Abbott announces CE Mark and first use of the world's first smartphone compatible insertable cardiac monitor
Abbott (NYSE: ABT) today announced CE Mark and first use of the new Confirm RxTM Insertable Cardiac Monitor (ICM), the world's first smartphone compatible ICM that will help physicians identify difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), to help guide therapy. Since CE Mark approval, adoption of the device has been strong and implants have occurred in 10 countries across Europe. 
Pfizer Inc. (NYSE:PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of BESPONSA® (inotuzumab ozogamicin) in the European Union (EU) as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL) and Philadelphia chromosome positive (Ph+) ALL, who have previously failed treatment with at least one tyrosine kinase inhibitor (TKI). 
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the European Medicines Agency (EMA) has granted orphan designation to inebilizumab (formerly MEDI-551) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Developed by MedImmune, inebilizumab is currently in Phase IIb clinical development for NMOSD. 
Novartis announced the European Commission has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC). The approval marks the first targeted treatment approved for the patient population, who previously had few treatment options, in all 28 member states of the European Union (EU), plus Iceland and Norway.