For the first time, two patients suffering from a rare genetic blood disorder, for which there is currently no approved medicine, participated in a discussion at the main scientific committee of the European Medicines Agency where a candidate medicine for their disease was being reviewed.
The European Medicines Agency has given positive opinions for 15 new medicines including treatments for hepatitis C infection, Cushing’s syndrome and for non-small cell lung and gastric cancers. The decisions were announced on 26 September.
Adaptimmune Ltd, which is developing a T cell therapies for cancer and infectious disease, has raised $104 million in a Series A financing round to support its ongoing work in multiple cancer indications. The oversubscribed round was led by New Enterprise Associates of the US.
Probiodrug AG, a German specialist in Alzheimer’s disease, is planning to make an initial public offering of its shares on the Amsterdam Euronext exchange to support development of a drug that targets small amyloid-beta aggregates.
A candidate treatment for patients with glaucoma, Vesneo, has reached its primary endpoint in a Phase 3 development programme, showing that it can effectively lower intraocular pressure, according to Nicox SA, the developer.
Shire Plc said that it has reached agreement with the US government to pay $56.5 million in fines to settle a civil investigation relating to its sales and marketing practices for three medicines for attention deficit hyperactivity disorder and two for ulcerative colitis.
Regeneron Pharmaceuticals Inc is to appeal against a decision of the European Patent Office (EPO) to revoke its patent for transgenic mouse technology, a patent that was successfully challenged by Kymab Ltd of the UK.
Merck KGaA has become the second large German pharmaceutical company to reconfigure its profile with the acquisition of Sigma-Aldrich Co for $17 billion. The deal, announced on 22 September, has been approved by the boards of both companies.
CureVac GmbH, a pioneer in RNA technology, is set to work with Boehringer Ingelheim on two new oncology projects that will seek to improve outcomes for patients with non-small lung cancer by leveraging existing treatments with a cancer vaccine.
Kymab Ltd has successfully challenged a European patent issued to its competitor, Regeneron Pharmaceuticals Inc, for transgenic mouse technology that is a foundation for developing therapeutic antibodies. The patent was said to lack an inventive step as required by European patent law.