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The European Commission (EC) has granted Novavax conditional marketing authorization (CMA) for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The authorization follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine […]

The Committee for Medicinal Products for Human Use of the EMA has adopted a positive opinion of Kineret for the treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor ≥ 6ng/ml. EMA has […]

AstraZeneca’s new facility for the production of next generation biologics will create almost 900 new jobs. Sweden Biomanufacturing Center (SBC) is located in Södertälje. “It is no coincidence that we have chosen to launch this production site in Sweden. Sweden is in many ways attractive and we will continue to invest here, given Sweden’s strong […]

AstraZeneca and Amgen’s Tezspire has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma. Tezspire was approved following a Priority Reviewby the US Food and Drug Administration (FDA) and based on results from the PATHFINDER clinical trial programme. The application included […]

Elicera Therapeutics has signed an agreement with Baylor College of Medicine (BCM), Center for Cell & Gene Therapy regulating contract manufacturing of ELC-201, the company’s oncolytic virus armed with Elicera’s fully developed iTANK-platform for a multi-targeted attack on cancer. This is the second collaboration between Elicera and Baylor College of Medicine (BCM), Center for Cell […]

Novo Nordisk has announced that a contract manufacturer filling syringes for Wegovy pens for the US market has temporarily stopped deliveries and manufacturing following issues with Good Manufacturing Practices. As a consequence, Novo Nordisk does not expect to be able to meet demand in the US in the first half of 2022 and few new […]

An adventurous spirit rooted in a Viking heritage and her parents’ as an example helped spur Gitte Pedersen to move from her native Denmark to the U.S. 20 years ago, where she helped create a company and made a home. CEO and co-founder of Genomic Expression in Massachusetts, USA, Gitte Pedersen also credits her mother […]

Foundations behind Medicon Village has decided to award almost 25 million SEK to nine research projects in Malmö and Lund. Mats Paulsson’s foundation for research, innovation and community building has decided to award 13,600,000 SEK for purposes that promote research within medicine and life sciences. The goal is to benefit healthcare, development, innovation and community […]

Calliditas Therapeutics has announced that the US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5g/g. This indication is approved under accelerated approval. It has not been established […]

Affibody, ACELYRIN, and Inmagene Biopharmaceuticals, have announced that a 16-week, global, Phase 2 clinical trial of izokibep in patients with psoriatic arthritis (PsA) met its primary endpoint in a pre-specified interim analysis. The double-blind, placebo-controlled Phase 2 clinical trial, designed and conducted by Affibody, evaluated the safety and efficacy of izokibep dosed 80 mg every […]