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Market Access & Reimbursement

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Pharmacists To Get New Substitution Powers To Tackle Brexit Shortage Risk

In an effort to address possible serious drug shortages in the event of a no-deal Brexit, the UK government has formally proposed giving pharmacists wide powers to dispense alternative medicines such as different forms, generics, biosimilars, or “therapeutically equivalent” drugs.
Brexit United Kingdom

Bio Industry Warns UK Orkambi Inquiry Against Publishing Confidential Price Information

Vertex and bioindustry groups have called on a UK inquiry investigating the availability of the cystic fibrosis drug Orkambi on the National Health Service not to publish confidential information.

Europe United Kingdom

Mexican Pharma Industry Joins Anti-Corruption Crackdown

The Mexican research-based pharmaceutical industry has pledged to crack down on corruption as the country’s new president says the vice must be eliminated to deliver better health system.

Mexico Government Payers

UK’s NICE Under Fire For New HTA Fees

Fees for appraisals that the health technology assessment body, NICE, will introduce in April could adversely impact companies with medicines for smaller indications, despite a bigger fee reduction for some manufacturers.

Europe United Kingdom

EMA Wants Stakeholder Input On Regulatory Challenges To 2025

The EMA has launched a six-month consultation on the challenges facing the agency and the wider EU regulatory network in the face of emerging scientific and technological advances, and has put forward a range of recommendations for action in the period to 2025 to ensure the regulatory system is fit for purpose.
Regulation Europe

Biogen Pours Cold Water On Cross Country Spinraza Pricing Talks With Norway And Denmark

Biogen is reluctant to enter joint talks with Norway and Denmark over Spinraza, but expects cross country pricing and reimbursement collaboration could become a fixture.

BioPharmaceutical Europe
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