In the bitter political battle over a potential replacement for the Affordable Care Act, common ground between rivals can seem scarce. Yet, right there in the middle is one of the top priorities across parties: lowering the cost of prescription drugs.

Ongoing market access barriers for U.S. pharma and medical device companies landed India, Canada and Colombia on the U.S. Trade Representative's annual "Special 301" watch list again. The USTR's annual report reviews global developments on trade and intellectual property, identifying trading partners that USTR, part of the Executive Office of the President, deems to have harmful records on protection, enforcement or market access for U.S. innovators and creators.

Ongoing market access barriers for U.S. pharma and medical device companies landed India, Canada and Colombia on the U.S. Trade Representative’s annual “Special 301” watch list again.

Takeda Pharmaceutical Co. Ltd. subsidiary Ariad Pharmaceuticals Inc. won accelerated approval from the FDA for Alunbrig (brigatinib). The approval covers the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) who have progressed on or are intolerant to Pfizer Inc.’s Xalkori (crizotinib).

FDA approval has arrived for Novartis AG's Rydapt (midostaurin), a breakthrough-designated treatment for adults with newly diagnosed FLT3-mutated acute myeloid leukemia (AML). The oral, multitargeted kinase inhibitor, approved for use in combination with chemotherapy and a companion diagnostic developed by Invivoscribe Technologies Inc. to detect the FLT3 mutation, is the first targeted therapy to treat patients with AML.

Biomarin Pharmaceutical Inc. has won FDA approval for Brineura (cerliponase alfa), the first therapy for children with the rare and fatal neurodegenerative condition ceroid lipofuscinosis type 2 (CLN2). The enzyme replacement therapy was approved to slow the loss of walking ability in symptomatic children, 3 years and older, with the late infantile form of the condition.

Arsanis Inc., an infectious disease specialist developing a targeted monoclonal antibody to prevent Staphylococcus aureus pneumonia, has closed on a $45.5 million series D financing that will help it complete a phase II trial of candidate ASN-100 in high-risk mechanically ventilated patients. The new funds will also support the advancement of preclinical gram-negative programs, as well as a respiratory syncytial virus (RSV) program.

AMSTERDAM – Hepatitis B treatment guidelines, newly updated by the European Association for the Study of the Liver to help doctors navigate what EASL governing board member Frank Tacke told BioWorld Today is "lots of dynamic change" during the last couple years, have become the first to recommend the use of the most recently approved HBV drug, Vemlidy.

Patients with Duchenne muscular dystrophy (DMD) and advanced heart disease enrolled in an exploratory study of Capricor Therapeutics Inc.'s candidate, CAP-1002, saw, at the study's six-month midpoint, improved measures of cardiac structure and upper limb function. The interim data suggest that the therapy, composed of allogeneic cardiosphere-derived cells, could help stave off decompensated heart failure, a common cause of death for individuals with DMD.