BioSpace News Archive

OMX, Axial, KDT and Civilization Ventures join round

Harrow (Nasdaq: HROW) today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL, a synthetic corticosteroid indicated for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids as well as visualization during vitrectomy.

Xellia Pharmaceuticals, a global leader in the manufacturing of specialty anti-infective treatments and critical care therapies, has received approval by the US FDA for the manufacture of its first premix bag products at its facility in Cleveland, Ohio, USA.

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced a change in management.

Sequana Medical NV, a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, announces that all three patients from the non-randomized cohort of the MOJAVE study were successfully treated with DSR 2.0.

PlaqueTec, a company identifying endotype-specific biomarkers to advance precision medicine for coronary artery disease, announced that it has received the UK’s Medicines and Healthcare products Regulatory Agency approval to continue its BIOPATTERN trial following recruitment of the first ten patients with CAD.

Cerevel Therapeutics announced it will host a tavapadon investor webcast on Monday, December 11, from 10:00 to 11:30 a.m. ET.

BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the National Administration of Drugs, Foods, and Medical Devices (ANMAT) in Argentina has granted approval for oral, once-daily ORLADEYO® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in adults and pediatric patients 12 years of age or older.

Generation Bio Co. (Nasdaq:GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, announced a strategic reorganization to prioritize investment in the development of its cell-targeted lipid nanoparticle (ctLNP) delivery system for wholly-owned programs in extrahepatic cell types.

BioCardia, Inc. [Nasdaq: BCDA] today provided an update after its recent consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure of reduced ejection fraction (HFrEF).