BioSpace News Archive

Cytokinetics, Incorporated announced that on March 31, 2023 it granted stock options to purchase an aggregate of 57,600 shares of common stock to 4 new employees, whose employment commenced in March 2023, as a material inducement to their employment.

Hologic, Inc. (Nasdaq: HOLX) announced today that the Company plans to release its financial results for the second quarter of fiscal 2023 on Monday, May 1, after the market closes.

Butterfly Network, Inc. announced today that it has received 510(k) clearance for a groundbreaking AI-enabled Auto B-line Counter that may simplify how healthcare professionals evaluate adults with suspected diminished lung function and can potentially accelerate their ability to make informed treatment decisions at the point of care.

Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today the company completed the enrollment of its 2,000 patient ECLIPSE coronary trial.

Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced the amendment of its exclusive license agreement with Alaunos Therapeutics, Inc. (Alaunos).

Centene Corporation announced that Fred Eppinger will assume the role of Chairman of the Centene Board of Directors, and Wayne DeVeydt will assume the role of Chairman of the Audit and Compliance Committee.

Endo International plc (OTC: ENDPQ) announced today that one of its operating companies, Par Pharmaceutical, Inc., has begun shipping the authorized generic (AG) version of Merck’s Noxafil® (posaconazole) 200 mg/5 mL oral suspension in the U.S.

Astellas Pharma Inc. and Seagen Inc. announced the U.S. Food and Drug Administration has granted PADCEV® with KEYTRUDA® accelerated approval in the U.S. as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible to receive cisplatin-containing chemotherapy.

Merck (NYSE: MRK) today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who are not eligible for cisplatin-containing chemotherapy.

Ur24 Technology, Inc., a privately-held medical device company, has cleared a key hurdle to grow sales of its revolutionary external catheter system, winning approval for Medicare reimbursement for TrueClr products that actively empty a patient’s bladder.