BioSpace News Archive

Baebies® announced it has received CE Mark for its FINDER® SARS-CoV-2 point-of-care test, which performs RT-PCR testing to detect SARS-CoV-2 on the FINDER 1.5 Instrument.

Azafaros B.V. announced that the US Food and Drug Administration has granted Orphan Drug Designation for AZ-3102, a novel small molecule with a unique dual mode of action, in Niemann-Pick disease type C. The designation was based on promising preclinical data of AZ-3120 in a NP-C mouse model, recently presented at the 18th Annual WORLDSymposium™.

Celsius Therapeutics provided a summary of recent corporate highlights, including the nomination of its first clinical candidate for inflammatory bowel disease, an additional $83 million in financing and key initiatives for 2022.

The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age.

Immuneering Corporation, a biopharmaceutical company using translational bioinformatics to advance a pipeline of product candidates designed to benefit large populations of patients with cancer and other diseases, announced that management will present at the 21st Annual Needham Virtual Healthcare Conference to share commentary around the Company’s pipeline, platform, and business strategy.

Akouos, Inc., a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, announced that Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer will participate in two upcoming virtual investor conferences in March.

Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced that the company will host a conference call and live webcast on Wednesday, March 30, 2022, at 8:00 a.m. ET to review business updates and its fourth quarter and fiscal year 2021 financial results.

Freeline Therapeutics Holdings plc today announced an updated clinical development plan and timelines for FLT190 for people with Fabry disease.

- Record revenues in 2021 of $15.6 million versus $6.1 million in 2020 - Continued progress of strategic agreement with AbbVie to develop dermal and soft tissue filler products using CollPlant’s rhCollagen - Company to advance 3D bioprinted regenerative breast implant program with launch of large animal study expected in Q2 - Strong balance sheet with $43.3 million cash position, as of December 31, 2021 [24

Bausch Health Companies Inc. today announced that Advances in Therapy has published new health economic and outcome research revealing that patients who received prescription medications approved by the U.S. Food and Drug Administration (FDA) for opioid-induced constipation (OIC-Rx) in the emergency department (ED) were less likely to be hospitalized, and when hospitalized, had a shorter length of stay than patients who did not receive an OIC-Rx in the ED.