HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Genentech, Inc.

http://www.gene.com

Latest From Genentech, Inc.

Biosimilars: US FDA Heralds The End Of Switching Studies For Interchangeability

New guidance suggests that switching studies will no longer be expected as standard to support determinations of biosimilar interchangeability; instead, analytical and clinical data may suffice.

Biosimilars Guidance Documents

First Drug Treatment For Myopia Among 14 New EU Filings

Vyluma’s eyedrop for treating myopia in children and Vertex’s next-generation triple combination treatment for cystic fibrosis are among the latest drugs that the European Medicines Agency has begun reviewing for potential EU marketing approval.

Europe Drug Review

AI and Adverse Events: Tech Not Ready For Prime Time For Case Safety Reports, US FDA Says

FDA leadership weighs in on limitations of AI as part of rollout of new technology meeting program that looks to give industry and other stakeholders a chance to inform future regulation.

Artificial Intelligence Drug Safety

US FDA’s ‘Platform’ Pathway Fits For LNPs And siRNA But Not Delivery Devices

The US FDA’s new guidance defining a “Platform Technology Designation” makes clear that what counts as a “platform” may not match industry’s use of the term.

Guidance Documents Review Pathway
See All

Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Tanox
UsernamePublicRestriction

Register