BioSpace News Archive

AbbVie (NYSE: ABBV) today announced that it has submitted a supplemental New Drug Application (sNDA) for linaclotide (LINZESS®) to the U.S. Food and Drug Administration (FDA) for the treatment of children and adolescents 6 to 17 years of age with functional constipation (FC).

Moderna, Inc.(Nasdaq:MRNA) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a variation to the marketing authorization (MA) to include a booster dose of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), at the dose level for children (6-11 years) of 12.5mcg/12.5mcg (0.25 mL) at least three months after the last prior dose of a COVID-19 vaccine.

Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, announced today the approval by the EU-intergovernmental organization EUREKA secretariat of funding for the BRAVE Project (Breaking immune Resistance of Advanced cancers by HERV-K Vaccination and Epigenetic modulation) under the Eurostars-3 program.

Oncocyte Corporation, a precision diagnostics company, announced a reduction in force involving over 40% of Oncocyte’s workforce to realign its team towards key products that address larger markets.

Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, is providing an update on its U.S. Phase 2 study evaluating LB1148 for reduction in intra-abdominal adhesions in subjects following elective bowel resection (PROFILE).

Curate Biosciences, a key enabling technology company for cell therapy manufacturing, today announced that David M. Backer will become the Company’s next chief executive officer (CEO) and a member of Curate’s Board of Directors.

Aptorum Group Limited announced the completion of a private offering of USD$3 million aggregate principal convertible note due in December 2023, to be used towards the Company’s daily operations and clinical program.

Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that Biocon Limited, in collaboration with Equillium, has initiated a Phase 2 clinical study of itolizumab in patients with ulcerative colitis (UC).

Click Therapeutics, Inc. (“Click”), a leader in Digital Therapeutics™ as prescription medical treatments, today announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for CT-132.

Amicus Therapeutics (Nasdaq: FOLD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization of cipaglucosidase alfa, a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).