Emmaus Life Sciences is dusting itself off following the rejection by the European Medicines Agency of the company’s sickle cell disease drug, Xyndari. The company tells the Pink Sheet that it might have better luck in Europe on a country-by-country basis in member states where experts have shown support for its product and where there are many patients with the condition. Not surprisingly, the EMA has defended the system it follows.
Having failed to convince the European Medicines Agency yet again that its sickle cell disease drug, Xyndari, merits pan-EU approval, Emmaus Life Sciences believes it might have more luck by using one of Europe’s regulatory procedures that does not involve the EMA. For its part, the EMA says the company will need new data if it is to succeed.
The US company says it remains baffled as to why the EMA’s drug evaluation committee, the CHMP, decided last month...
<p>Executive Summary</p> <p>A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.</p>
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
It is unclear in a revised staff manual guide whether Commissioner's National Priority Voucher program approval “recommendations” from the drug and biologic center directors will be advisory or decisional, experts told the Pink Sheet.
Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’
Pink Sheet reporter and editors discuss the US FDA’s changes to the COVID-19 vaccine indication and its revocation of the vaccine emergency use authorizations, as well as new vaccine coverage and reimbursement questions.
