The latest BTD was granted for the treatment of adult patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have not received prior treatment with an ALK inhibitor.
Encouraged by evidence of the impact that its diabetes drug semaglutide can have on obesity, with patients shedding an average of 16% of their weight in a mid-stage study, top researchers at Novo Nordisk today unveiled an ambitious late-stage strategy to make their mark in a tough, but potentially blockbuster market.
Celgene Corporation and bluebird bio, Inc. announced that bb2121, a chimeric antigen receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) eligibility by the European Medicines Agency (EMA).
Sangamo Therapeutics, Inc. (SGMO) today announced treatment of the first patient in the Phase 1/2 clinical trial ("the CHAMPIONS study") evaluating SB-913, an investigational in vivo genome editing therapy for people with mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome.
Novartis’s bid to move in on Bayer’s and Regeneron’s eye-drug turf was buoyed on Friday by data showing patients on the Swiss drugmaker’s new RTH258 drug showed less disease activity than those on its rivals’ drug Eylea.
To expedite its push into mobile health, Yardley, Pennsylvania-based StayWell announced today that it has acquired the mobile health portion of Silicon Valley-based MedHelp, which includes several consumer-facing mobile health apps.
CVS Health Corp.’s bid for Aetna Inc., which could be valued at more than $66 billion, would — if successful — combine two businesses that have traditionally been separate, health insurance and pharmacy-benefit management.
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