The Pink Sheet’s list of EU centralized approvals of new active substances now includes three new products including Lusutrombopag Shionogi for treating severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
Lusutrombopag Shionogi (lusutrombopag) is among the three new additions to the Pink Sheet's regularly updated list of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure. The other two new additions are Rizmoic (naldemedine) and Besremi (ropeginterferon alfa-2b).
The great majority of new, innovative medicines and vaccines that are marketed in the EU go through the centralized procedure....
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.
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.
AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.
The findings are consistent with some other research and likely are due to obesity patients becoming more connected to needed health care services.
