Pharmaceutical companies, NGOs, and patient organizations were among the 129 respondents to the European Commission’s consultation on its draft implementing act for joint clinical assessments – but opinions on the proposal were divided.
The European Commission’s proposed implementing act for EU-level joint clinical assessments (JCAs), a key element of the upcoming Health Technology Assessment Regulation ((EU) 2021/2282), has been described as “unworkable” by the pharma industry.
The European Association for Bioindustries (Europabio), for example, said it was concerned that the commission’s proposal for implementing JCAs, which...
Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.
The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.
Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Chiesi’s orphan drug Raxone has secured an English funding recommendation for the treatment of Leber's hereditary optic neuropathy, a decade after the orphan drug was approved for marketing. Chiesi told the Pink Sheet about its “long, and often challenging” road to reimbursement.
