There is also an Italian presence among the 41 new approvals. It is Bracco which has obtained the OK from the FDA for Lumason (sulfur hexafluoride lipid microsphere), a radiopharmaceutical. However, not all companies celebrated. For example, Pfizer, which has significantly reduced its research budget in recent years, and GlaxoSmithKline also has little to celebrate
Last year, the FDA approved 41 new drugs, the highest level for the agency since 1996, when 53 were approved. The 2014 figure is significantly better than the number of drugs approved by the FDA. agency in 2013, only 29.
To stay on the numbers, the 2014 figure is also clearly higher than the average of the last 10 years (24) , and even of the previous decade, that of the 1990s (31). In short, an excellent fact that we hope will also bode well for the years to come. There are still many pathologies awaiting an effective and safe response.
For Europe, the European Medicines Agency, which also includes generics in its list of new approvals, approved 82 new medicines last year, up from 79 in 2013 and 57 in 2012.
Of the new drugs approved by the FDA last year, nearly 40 percent were treatments for rare diseases, the highest figure ever recorded in the US. Among these drugs are the anti-CD19 antibody blinatumomab (Amgen), which received accelerated approval from the FDA for the treatment of Philadelphia chromosome-negative acute lymphoblastic leukemia and lipodystrophy therapy (metreleptin from Aegerion Pharmaceuticals.
There is also an Italian presence among the 41 new approvals. It is Bracco which has obtained the OK from the FDA for Lumason (sulfur hexafluoride lipid microsphere), a radiopharmaceutical indicated for patients for whom it is difficult to obtain readable echocardiograms with ultrasound alone. Lumason is a contrast medium made up of gas-filled microspheres that reflect sound waves to improve the image and allow the clinician to visualize the patient's heart more clearly. This enables clearer imaging of the left ventricle and endocardium
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