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Catalyst Pharma sues FDA over approval of cheaper rival drug

Catalyst Pharmaceuticals Inc., under fire for a high price tag on a rare disease drug, sued the U.S. Food and Drug Administration to challenge the recent approval of a lower-cost rival medicine.

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FDA’s Draft Guidance Proposes Ways to Increase Patient Diversity in Clinical Trials

The U.S. Food and Drug Administration issued a draft guidance on improving the diversity of patient populations in clinical trials.

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Medication-free treatment for depression launches in the UK

Flow, a medical device company, launched a medication-free treatment for depression comprising a brain stimulation headset and therapy app.

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Weekend Highlights from 2019 ASCO Annual Meeting

There was a flurry of activity during the first few days of the American Society of Clinical Oncology, with multiple presentations made showing the benefits of various oncology treatments.

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New Phase 3 Interim Results Support Safety and Efficacy of Diroximel Fumarate in Multiple Sclerosis

New interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that Biogen’s investigational treatment diroximel fumarate was generally well tolerated in people with relapsing MS.

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BioMarin’s Hemophilia A Gene Therapy Shows Promise in Clinical Trial

San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.

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Nektar Forms New Subsidiary

With an opioid molecule awaiting regulatory review, Nektar Therapeutics announced the launch of Inheris Biopharma, which will be responsible for the commercialization of NKTR-181.

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Boehringer Ingelheim Lands Positive Results in Lung Disease Trial

Boehringer Ingelheim’s SENSCIS Phase III clinical trial met the primary endpoint for nintedanib in patients with SSc-ILD.

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AbbVie Halts Brain Tumor Late-Stage Study

AbbVie halted the Phase III INTELLANCE-1 trial of depatuxizumab mafodotin in patients with newly diagnosed glioblastoma whose tumors have epidermal growth factor receptor amplification.

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Agios Pharma’s Tibsovo Shows Positive Results in Phase III for Another Cancer Indication

Cambridge, Mass.-based Agios Pharmaceuticals announced that Tibsovo (ivosidenib) hit the primary endpoint in the Phase III ClarIDHy trial in patients with cholangiocarcinoma with an isocitrate dehydrogenase 1 mutation.

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June 2019 Focus: Payer access, biotech/biopharma, DTC, rare diseases, and more!

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