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Baxter Announces FDA Approval of Myxredlin, the First and Only Ready-To-Use Insulin for IV Infusion

Jul 23, 2019
Baxter International Inc. announced the U.S. Food and Drug Administration (FDA) approval of Myxredlin (Insulin Human in 0.9% Sodium Chloride Injection). Myxredlin (pronounced…
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Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in…

Jul 23, 2019
Sandoz, a Novartis division and a global leader in biosimilars, announced the first patient enrolled in ROSALIA, an integrated Phase I/III clinical study for its proposed biosimilar…
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ACADIA Pharmaceuticals Announces Top-line Results from Phase 3 ENHANCE Trial of Pimavanserin

Jul 23, 2019
ACADIA Pharmaceuticals Inc. announced top-line results from its Phase 3 ENHANCE study, which evaluated pimavanserin as an adjunctive treatment in adult schizophrenia patients with…
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Vertex Submits New Drug Application to the FDA for Triple Combination Regimen of VX-445…

Jul 23, 2019
Vertex Pharmaceuticals Incorporated announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the VX-445 (elexacaftor), tezacaftor and…
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FDA Approves OTEZLA (apremilast) for the Treatment of Oral Ulcers Associated with Behçet’s Disease

Jul 22, 2019
Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has approved OTEZLA (apremilast) 30 mg twice daily (BID) for the treatment of adult patients with oral…
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Three Interactive Sessions to take place at the Respiratory Drug Delivery Conference

Jul 19, 2019
SMi Reports: The 2019 Respiratory Drug Delivery conference to host three interactive sessions this December. The Respiratory Drug Delivery, taking place in London on 5th-6th…
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Celltrion and Nan Fung Group to establish Vcell Healthcare Limited to Develop and Commercialize…

Jul 19, 2019
Celltrion and Nan Fung Group announced the establishment of Vcell Healthcare Limited, a Joint Venture company between both parties. At the formation of the Joint Venture, Vcell…
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Aridis Receives Orphan Drug Designation From the European Medicines Agency for AR-501

Jul 19, 2019
Aridis Pharmaceuticals, Inc. announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation to AR-501, the Company's inhaled formulation of gallium citrate for…
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Janssen Seeks EMA Approval for Novel Subcutaneous Formulation of DARZALEX (daratumumab)

Jul 19, 2019
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of an extension application to the European Medicines Agency (EMA) for subcutaneous (under the…
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MilliporeSigma and Broad Institute Announce CRISPR License Framework to Encourage Innovation

Jul 19, 2019
MilliporeSigma and the Broad Institute of MIT and Harvard announced an agreement to offer non-exclusive licenses to CRISPR intellectual property (IP) under their respective control for…
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