The U.S. FDA accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1).

The European Commission approved Besponsa as monotherapy for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.

Acorda Therapeutics Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for Inbrija (CVT-301, levodopa inhalation powder). Acorda is developing Inbrija as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa/levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms. The trade name for CVT-301, Inbrija, has been conditionally accepted by the FDA.

Mediktor, a European health technology company, announced the U.S. launch of the first scientifically validated health checker based on artificial intelligence.

FDA approved LivaNova’s VNS Therapy system in patients as young as 4 years of age with partial-onset seizures that are refractory to antiepileptic medications.

Celltrion Inc. and Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration accepted for review the Biologics License Application for CT-P10, a proposed Monoclonal Antibody (mAb) biosimilar to Rituxan (rituximab), which is used to treat patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

Intouch Solutions announced the recent hires of Kim Middleton, senior vice president of client services, and Marc Sirockman, vice president of strategic development.

The U.S. FDA approved Genentech’s Rituxan Hycela (rituximab and hyaluronidase human) for subcutaneous injection for the treatment of adults with certain blood cancers.

There were 580 entries into this year’s Pharma category at Cannes Lions Health. That’s 580 case films accompanied by a slow, heart-wrenching solo piano track that begins with a few spare notes and builds to an optimistic outcome.

Publicis Health’s message delivery businesses announced that Brion Brandes has been named Executive Vice President of Business Development.