The company has announced the acceptance of the supplemental Biologics License Application (sBLA) for a Lucentis (ranibizumab) biosimilar candidate by the US Food and Drug Administration. The regulatory process can

The FDA Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from the Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI

The company will invest 15.9 billion DKK starting in 2023 to expand an existing Active Pharmaceutical Ingredient (API) production facility in Denmark for the future portfolio within serious chronic diseases.

Mendus has entered into a manufacturing alliance with NorthX Biologics and has announced a directed share issue and a fully secured rights issue of units totaling approximately 317 million SEK

Oncopeptides has been informed that the preliminary investigation by the Swedish Economic Crime Authority of the company’s Chief Scientific Officer and former CEO, Jakob Lindberg, has been terminated. In their

The Iceland-founded biopharmaceutical company was officially listed on the Nasdaq stock exchange in New York, making it the first Icelandic VC portfolio company to go public. Both Klappir and Solid

The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD) to the company’s lead asset mitazalimab for the treatment of pancreatic cancer. “This designation is a key milestone

On behalf of the Swedish government, the Swedish innovation agency Vinnova has decided on funding of an innovation cluster for commercialization, competence development and production capacity for advanced therapies. The

The money has been raised for additional development activities of their product pHyph for antibiotic free treatment of vaginal infections. The funds will be used for an ongoing proof-of-concept study

BioLamina announces the release of the first Biolaminin 521 LN batches issued from its new manufacturing facility in Sundbyberg, Sweden. The products, which are now ready for commercialization, have been

Swedish Orphan Biovitrum (Sobi) has entered into an agreement and plan of merger with CTI BioPharma (CTI) under which Sobi has agreed to acquire CTI, by means of a tender

Koselugo (selumetinib) has been approved in China for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above. “Koselugo

The company’s autologous natural killer (NK) cell therapy candidate XNK04 will be evaluated in combination with an ADCC competent PD-L1 inhibitor in liver cancer under a research agreement with a

The two companies are now supplying Ximluci (ranibizumab biosimilar) in England via a National Health Service (NHS) England Framework Agreement. The partners announced in January 2023 that the UK’s Medicines

Ranibizumab biosimilar is being launched in major European markets. Ranibizumab is the first product brought to market through a strategic collaboration between STADA and Xbrane Biopharma, marking Xbrane’s first commercial