BioSpace News Archive

Jiangsu Recbio Technology Co., Ltd. is pleased to announce that, the Group has recently received the clinical trial approval for its novel adjuvanted recombinant shingles vaccine, REC610, from the Food and Drug Administration of the Philippines.

F2G Inc. announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options.

Forward Pharma A/S, announced that that on December 16, 2022 it received written notice from The Nasdaq Stock Market LLC notifying us that Nasdaq believes that Forward is a “public shell” pursuant to Listing Rule 5101, and that the continued listing of its securities is no longer warranted.

GenFleet Therapeutics today announced that it has entered into a clinical trial collaboration and supply agreement with Merck to start a clinical study of the combination therapy of GFH925 with ERBITUX® (cetuximab) as a potential frontline treatment among NSCLC patients harboring KRAS G12C mutation in a multi-center Phase Ib/II trial in Europe.

BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV) today announced that the United States Patent and Trademark Office (USPTO) has issued a notice of allowance, informing the company that a patent application covering i.a. the anti-FcγRllB antibodies BI-1206 and BI-1607 will be granted contingent on payment of the issue fee.

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) announced today that the U.S. Food and Drug Administration (“FDA”) has approved an additional indication for PEMFEXY® (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (“NSCLC”) with no EGFR or ALK genomic tumor aberrations.

ObsEva SA, a biopharmaceutical company developing and commercializing novel therapies for women’s health, announced that the competent court in Geneva, Switzerland has granted the Company’s request to withdraw its moratorium considering that the Company is no longer over-indebted.

Attralus, Inc., a clinical stage biopharmaceutical company developing transformative medicines to improve the lives of patients with systemic amyloidosis, announced today that the European Commission (EC) and European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan designation for AT-01 (iodine (I-124) evuzamitide) as a diagnostic for the management of both immunoglobulin light chain amyloidosis (AL) and transthyretin (ATTR) amyloidosis.

Axogen, Inc. announced that Bri Majsiak, a Resensation® patient, has been selected to ride on the 2023 Donate Life Rose Parade Float and Madelyn Nicpon will be honored at this year’s event through a floragraph that will adorn the float.

XORTX Therapeutics Inc. is pleased to announce the completion of dosing in the XRX-OXY-101 pharmacokinetics bridging study (the “Study”).