Alder BioPharmaceuticals Inc. announced the submission of a Biologics License Application (BLA) to the U.S. FDA for eptinezumab for migraine prevention targeting the calcitonin gene-related peptide (CGRP).
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
AbbVie Inc., along with Teneobio Inc. and that company’s affiliate TeneoOne Inc., announced that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma.
The U.S. FDA approved Cablivi in combination with plasma exchange and immunosuppression for treating acquired thrombotic thrombocytopenic purpura (aTTP) in adults.
Adaptive Biotechnologies announced a worldwide collaboration and license agreement with Genentech – a member of the Roche Group – to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for the treatment of a broad range of cancers.
Morphic Therapeutic has completed a $80 million Series B financing to fund the biotechnology company’s two lead programs through clinical proof of concept, and to advance multiple other programs into the clinic.
The FDA approved Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) to include use in children ages 2-5 years with cystic fibrosis who have two copies of the F508del-CFTR mutation.
Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium – consisting of Imperial College London and the Universities of Oxford and Edinburgh – Imperial Innovations, and Oxford BioMedica announced a global collaboration to develop a first-in-class, long-term therapy for patients with cystic fibrosis.
Anima Biotech announced a deal with Eli Lilly for the discovery and development of translation inhibitors for several target proteins by using Anima’s Translation Control Therapeutics platform.
Scholar Rock – a biotechnology company focused on discovering and developing drugs that selectively target growth factors in the disease microenvironment – announced the publication of “Blocking extracellular activation of myostatin as a strategy for treating muscle wasting,” in Scientific Reports, the peer-reviewed, open-access journal published by Nature.