BioSpace News Archive

The FDA provided briefing documents ahead of Amylyx’s rare second adcomm for AMX0035, an investigational treatment for ALS. The regulator does not appear to be convinced.

Industry observers say the Inflation Reduction Act of 2022 could affect the direction of research, and some fear it may lead to further government forays into price control.

Vernalis Research, a fully owned subsidiary of HitGen Inc., and Unison Medicines Inc. are pleased to announce a research collaboration on an undisclosed bacterial target.

Alvotech announced that Alvotech received communication from the U.S. Food and Drug Administration detailing its assessment of the March 2022 inspection of Alvotech’s manufacturing facility in Reykjavik, Iceland and Alvotech’s subsequent written responses to the FDA.

Spectrum Pharmaceuticals, a biopharmaceutical company focused on novel and targeted oncology therapies, announced a poster presentation titled: High Activity of Poziotinib in G778_P780dup HER2 Exon 20 Insertion Mutations in Non-Small Lung Cancer.

Regeneron Pharmaceuticals, Inc. and Sanofi announced results from a Phase 3 open-label extension trial demonstrating the efficacy and safety profile of Dupixent® as a maintenance therapy when added to other asthma medications was consistent for up to two years in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma with evidence of type 2 inflammation.

Tyra Biosciences, Inc. announced that the Company will be presenting preclinical data on TYRA-300 during a poster session at the European Society for Medical Oncology 2022 Congress, being held in person September 9-13, 2022 in Paris, France.

Bertis announced on the 5th that the research results of their search for protein biomarkers for early diagnosis of high-grade serous ovarian cancer were published in the September issue of the international scientific journal, Journal of Proteome Research.1 This press release features multimedia.

Onera Health, a leader in transforming sleep medicine and remote monitoring, announced the official launch of its ground-breaking solution to diagnose sleep disorders in Europe.

Lytix Biopharma, a Norwegian immune-oncology company, announces the appointment of Stephen Worsley as Chief Business Officer.