DUBLIN – Shares in Bavarian Nordic A/S surged 35 percent Wednesday on news of a $975 million option and licensing deal with Bristol-Myers Squibb Co. involving its prostate cancer vaccine Prostvac. New York-based BMS is paying $60 million up front and could pay up to $935 million more in milestones linked to the progress of the immunotherapy, which is currently undergoing a phase III trial in 1,200 patients with metastatic castration-resistant prostate cancer (mCRPC).
DUBLIN – Suppremol GmbH is joining the nascent Baxalta organization in a €200 million (US$221 million) acquisition deal that signals the intentions of the Baxter Bioscience spinout to extend its scientific capabilities and its pipeline into autoimmune disease.
DUBLIN – A newly published analysis from Germany's main health technology assessment agency, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG), concluded that the benefit assessment process Germany introduced for new drugs in 2011 has narrowed the information gap on new medicines and provided a fuller understanding of their benefits and risks than that available from other regulatory and academic sources.
DUBLIN – Funding continues to flow to European biotech, with Cardio3 Biosciences SA and Quantum Genomics SA raising €32 million (US$36 million) and €12.9 million (US$14.44 million), respectively, in secondary offerings last week. Both transactions confirm the current appetite among investors for European biotech, but a much sterner test of that support is on the near-term horizon, as a new Irish-American firm Malin Corp. plc unveiled ambitious plans to raise €275 million to €325 million in an IPO in Dublin shortly.
DUBLIN – Prexton Therapeutics SA, an early stage CNS drug developer spun out of the Merck Serono arm of Merck KGaA, raised €8.7 million (US$10 million) to move a metabotropic glutamate receptor 4 (mGluR4) agonist development program into clinical trials in Parkinson's disease.
DUBLIN – Pharmaceutical firms operating in Europe are breaching on a weekly basis their own voluntary code for regulating drug promotion, according to a recently published analysis, which calls for tougher financial penalties, stricter monitoring of drug companies' behavior and public naming and shaming of offenders.
DUBLIN – Sanofi SA has teamed up with a little-known Dutch biotech company, Lead Pharma Holding BV, in order to move into the hotly contested arena of retinoic acid-related orphan receptor gamma-t (RORγt) inhibition.
DUBLIN – As bureaucratic climbdowns go, it was pretty humiliating. The EMA has conceded to the European Ombudsman that it had no justification for a large chunk of the redactions it performed on clinical data it released to a third party under the EU's access-to-documents rules.
