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Intellectual Property - August 30, 2022
NextCell Pharma has announced that the Japan Patent Office (JPO) has issued a notice of allowance relating to the patent entitled “Allogeneic Composition”. The patent describes the method of manufacturing the drug candidate ProTrans, where the selection algorithm is key for selecting optimal cells and donors. “Japan is leading the cell therapy and stem cells […]
Collaboration - August 30, 2022
Zerion Pharma and the Spanish pharmaceutical group Insud Pharma will develop and commercialize drug products applying ZERION’s Dispersome technology. Zerion will develop Dispersome formulations of marketed drug products while Insud will be responsible for the finished product dosage form, the clinical development as well as global marketing and sales of the final products. A worldwide […]
Clinical Trials - August 29, 2022
New results from a pre-specified, patient level, pooled analysis from the Phase III DAPA-HF and DELIVER trials demonstrated mortality benefit of Farxiga, compared to placebo, in patients with heart failure (HF). The reduction in risk of cardiovascular (CV) death was consistent across pre-specified subgroups and is the first analysis to demonstrate a mortality benefit with […]
Biotech Business - August 29, 2022
The company has announced that further to the decisions to discontinue the PARADIGME study, restructure the company and appoint Carnegie Investment Bank to explore strategic options, the senior leadership team will be consolidated, and the current CEO Erik Skullerud will transition out of his role. Nordic Nanovector’s Chief Financial Officer Malene Brondberg will assume the […]
Biotech Business - August 29, 2022
Calliditas Therapeutics announced in July that the European Commission (EC) has granted conditional marketing authorization for Kinpeygo for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram. Kinpeygo is an orphan medicinal product and the first and only approved […]
Biotech Business - August 26, 2022
The company has entered into a binding agreement for a financing commitment with Negma Group (of up to 200 MSEK) as well as a binding commitment letter to receive a shareholder loan (up to 50 MSEK) with its existing shareholder Van Herk Investments. The financing commitments will allow the company to reach its next clinical […]
In a new job - August 26, 2022
InDex Pharmaceuticals Holding announced in April 2022 that after more than seven years as CEO, Peter Zerhouni has decided to leave his position. The company’s CFO Johan Giléus has been appointed acting CEO while a new CEO is being recruited, and he will also continue as CFO. “With the drug candidate cobitolimod in phase III, […]
Clinical Trials - August 26, 2022
The Clinical Trial Application (CTA) to initiate the company’s Phase 2b study, with its candidate drug, AP1189, in patients with newly diagnosed rheumatoid arthritis (RA) has been approved in Moldova. The aim is to start recruitment of patients as soon as the study sites has been initiated in September, states the company. “This is a […]
Clinical Trials - August 24, 2022
During the summer, the application to start clinical studies of PN6047 was approved by the Swedish Medical Products Agency and Ethical Review Authority, and the first dose has now been given to humans. The primary goal of phase I studies is to investigate the safety and tolerability of the candidate PN6047. The trials are being […]
COVID-19 - August 24, 2022
Researchers at Karolinska Institutet are developing a coronavirus vaccine designed to be less sensitive to mutations and equipped for future strains. The vaccine showed promising results in mice in a newly published study in EMBO Molecular Medicine, and the researchers now hope to be able to take it to safety studies on humans. “This is […]
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