Following a request from Denmark, the European Medicines Agency has begun a review of the safety of the human papillomavirus vaccines Gardasil and Cervarix to find out whether or not reports of two rare adverse events are linked to the vaccines.
ReNeuron Plc has outlined a three-year plan for the development of its stem-cell therapy portfolio that would, if successful, lead to regulatory applications for products in both stroke and retinitis pigmentosa. To support this development, it is proposing to raise £68.4 million in a share placement.
Autifony Therapeutics Ltd has obtained an additional £8 million in funding to expand the potential for its potassium channel modulator technology beyond hearing disorders, to schizophrenia and other indications.
A France-based microbiome company has raised €2 million in a Series A financing to develop two new compounds with the potential for targeting bacteria that are resistant to current antibiotics. Seventure Partners is providing the capital to Eligo Bioscience SAS.
Premaitha Health Plc, which has a prenatal test for assessing the risk of Down’s syndrome and other genetic defects, has raised £8 million from a placement of new shares on the AIM section of the London Stock Exchange.
4SC AG has secured funding for the further clinical development of its histone-deacetylase (HDAC) inhibitor resminostat enabling it to take the compound through a Phase 2 and pre-registration trial in patients with cutaneous T cell lymphoma (CTCL).
Denmark-based Bavarian Nordic A/S has received a $133 million order for the supply of its Imvamune smallpox vaccine to the US government for stockpiling in case of a biological emergency. The new order is an extension of an existing contract.
Vertex Pharmaceuticals Inc has won approval in the US for a second drug to treat cystic fibrosis, this time for a treatment targeting the F508del mutation, the most common cause of the disease. Called Orkambi (lumacaftor/ivacaftor), the drug is indicated for patients who have two copies of the mutation.
A public US share offering of Pieris Pharmaceuticals Inc (formerly Pieris AG) has raised a gross amount of $25 million following the sale of 9,090,909 new shares to international investors. The net proceeds are expected to be $22.7 million.
Biogen Inc has thrown its weight behind gene therapy with a decision to invest potentially $1 billion for rights to an early clinical, and a host of pre-clinical and discovery gene therapy assets directed at ophthalmic diseases and one non-ophthalmic condition.