BioSpace News Archive

MANA Therapeutics, a clinical-stage company creating nonengineered, off-the-shelf allogeneic cell therapies that target multiple cancer antigens, announced the final closing of its Series A financing, bringing the total raised to $42 million.

AcuPebble SA100, a small wearable device that enables automated, remote home testing to detect obstructive sleep apnea (OSA) in adults, has obtained FDA 510(k) clearance as a Class II medical device in the USA.

LYNPARZA ® (olaparib) Granted Priority Review in the US for BRCA-Mutated HER2-Negative High-Risk Early Breast Cancer.

Pardes Biosciences, Inc., a clinical-stage biopharmaceutical company developing PBI-0451 as a potential direct-acting, oral antiviral drug to treat and prevent SARS-CoV-2 infections, today announced that Philippe Tinmouth has been appointed as Chief Business and Strategy Officer.

Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPD) a clinical stage pharmaceutical development company is pleased to announce that it has appointed Mr. James Kinley as the Company’s Chief Financial Officer (“CFO”), effective December 1, 2021.

Allakos Inc. (the “Company” or “Allakos”) (Nasdaq: ALLK), a biotechnology company developing lirentelimab (AK002) for the treatment of eosinophil and mast cell-related diseases, today announced it has initiated a randomized, double-blind, placebo-controlled Phase 2 clinical trial of subcutaneous (SC) lirentelimab in adult patients with moderate-to-severe atopic dermatitis.

First Wave BioPharma, Inc.,, a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal diseases, announced that an independent data monitoring committee has recommended that enrollment continue in Part 2 of the ongoing RESERVOIR Phase 2 trial evaluating FW-COV as a treatment for COVID-19-related gastrointestinal infections.

ImmunoGen Inc. today announced positive top-line data from the pivotal SORAYA trial evaluating the safety and efficacy of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin® (bevacizumab).

FDA Accepts Regulatory Submission of Supplemental New Drug Application for LYNPARZA ® (olaparib) as Adjuvant Treatment in BRCA -Mutated, HER2-Negative High-Risk Early Breast Cancer and Grants Priority Review.

BD (Becton, Dickinson and Company) today issued the following statement regarding testing for the COVID-19 Omicron variant of concern.