The European Commission (EC) has granted unconditional approval for Hewlett Packard Enterprise Company (HPE) to acquire Juniper Networks, Inc., concluding that the deal raises no competition concerns within the European Economic Area (EEA). This clearance marks a significant step in HPE’s strategic expansion into the networking sector, following the announcement of the $14 billion transaction […]
In a significant development for the treatment of drug-resistant tuberculosis (TB), Johnson & Johnson has announced that SIRTURO (bedaquiline) has received full approval from the U.S. Food and Drug Administration (FDA) and the European Commission (EC). This approval marks a pivotal milestone in the fight against pulmonary TB that is resistant to standard treatments like […]
The European Commission (EC) has granted approval for a monumental €10.82 billion scheme to support France’s ambitious offshore wind energy projects, marking a significant stride towards achieving a net-zero economy. This decision aligns with the State aid Temporary Crisis and Transition Framework (TCTF), reflecting a committed effort to foster sustainable energy solutions. This funding initiative, […]
Voydeya (danicopan), a first-in-class oral Factor D inhibitor from Alexion, AstraZeneca Rare Disease, has received approval from the European Commission as an add-on treatment to standard-of-care therapies ravulizumab (Ultomiris) or eculizumab (Soliris) for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who suffer from residual haemolytic anaemia. This approval marks a significant advancement for the approximately […]
The European Commission, exercising its authority under the EU Merger Regulation (EUMR), has granted approval to Illumina’s proposed divestment of GRAIL. This decision, crucial for the restoration of competitive equilibrium in the blood-based early cancer detection market, follows the Commission’s previous order in October 2023 requiring Illumina to reverse its acquisition of GRAIL. The deal […]
Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT), a leading global clinical-stage messenger RNA medicines company, has achieved a significant milestone in the development of treatments for infectious diseases and rare liver and respiratory conditions. The European Commission (EC), influenced by a favorable review from the European Medicines Agency (EMA), has recently granted orphan medicinal product designation […]
Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a trailblazer in the oncology sector specializing in the development of next-generation radiopharmaceuticals, has announced a landmark exclusive worldwide license agreement with Heidelberg University and Euratom, represented by the European Commission, Joint Research Centre. This pivotal agreement confers upon Fusion the exclusive worldwide rights to develop, manufacture, and commercialize compounds […]
In a landmark decision, the European Commission (EC) has authorized Biogen Inc.’s SKYCLARYS (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. This approval heralds SKYCLARYS as the first medication sanctioned within the European Union for this rare, genetic, and progressively debilitating neurodegenerative disease, promising a new […]
In a landmark decision, the European Commission has approved GSK plc’s Omjjara (momelotinib), introducing a revolutionary treatment for adult myelofibrosis patients suffering from moderate to severe anaemia. This authorization positions Omjjara as the first medicine in the EU specifically targeting disease-related splenomegaly (enlarged spleen) or symptoms in this patient demographic, whether newly diagnosed or previously […]
A groundbreaking development in bladder cancer treatment is on the horizon as Astellas Pharma Inc. and Pfizer Inc. await the European Medicines Agency’s (EMA) review of their recent application. This significant step involves a Type II variation application for PADCEV (enfortumab vedotin) combined with KEYTRUDA (pembrolizumab), targeting first-line treatment of adult patients with previously untreated […]