Biotech Business - October 21, 2024
Eisai will request reconsideration of initial decision for lecanemab in Australia
BioArctic's partner Eisai has announced that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD dementia.
New Market - September 24, 2024
AstraZeneca’s FluMist approved for self-administration in the US
FluMist, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.
Business article - September 19, 2024
Thermo Fisher Scientific will open bioanalytical laboratory in Gothenburg
A new bioanalytical laboratory, creating up to 140 new jobs for researchers and laboratory staff, will be established during the last quarter of 2025.
Biotech Business - September 17, 2024
Oncopeptides signs license agreement with SCBIO
Oncopeptides has announced that it has signed an exclusive license and supply agreement with SCBIO, a Korean pharmaceutical company for the commercialization of Oncopeptides’ flagship drug Pepaxti in South Korea.
New Market - August 19, 2024
AstraZeneca’s Imfinzi approved in the US
Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. In this regimen, patients are treated with Imfinzi in combination with neoadjuvant chemotherapy […]
New Market - August 7, 2024
The European Commission has granted a full marketing authorization for Kinpeygo
Calliditas Therapeutics has announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). The granting of the full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g […]