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Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-105

Eton Pharmaceuticals Inc. announced that Aucta Pharmaceuticals Inc.’s New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, was accepted for review by the U.S. Food and Drug Administration.

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Acer Restructures, Eliminates 29 Employees

Two weeks after the U.S. FDA rejected Acer Therapeutics’ New Drug Application for Edsivo (celiprolol), the company initiated a restructuring plan that includes the elimination of 29 employees.

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States Pause Lawsuits Against Insys During Bankruptcy Proceedings

Less than a month after filing for bankruptcy, Insys Therapeutics gained a reprieve from some lawsuits as well as a path forward for regulatory approval of an opioid overdose treatment.

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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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Gilead and Other HIV Treatment-Making Companies Face Class Action Lawsuit

Gilead Sciences has been accused of withholding safer formulations of its HIV drugs in order to maximize profits on those medications that had already been approved, such as Truvada.

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J&J to submit NDAs for at least 10 new drugs by 2023

Johnson & Johnson expects to file marketing applications for at least 10 new drugs between 2019 to 2023, to strengthen the company’s pharma unit which has been a major growth driver.

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Mallinckrodt Completes Enrollment of Phase 3 Terlipressin CONFIRM Trial

Mallinckrodt plc announced that the company achieved target enrollment of 300 participants in the Phase 3 CONFIRM clinical study to evaluate the efficacy and safety of the investigational agent terlipressin in adult patients with Hepatorenal Syndrome Type 1 (HRS-1).

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Alnylam’s RNAi Therapy for Acute Hepatic Porphyria Positive in Phase III

Cambridge, Mass.-based Alnylam Pharmaceuticals indicated that the company’s ENVISION Phase III trial of givosiran was positive for acute hepatic porphyria (AHP).

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Top 10 Pipelines To Watch: 2019 Annual Report

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.

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After Announcing a New CEO, UroGen Touts Positive Phase III Data for Urothelial Cancer

UroGen Pharma announced positive top-line results from the New York based-company’s Phase III OLYMPUS clinical trial that evaluated UGN-101 (mitomycin gel) for instillation for the non-surgical treatment of low-grade upper tract urothelial cancer.

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