medicines registries.
  • MHRA amends guidance on converting centrally authorised products into UK marketing authorisations

    The Medicines and Healthcare products Regulatory Agency has updated its guidance document on the conversion of Centrally Authorised Products into UK marketing authorisations. The update inserts a section on what marketing authorisation holders should submit to cancel a converted licence prior to 1 January 2022.
  • MHRA updates data integrity requirements for GLP Monitoring Programme members

    The Medicines and Healthcare products Regulatory Agency has updated its data integrity requirements for Good Laboratory Practice Monitoring Programme members following its adoption of the Organisation for Economic Cooperation and Development's (‘OECD') new Advisory Document on Data Integrity. The key differences in the OECD's new advisory document are specific guidance on GLP, the addition and alteration of definitions and new content on issues such as data recording and handling.

Market News:

Recent notable industry transactions:

  • Sandoz, a Novartis division has acquired GSK's cephalosporin antibiotics business. Sandoz has acquired rights to three established brands (Zinnat, Zinacef and Fortum) in over 100 markets. The brands had combined sales of approximately $140 million in the relevant markets in 2020.
  • Baylis Medical Company is selling its cardiology business to Boston Scientific Corporation for an upfront payment of $1.75 billion, subject to closing adjustments. The transaction is anticipated to close in the first quarter of 2022.
  • Merck has entered into a definitive agreement, through a subsidiary, to acquire Acceleron Pharma Inc., a publicly traded biopharmaceutical company, for an approximate total equity value of $11.5 billion. The transaction is expected to close in the fourth quarter of 2021.
  • AstraZeneca's Alexion is to acquire all remaining equity in Caelum Biosciences for CAEL-101, a potentially first-in-class fibril-reactive monoclonal antibody (mAb) for the treatment of light chain (AL) amyloidosis. Upon closing the acquisition, Alexion will pay Caelum the agreed option exercise price of approximately $150 million, with the potential for additional payments of up to $350 million upon achievement of regulatory and commercial milestones.
  • Novartis has acquired Arctos Medical, adding a pre-clinical optogenetics-based AAV gene therapy program and Arctos' proprietary technology to its ophthalmology portfolio. This underscores Novartis’ commitment to finding treatments and restoring vision for patients with severe vision loss.
  • AstraZeneca and VaxEquity have entered into a collaboration agreement to discover, develop and commercialise the proprietary self-amplifying RNA (saRNA) therapeutics platform developed at Imperial College London. The collaboration aims to optimise and validate VaxEquity's saRNA platform and apply it to advance novel therapeutic programmes.
  • Spark Therapeutics, a member of the Roche Group, and CombiGene AB have signed an exclusive collaboration and licencing agreement for an investigational gene therapy which aims to treat drug resistant focal epilepsy. The agreement provides Spark with the exclusive, worldwide licence to develop, manufacture and commercialise CombiGene's CG01 project.

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