BioSpace News Archive

Topline results for its Daiichi Sankyo-partnered antibody-drug conjugate showed statistically significant improvement. However, AstraZeneca shares dropped around 6% in early Monday trading.

Pharmas, advocacy groups and regulatory bodies have made moves to put each other in legal crosshairs in 2023. Follow along with BioSpace’s Lawsuit Tracker to see what’s piling up on the docket.

The verdict, rendered by a California jury on Friday, found that the companies did not engage in an anticompetitive conspiracy to delay generic versions of HIV PreEP medicines.

After initial Phase II data for the oral IL-23 receptor antagonist licensed from Protagonist Therapeutics spooked investors, Janssen provided a fuller readout and advanced the candidate.

AbbVie’s Humira will now face competition from new biosimilars, including Boehringer Ingelheim’s Cyltezo, Celltrion’s Yuflyma, Organon and Samsung’s Hadlima, and Sandoz’s Hyrimoz.

Nevakar Injectables Inc. announced today that the U.S. Food and Drug Administration (“FDA”) has approved its new drug application (“NDA”) for Cyclophosphamide Injection, 200mg/mL vials for use in combination therapy for various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia.

Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that it has raised $25 million at-the-market from select existing investors, primarily to fund initiation of the Company’s launch preparations in anticipation of the EB-101 Biologics License Application (BLA) submission and potential approval.

Prime Therapeutics LLC announced that Mostafa Kamal will succeed Ken Paulus as President and CEO of Prime Therapeutics.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the launch of its authorized generic for Xyrem®1 (Sodium Oxybate) oral solution CIII in the United States.

Timber Pharmaceuticals, Inc. announced that on June 28, 2023 it received a letter from the NYSE American LLC advising the Company is not in compliance with the NYSE American continued listing standards set forth in Sections 1003 and of the NYSE American Company Guide given the reported stockholders’ deficit as of March 31, 2023, and losses from continuing operations and/or net losses in its four most recent fiscal years then ended.