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EU Authority Mulls Paying For  Late-Stage Research As A Pull Incentive For Neglected Disease Drugs

EU Authority Mulls Paying For Late-Stage Research As A Pull Incentive For Neglected Disease Drugs

It is time for a much greater focus on pull incentives to ensure viable market conditions for medicines for neglected diseases that are traditionally regarded as unprofitable.

Manufacturers Eye Challenges Of Broadening Cell And Gene Therapy Access

Manufacturers Eye Challenges Of Broadening Cell And Gene Therapy Access

With more advanced therapies gaining approval, companies at ARM’s Cell and Gene Meeting on the Mesa considered hurdles to making their products more broadly available and developing them for larger indications.

GSK’s Arexvy Reinforces Its Lead In A Stalling RSV Vaccine Market

GSK’s Arexvy Reinforces Its Lead In A Stalling RSV Vaccine Market

Arexvy has become the first RSV vaccine to show it can provide protection over three years – but that might mean lower market uptake than originally expected.

The ‘Unintended Consequences’ Of UK's New Pricing Scheme

The ‘Unintended Consequences’ Of UK's New Pricing Scheme

Issues raised in the first six months of the new VPAG include potential adverse impacts on both older and newer innovative drugs, as well as uncertainties over the “exceptional circumstances” clause that allows requests for price increases or cuts in repayment rates.

Gilead Seals VLs For Lenacapavir Amid Concerns Around Price, API Supplies

Gilead Seals VLs For Lenacapavir Amid Concerns Around Price, API Supplies

Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.

Humira Pricing Takes Center Stage In Dutch Courts

Humira Pricing Takes Center Stage In Dutch Courts

A public interest group has accused the pharma major of using excessive pricing to bolster sales of blockbuster Humira, consequently damaging the health of Dutch patients. 

UK Gets Behind PIM Database Plan And Tools For Improved NHS Medtech Adoption

UK Gets Behind PIM Database Plan And Tools For Improved NHS Medtech Adoption

Innovation in life sciences and UK NHS adoption of technology are high on UK’s political agenda in the post-election period. Projects at the MedTech Directorate and NICE, and support from the Office for Life Sciences, are playing into a renewed sense of optimism.

Gilead Seals VLs For Lenacapavir Amid Concerns Around Price, API Supplies

Gilead Seals VLs For Lenacapavir Amid Concerns Around Price, API Supplies

Gilead strikes voluntary licensing agreements with six generic manufacturers for lenacapavir but health groups seek clarity on pricing and seeming API supply restrictions. All eyes are also on the patent opposition case in India.

EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group

EU HTA Regulation: ‘We Don’t Want An Empty Dossier,’ Warns Coordination Group

Manufacturers that do not answer all questions they are asked during joint clinical assessments under the upcoming EU HTA Regulation could have their applications deemed incomplete, says a co-chair of the JCA subgroup.

Gene Therapy Hemgenix Gains Ground In Europe With Spanish Reimbursement Deal

Gene Therapy Hemgenix Gains Ground In Europe With Spanish Reimbursement Deal

Hemgenix has now secured reimbursement in several European markets, with more talks ongoing. While the path to reimbursement has not always been easy, innovative access deals have helped to smooth the way.