BioSpace News Archive

The FDA has a number of PDUFA dates for the remainder of November for Spectrum, ImmunoGen, Scynexis and Y-mAbs.

Teva Pharmaceuticals has found its new president and CEO. Effective Jan. 1, 2023, Richard Francis will take the company’s reins as Kåre Schultz retires.

With a $1.36 billion buyout, Merck bolstered its oncology program with the acquisition of Biotech Bay-based Imago Biosciences, a company focused on chronic bone marrow cancers.

Lysogene’s investigational gene therapy LYS-SAF302 failed to meet its primary and key secondary efficacy endpoints in mucopolysaccharidosis type IIIA.

In a volatile year, marked with challenges, BioSpace is taking a pause to reflect on the many “wins” in biopharma.

OKYO Pharma Limited announced that it filed an Investigational New Drug application with the U.S. Food and Drug Administration for the development of OK-101 to treat dry eye disease.

Diadem SpA, a company developing the first blood-based test for the early prediction of progression to Alzheimer’s disease, announced key additions to its senior management team.

The board of directors of the Company is pleased to announce that in order to meet the rapidly growing market demand for HPV 9-valent vaccines in China and the international market, after process optimization, facility upgrading and verification, the peak production capacity for the first phase of the HPV vaccine manufacturing facility of the Company will be increased to an annual output of 20 million doses of recombinant HPV 9-valent vaccine.

BioArctic AB’s partner Eisai will present the efficacy, safety and biomarker results from the Phase 3 confirmatory Clarity AD clinical trial for lecanemab, at the 15th Clinical Trials on Alzheimer’s Disease conference, held in San Francisco, CA and virtually from November 29 to December 2.

Medivir AB, a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced that Pia Baumann has been recruited as its new Chief Medical Officer.