RegulationApprovals December 21, 2021 FDA approves ViiV Healthcare’s Apretude for HIV prevention By PBR Staff Writer The long-acting injectable is indicated for use in adults and adolescents who are at risk of sexually acquiring HIV and test negative for HIV-1 before initiation. The regulatory
Immunology December 16, 2021 Boehringer Ingelheim announces FDA acceptance of BLA for spesolimab By PBR Staff Writer Boehringer Ingelheim has announced acceptance of a biologics license application (BLA) and granting of priority review by the US Food and Drug Administration (FDA) for spesolimab in treating
Drug Manufacturing December 14, 2021 Novo Nordisk to invest in new production facilities at Danish plant By PBR Staff Writer Novo Nordisk has announced plans to make more than $2.58bn (DKK17bn) investment to expand its manufacturing facilities in Kalundborg, Denmark. The company plans to construct three new manufacturing
RegulationApprovals December 13, 2021 Pfizer’s Cibinqo receives EC approval for atopic dermatitis treatment By PBR Staff Writer The European Commission (EC) has approved Pfizer’s Cibinqo (abrocitinib) to treat moderate-to-severe atopic dermatitis (AD) adult patients. The 100mg and 200mg doses of the oral small molecule drug
Drug DiscoveryResearch & Development December 8, 2021 Arbutus discovers molecular targets to treat Covid-19 By PBR Staff Writer Canadian biopharmaceutical firm Arbutus Biopharma has identified many molecules that can inhibit the SARS-CoV-2 nsp5 main protease (Mpro), achieving its first milestone under Covid-19 discovery research and license
RegulationApprovals December 6, 2021 Merck’s Keytruda obtains FDA approval as adjuvant therapy for melanoma patients By PBR Staff Writer Merck’s anti-PD-1 therapy, Keytruda, has obtained approval from the US Food and Drug Administration (FDA) as an adjuvant therapy for stage IIB or IIC melanoma patients aged 12
Infectious Disease December 3, 2021 EMA begins rolling review of Valneva’s Covid-19 vaccine candidate VLA2001 By PBR Staff Writer Valneva stated that it is now focused on securing regulatory approvals for VLA2001 after the positive results from the Phase III trial. The firm also added that it
Research and Development (RD) November 30, 2021 Gilead Sciences selects AWS as preferred cloud provider By PBR Staff Writer The move will enable Gilead to leverage AWS machine learning technologies and analytics to accelerate data-driven decision making across the organisation. The technologies are expected to support clinical
Drug DiscoveryResearch & Development November 19, 2021 Novo Nordisk to buy Dicerna to expand RNAi technology use By PBR Staff Writer Danish pharma company Novo Nordisk has agreed to acquire Dicerna Pharmaceuticals and its ribonucleic acid interference (RNAi) platform in a deal valued at $3.3bn, to expand the RNAi
Biotechnology November 10, 2021 Arbor Biotechnologies raises $215m through Series B round By PBR Staff Writer With this round, the biotechnology firm has raised more than $300m so far. The funding round was led by Ally Bridge Group, TCG Crossover, and Temasek. Among the