DUBLIN – The EMA had three big wins this week in the Court of Justice of the European Union, which has upheld its transparency policy and thrown out legal challenges from PTC Therapeutics Corp., the animal health arm of Merck & Co. Inc., and Pari Pharma GmbH. All of the companies were ordered to pay the agency's costs, as well as their own. In addition, EUCope, a Brussels-based lobby group for midsized pharma and biotech firms, which was supporting PTC's action, was also ordered to pay its own costs.
DUBLIN – Syndesi Therapeutics SA, a newly formed UCB SA spinout, closed €17 million (US$21.2 million) in a series A round to take forward a novel series of synaptic vesicle protein 2A (SV2A) modulators for treating dementia.
DUBLIN – Aicuris Anti-infective Cures GmbH banked a €30 million (US$37.3 million) milestone from partner Merck & Co Inc. following formal European approval of Prevymis (letermovir) for preventing reactivation of cytomegalovirus (CMV) infection in seropositive bone marrow transplant patients.
DUBLIN – With its future headquarters in Amsterdam not due to be ready until November 2019, the EMA unveiled the temporary building it will start to transition to from Jan. 1, 2019, during a press briefing in Amsterdam Monday. The interim premises, the Spark Building, based in the Sloterdijk area northwest of Amsterdam's center, offers just half of the space of its present headquarters in the Canary Wharf district in east London.
DUBLIN – Merck & Co. Inc., Roche Holding AG, Chiesi Farmaceutici SpA and Glaxosmithkline plc entered the winners' enclosure following the monthly meeting of the EMA's Committee for Human Medicinal Products (CHMP) in London this week.
DUBLIN – Shares in Santhera Pharmaceuticals Holding AG dropped as much as 33 percent Wednesday on news that it expected its appeal against a negative opinion on the European approval of its Duchenne muscular dystrophy (DMD) drug Raxone (idebenone) to be unsuccessful.
DUBLIN – The epic CRISPR/Cas9 patent wars took another intriguing twist this week, when the European Patent Office (EPO) revoked a Broad Institute European patent, EP 2771468 B1, on the basis that it lacked priority over novel art. The Broad Institute, of Cambridge, Mass., immediately stated its intention to appeal the decision, which imposes a stay of execution on the EPO decision.
DUBLIN – The twin phenomena of protein aggregation and deposition have been viewed almost exclusively through a pathology lens. The amyloid hypothesis in Alzheimer's disease – still not conclusively proven in clinical settings but by no means refuted either – is the most prominent example in human biology.
DUBLIN – Oxford University spinout Vaccitech Ltd. raised £20 million (US$27.3 million) in a series A round that will enable it to complete an ongoing phase IIb trial of a universal influenza vaccine and a phase II trial of a therapeutic prostate cancer vaccine within the next two years.
