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Controlant’s real-time supply chain monitoring and visibility technologies are specifically geared to the pharmaceutical and life sciences sectors and emerged as a key cold chain solution for the COVID-19 vaccines during the pandemic. The COVID-19 pandemic has really shed light on the importance of a robust, efficient, quick, sustainable and cost-effective pharma supply chain. In […]

Shanghai Henlius Biotech has received IND approval from China’s National Medical Products Administration for a Phase 2 clinical trial of AC101 in combination with anti-PD-1 monoclonal antibody HANSIZHUANG, HANQUYOU and chemotherapy as a 1st line treatment for HER2-positive locally advanced/metastatic gastric cancer patients. Alligator out-licensed AC101 (HLX22) to the South Korean company AbClon, Inc. in […]

Affibody’s licensee Rallybio Corporation has announced positive topline results from a Phase 1 single ascending dose (SAD) study in healthy participants of RLYB116. In the ongoing Phase 1 study, all study participants that were administered a single 1 mL subcutaneous injection of 100 mg of RLYB116 (n=6) demonstrated a reduction in free C5 greater than […]

This year’s Nobel discoveries in Medicine have provided us with answers about ourselves, for example our immune system and how to decipher genetic risks, but also about our origin and context. On October 3rd 2022, the Nobel Prize in Physiology or Medicine was awarded to Swedish geneticist Svante Pääbo, a professor at the Max Planck […]

Cantargia has reported new data providing further insights to the mechanisms underlying the antitumor activity of the IL1RAP-binding antibody nadunolimab (CAN04). In a model of the pancreatic cancer (PDAC) microenvironment, nadunolimab potently reduced levels of various tumor-promoting molecules, in sharp contrast to an anti-IL-1β antibody which showed no such effects, reports the company in a […]

AI Medical Technology announces its quality management system is now ISO 13485:2016 certified by BSI under the certificate number MD762240. This indicates that AI Medical Technology’s quality management system conforms to the recognized international standard for the design, manufacture and distribution of medical devices. The certification also demonstrates that AI Medical Technologies’ quality management system […]

AstraZeneca and Sanofi’s Beyfortus has been approved in the European Union (EU) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season. Beyfortus is the first and only single-dose RSV passive immunisation for the broad infant population, including those born healthy, at term or […]

AstraZeneca’s COVID-19 vaccine, Vaxzevria, has been granted full Marketing Authorisation (MA) in the European Union (EU). Vaxzevria was originally granted a conditional Marketing Authorisation (cMA) due to the urgency of the COVID-19 pandemic. As there continues to be sufficient evidence of safety and efficacy confirming the benefits of Vaxzevria, the European Medicines Agency (EMA) has now granted a full […]

This year the Swedish-Danish life science cluster organisation, Medicon Valley Alliance, is celebrating it’s 25th anniversary. Our organization, which has Lund University and University of Copenhagen as its founding fathers, and the bi-national region we embrace, has come a long way since the humble beginnings in the late 1990s when the Øresund Bridge was still […]

SynAct Pharma has announced that it has received clearance from the US Food and Drug Administration (FDA) of its Investigational New Drug (IND) application for a Phase 2a/b study in Rheumatoid Arthritis (RA) with the company’s lead compound AP1189. The IND was submitted to the FDA Division of Rheumatology and Transplant Medicine (DRTM) on September […]