EMA gives green light for 8 new medicines

The European Medicine Agency’s key decision-making committee on human medicines (CHMP), has recommended eight medicines for approval at its June meeting.  The Committee recommended granting a conditional marketing authorisation for Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, and whose cancer has worsened since receiving the last treatment. […]

EMA reports big wins for small pharma

The success rate for marketing authorisation applications for small and medium-sized enterprises (SMEs) has doubled between 2016 and 2020, according to the European Medicines Agency (EMA). In 2016, 40% of medicines with an SME applicant received a positive opinion. In 2020, the number had increased to 89%. In 2020 alone, SMEs were behind 16 recommendations for approval of a new […]

Dessicated liposome technology improves vaccine stability

Mountain Valley MD, Ontario, Canada The results of the first study to evaluate the stability of Trivalent Inactivated Poliovirus Vaccine (tIPV) formulated in desiccated liposomes (QuIcksometm) has yielded promising results. The technique involves laying down a film of desiccated liposomes containing the vaccine in a vial. The vaccine is the reconstituted using Water for Injection at the point of administration. […]