As data start to come in on the first coronavirus vaccines, hopes are rising that vaccination campaigns will be able to begin in the next month or two, although experts have cautioned against unbridled optimism. Uncertainties also remain over questions such as whom to vaccinate first and how to assure equitable access in less wealthy parts of the world.
It has been quite a week for makers of candidate COVID-19 vaccines.
On Monday, Pfizer Inc
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While drug companies say they support the European Medicines Agency’s expanded OPEN framework for the collaborative assessment of marketing applications with non-EU authorities, they are reluctant to participate in the initiative for a number of reasons.
The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.
In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.
A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.
