ALX Oncology Holdings, an Australian immuno-oncology company focusing on CD47 checkpoint pathway blocking therapies, declared a significant milestone with its flagship drug candidate evorpacept securing the European Commission’s (EC) orphan drug designation (ODD). This key approval marks a turning point in the treatment for patients suffering from gastric cancer, including gastric cancer and gastroesophageal junction […]
Incyte has secured marketing authorization for Opzelura (ruxolitinib) cream 15mg/g from the European Commission (EC) for non-segmental vitiligo with facial involvement in adults and adolescents, aged 12 years and above. Opzelura is a cream formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib. It has been approved in the European Union (EU) to offer support for repigmentation […]
Akthelia Pharmaceuticals, a preclinical drug development startup, and the University of Iceland have jointly secured a €6 million EU Horizon Grant for the IN-ARMOR project. The joint IN-ARMOR project is anticipated to develop new innate immune system inducers to deal with antimicrobial resistance (AMR), a global health threat, and minimize infections, including two of the […]
Bristol Myers Squibb (BMY) has secured full marketing authorization for Reblozyl (luspatercept) from the European Commission (EC) for treating anemia associated with non-transfusion-dependent (NTD) beta thalassemia in adult patients. Presently, Reblozyl is approved in the European Union (EU), the US, and Canada for addressing anemia resulting from transfusion-dependent beta thalassemia and transfusion-dependent lower-risk myelodysplastic syndromes. […]
German-based biotechnology company CSL Behring has received conditional marketing authorization (CMA) from the European Commission (EC) for its Hemgenix (etranacogene dezaparvovec) indicated for the treatment of hemophilia B in adults. Hemgenix (also known as CSL222, previously known as AMT-061) is an adeno-associated virus five (AAV5)-based gene therapy intended to be given as a one-time treatment […]
French pharmaceutical company Sanofi and Regeneron, an American biotechnology company, have received the approval of the European Commission (EC) to market their Dupixent (dupilumab) injection in the European Union for eosinophilic esophagitis (EoE). Dupixent is indicated in adults and adolescents 12 years and over, who are not candidates for conventional medicinal treatment. With the approval, […]
Novartis has received the approval of the European Commission (EC) for Pluvicto (lutetium (177Lu) vipivotide tetraxetan), a targeted radioligand therapy for advanced prostate cancer. Following the approval, Pluvicto has become the first targeted radioligand therapy to be commercially available to prevent advanced prostate cancer in individuals. Pluvicto in combination with androgen deprivation therapy (ADT) with […]
Takeda has received the European Commission’s (EC) marketing authorization for the company’s dengue vaccine QDENGA (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The QDENGA vaccine is indicated for use in individuals aged four and above in the European Union (EU) to prevent any of the four dengue serotypes. The approval from the EC was backed by […]
The European Commission has launched a full-scale phase 2 investigation to evaluate the previously announced acquisition of Activision Blizzard by Microsoft under the European Union (EU) Merger Regulation. In January 2022, Microsoft signed an all-cash deal to acquire US-based video game publisher Activision Blizzard for $68.7 billion. Read more about Microsoft acquisition of Activision Blizzard […]
IGI Poseidon, through its subsidiary ICGB AD, has commenced commercial operation of the Greece-Bulgaria Interconnection gas pipeline (IGB) to diversify gas supply in the South-East European region. With a gas transportation capacity of three to five billion cubic meters, the Greece-Bulgaria Interconnection gas pipeline was developed by IGI Poseidon in partnership with Bulgarian Energy Holding. […]