A roundup of the latest news from Spanish pharma, including J&J’s COVID-19 vaccine trial, the latest developments at Spanish firm PharmaMar which hopes its Aplidin can be used as a treatment for COVID-19, and a new biologics plant for contract manufacturer LSNE in the city of León.
Johnson & Johnson Kicks Off Phase 2 COVID-19 Vaccine Trial In Spain (Yahoo Finance)
The first stage of the Phase 2 trial study of J&J’s vaccine, which will be conducted across three hospitals in Spain, is expected to be concluded by Sept. 22.
The pool of volunteers for the trial includes 190 participants, of which La Paz University Hospital’s share will be 50 adults aged 18-55 and 25 seniors aged over 65
PharmaMar breaks its silence on Aplidin: “There are no adverse effects; we are very excited” (CapitalRadio.es (in Spanish))
Company sources say that they do not want to “say anything until they have all the results” but that they are “very excited” with Aplidin and for now “there are no adverse effects”
The redemption of PharmaMar: from hell to heaven in five years (Bolsamania (in Spanish))
When at the end of 2017 the EMA informed PharmaMar that it could not market its compound Aplidin in Europe, many thought it was the beginning of the end for the biotech. The decision sank its titles, as did unfavourable results of its compound lurbinectedin (then Zepsyre and now Zepzelca) in platinum-resistant ovarian cancer patients in early 2018. However, the company has redeemed itself and managed to recover brilliantly, both on the stock market and in terms of meeting its objectives.
Spain reports record rise in coronavirus cases: 10,764 in 24 hours (El Pais)
The coronavirus epidemic in Spain hit a new record on Thursday 10th September with 10,764 cases diagnosed in 24 hours, according to a Health Ministry report.
LSNE-León Receives Approval From AEMPS To Manufacture Biotechnology Based Therapeutic Products (Press Release)
LSNE Contract Manufacturing, a leading contract development and manufacturing organization, is pleased to announce that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the manufacturing of clinical stage biotechnology based therapeutic products at its aseptic fill finish facility in León, Spain