Firm announced on June 19 that its oral osmotic technology will be applied to Glaxo's Ventolin (albuterol) bronchodilator and to Pfizer's Minipress (prazosin) antihypertensive, under joint development agreements with the two pharmaceutical mfrs. Glaxo and Pfizer will make and market the controlled release formulations under a royalty-bearing license from Alza. Pfizer has a similar agreement for an OROS version of the calcium channel blocker Procardia (nifedipine).
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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The European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
The European Medicines Agency recommended against pan-EU marketing authorization of Roche/Sarpeta’s gene therapy Elevidys for the treatment of Duchenne muscular dystrophy as the US reported another death in an Elevidys patient.