HAMBURG – The EMA is still waiting on a report from the French regulator Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM), in the wake of the clinical trial disaster involving painkiller BIA10-2474, which Porto, Portugal-based Bial Portela & CA was developing.
STOCKHOLM – The academic-industry interface emerged as a significant topic during discussions on day two of the BIO-Europe Spring meeting. And while one session focused on the perceived failings of academia – particularly Europe's universities and the surrounding innovation ecosystem – a later session on early stage drug development provided a salutary reminder that industry also has plenty of shortcomings to address if the drug development process is to become more efficient.
STOCKHOLM – After its fall meeting in Germany, EBD Group's BIO-Europe spring partnering meeting normally heads south to the warmer climes of Spain or Italy. This year, however, it headed north to Stockholm, where spring is still more a suggestion than a reality.
DUBLIN – Amryt Pharmaceuticals plc, a recently formed specialty pharma company with a focus on orphan diseases, is gaining a listing on London's AIM through a reverse takeover of the former oil and gas exploration firm Fastnet Equity plc, of Dublin, in a deal valued at £29.6 million (US$42.6 million). At the same time the Dublin-based company is raising £10 million in new funding and acquiring two European specialty pharma firms, Birken AG and Sompharmaceuticals SA, for a combination of cash, including milestone-based payments, and shares.
DUBLIN – Finnish start-up Medicortex Finland Oy is taking on one of the biggest challenges in medicine, the diagnosis and treatment of traumatic brain injury (TBI), with a two-pronged strategy based on the identification and validation of a novel biomarker and on the development of a therapeutic that bundles several mechanisms of action into a single molecule.
DUBLIN – Vectura Group plc is acquiring Skyepharma plc in a deal that values the latter firm at £441.3 million (US$622 million) or 410.15 pence per share. The transaction will create a U.K.-based respiratory drug delivery specialist with pro forma annual revenues of £153.9 million and with a position in each of the industry's three key technology areas: dry powder inhalers, pressurized metered dose inhalers and nebulizers.
DUBLIN – Etherna Immunotherapies NV raised €24 million (US$26.6 million) in a series A round to take forward an mRNA-based cancer vaccine technology that has already delivered clinical proof-of-concept data.
DUBLIN – Shares in GW Pharmaceuticals plc surged more than 130 percent in London on Monday on news that Epidiolex (cannabidiol) met the primary endpoint of a pivotal phase III trial in Dravet syndrome, a rare and severe form of treatment-resistant epilepsy that emerges in infancy.
DUBLIN – Aprea AB raised €46 million (US$50.7 million) in a series B round that will fund a phase IIb trial in ovarian cancer of its first-in-class p53 reactivator APR-246, as well as a series of exploratory trials in several other oncology indications in which p53 mutations are implicated. The compound works by stabilizing the conformation of p53 proteins with point mutations in the DNA binding domain and has already generated promising clinical data as monotherapy and in combination with chemotherapy.
