May 2016

Ibrutinib is a drug for the treatment of rare diseases. It has been approved for the treatment of adults with chronic lymphocytic leukaemia (CLL) or with relapsed or refractory mantle cell lymphoma (MCL) since 2014, and since 2015 also for the treatment of adults with Waldenström macroglobulinaemia. Regarding the treatment of patients with CLL or MCL, the Federal Joint Committee (G-BA) already conducted a benefit assessment and made a decision in 2015.

In a study of nearly 650 people with the eye disease age-related macular degeneration (AMD), half still had vision 20/40 or better, typically good enough to drive or to read standard print, after five years of treatment with anti-VEGF drugs that are injected into the eye. The authors of the study, funded by the National Eye Institute (NEI) at the National Institutes of Health, say those outcomes would have been unimaginable about 10 years ago, prior to the drugs’ availability.

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion, recommending the approval of a new antibiotic, CAZ AVI 2g/0.5g powder.

Flamel Technologies announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s New Drug Application (NDA) for Akovaz™ (ephedrine sulfate), a drug administered parenterally as a pressor agent to address clinically important hypotension in surgical settings.

Oncurious NV, an emerging oncology company focused on the development of innovative orphan drugs for the treatment of pediatric cancers, announces it has initiated a Phase I/IIa study that will evaluate the safety and tolerability and explore the preliminary efficacy of TB-403 for the treatment of relapsed or refractory medulloblastoma, a rare, life-threatening brain tumor that mainly affects children.

Teva Pharmaceutical Industries Ltd., announced that the U.S. Food and Drug Administration (FDA) has approved ProAir RespiClick^® (albuterol sulfate) Inhalation Powder for the treatment or prevention of bronchospasm in children 4 to 11 years of age with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB)

Researchers have learned new information about how different people respond to aspirin, a globally prescribed drug in cardioprotection. The research team, led by scientists at Cardiff University in the United Kingdom and including representatives from the University of Alabama at Birmingham and the University of Colorado, identified more than 5,600 lipids  or fats in blood platelets and gained new insights into how these cells respond to aspirin.