An antibody checkpoint inhibitor has become the first drug to be approved in the US for Merkel cell carcinoma, an aggressive form of skin cancer where fewer than half of patients survive more than one year.
Two years after launching in Europe, the Parkinson’s disease drug Xadago (safinamide) has been approved in the US as an add-on treatment to the combination therapy levodopa/carbidopa. The new approval means it will be available in both regions for treating symptoms of the disease such as tremor and impaired mobility.
President Donald Trump announced on 10 March that he intends to nominate Scott Gottlieb as head of the Food and Drug Administration. Mr Trump has chosen a medical doctor with considerable experience in the politics of medicine, often arguing on television and in print that increasing competition is the way to deal with the medical industry’s complex problems.
Denmark-based ALK-Abelló A/S is preparing for an expansion of its business in the US following the Food and Drug Administration’s approval on 1 March of its allergy immunotherapy tablet Odactra for adults with house dust mite allergies.
The European Medicines Agency is recommending approval of Natpar (parathyroid hormone) to treat patients with chronic hypoparathyroidism who require more than calcium and vitamin D. If approved by the European Commission, Natpar would be the first hormone replacement therapy for this condition.
The US Food and Drug Administration has approved the monoclonal antibody brodalumab to treat adults with moderate-to-severe plaque psoriasis, an autoimmune disorder that causes patches of redness and flaking on the skin.
The coming into force next year of new European rules governing clinical trials will simplify trial application procedures and make more study information available to the public. At a meeting of the European Forum for Good Clinical Practice on 22 February, healthcare professionals discussed how the new rules on transparency should build public confidence in the regulatory system and avoid potentially serious accidents.
The Food and Drug Administration has approved a second drug for the treatment of Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes a progressive deterioration of muscle. The treatment is a corticosteroid called Emflaza (deflazacort) that works by decreasing inflammation and reducing the activity of the immune system.
With the UK government on course to begin the legal process for leaving the EU, industry leaders have spoken openly about the impact. In separate teleconferences, the CEOs of AstraZeneca Plc and GlaxoSmithKline Plc (GSK) said the EMA would almost certainly have to re-locate.
Ingmar Hoerr, chief executive of CureVac AG, has been appointed as one of 15 members of a new group that will advise the European Commission on strengthening the environment for research and innovation in the European Union.