Pink Sheet

Biopharma, the White House And Getting Drug Pricing 'Off The Table'

Industry balks at President Trump’s latest effort to force biopharma to negotiate a drug pricing solution, but investors may be pushing for concessions that could head off more onerous policies supported by a Biden White House.

Topic US Election 2020 Drug Pricing Regulation

Pink Sheet

UK Votes To Leave The EU – Where Next For The Life Sciences?

UK vote to leave the EU opens the prospect of years of negotiations over the union's future relationship with one of its most valued member states.

Topic Regulation Brexit BioPharmaceutical

Medtech Insight

UKCA Mark Will Be The Post-EU Route To The British Medtech Market In January 2021

New MHRA guidance says the EU CE marking will continue to be used for devices and diagnostics in Great Britain until June 2023, and thereafter a standalone regulatory system will come into place.

Topic Medtech-Brexit Regulation

Medtech Insight

Brexit Response: Patient Safety Prioritized In Forthcoming UK MHRA Device Regulatory System

Although the EU MDR and IVDR will fall outside the scope of new post-Brexit medtech regulations for Great Britain in 2021, the UK MHRA says it has the chance of developing its own world-leading regulatory regime.

Topic Medtech-Brexit Regulation Brexit

Pink Sheet

Gloom Over Prospects For Brexit Trade Deal

With time running out on the UK-EU trade deal negotiations, the UK life sciences industry looks at the fine print of the new guidance on medicines regulation and explains why a mutual recognition agreement is urgently needed. 

Topic Pharma-Brexit Regulation Brexit

Chemist + Druggist Data

UK Sees PIP Codes Expand To Cover Hospital Drugs

Chemist + Druggist has expanded its “PIP code” system for UK pharmacy procurement to also encompass hospital drugs.

Topic BioPharmaceutical Regulation Biosimilars

Pink Sheet

China Regulatory Express Former CFDA Commissioner Bi Makes Comeback

Ex-China FDA Commissioner Bi Jingquan’s new role, a waiver of bioequivalence testing for hundreds of drugs, data accuracy requirements and a new crackdown on compliance issues.

Topic China Regulation Compliance

Pink Sheet

Stephen Lightfoot Appointed New Chair Of UK MHRA

The former industry executive and incoming MHRA chair says he wants to see the agency become an “enabler” in the UK health system. Meanwhile, the MHRA is still looking for a permanent chief executive after Ian Hudson stepped down from the post nearly a year ago.

Topic Regulation BioPharmaceutical

Medtech Insight

All About Value – Brexit Aside, UK Industry Sees Good Things Ahead For Healthtech Adoption

ABHI director of value and access Luella Trickett talks about the importance of real-world evidence in product development and value-based procurement in secondary care in the UK.

Topic Medtech-Brexit EU Legislation Regulation