Production & SalesMarketing & Sales October 9, 2020 Janssen Pharmaceutical to supply up to 400 million Covid-19 vaccine doses to EU By PBR Staff Writer The deal also includes an option that allows supply of up to 200 million additional doses to the EU member states. This agreement was signed after the conclusion
RegulationDrug Filing October 8, 2020 ARCA gets FDA approval of IND for Covid-19 drug candidate AB201 By PBR Staff Writer With the IND approval in place, the company expects to launch a phase 2b/3 sequential clinical trial of AB201 in the fourth quarter of 2020. The phase 2b
Clinical TrialsHuman Trials October 7, 2020 GSK, Vir Biotechnology to expand Covid-19 treatment study By PBR Staff Writer The companies announced the global expansion to phase 3 of the Covid-19 monoclonal antibody efficacy trial – intent to care early (COMET-ICE) to assess VIR-7831 for the early
Drug DiscoveryResearch & Development October 6, 2020 Bristol Myers Squibb to buy biopharmaceutical firm MyoKardia for $13.1bn By PBR Staff Writer MyoKardia is engaged in the discovery and development of targeted therapies to treat serious cardiovascular diseases. As per terms of the merger deal, BMS subsidiary will begin a
RegulationDrug Filing October 5, 2020 AstraZeneca’s Farxiga gets FDA breakthrough status in CKD By PBR Staff Writer Farxiga is an oral, once-daily sodium-glucose co-transporter-2 inhibitor (SGLT2 inhibitor). Its breakthrough therapy designation in chronic kidney disease was driven by the findings of phase 3 DAPA-CKD trial.
Drug DiscoveryResearch & Development October 1, 2020 Pfizer to acquire minority stake in CStone Pharmaceuticals for $200m By PBR Staff Writer Under the deal, CStone and Pfizer will involve in the development and commercialisation of CStone’s sugemalimab, an investigational anti-PD-L1 monoclonal antibody, in mainland China. They will also co-develop
Clinical TrialsHuman Trials September 30, 2020 MedinCell begins first Covid-19 clinical study with Ivermectin By PBR Staff Writer The randomised, double-blind, exploratory phase I trial A has been designed to evaluate the pharmacokinetic profile, safety and tolerability of a continuous daily dosing regimen of Ivermectin in
RegulationApprovals September 29, 2020 Pfizer gets FDA nod for Xeljanz to treat juvenile idiopathic arthritis By PBR Staff Writer Xeljanz, claimed to be the first and only Janus kinase (JAK) inhibitor approved in the US to treat pcJIA, is available in two formulations such as a tablet
RegulationApprovals September 28, 2020 GSK gets FDA approval for Nucala to treat hypereosinophilic syndrome By PBR Staff Writer Nucala has been approved to treat adult and paediatric patients aged 12 years and older with HES ≥ six months without an identifiable non-haematologic secondary cause. Mepolizumab, the
Clinical TrialsHuman Trials September 23, 2020 Sinovac begins Covid-19 vaccine candidate trials in Turkey By PBR Staff Writer The phase III clinical trials will assess the efficacy and safety of the CoronaVac vaccine candidate, which is developed by Sinovac Life Sciences. Sinovac’s case-driven, randomised, double-blinded and