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Alligator Bioscience has announced positive second interim results from the ongoing OPTIMIZE-1 Phase 2 study of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer. The open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb agonist) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal […]

Emerging bispecific antibodies and their targets in cancer immunotherapy in the discovery, development, preclinical, and clinical stages. Monoclonal antibodies have revolutionized cancer therapy since their introduction as therapeutics in the field. To enhance the specificity and potency of antibodies, bispecific antibodies (bsAbs) are emerging, with the ability to bind two different antigens or two different […]

The company has announced that the Decentralized Procedure has ended with a positive outcome and that MOB-015 is recommended for national approval in 13 European countries for the treatment of mild to moderate fungal infections of the nails in adults. The Decentralized Procedure includes the following EU countries: Austria, Belgium, Czech Republic, Denmark, Finland, France, […]

Umeå Biotech Incubator (UBI) has been granted financing for the ERDF project “Life science city”, which will further develop the life science industry in the region 2024-2026. ”It feels gratifying that we get to build on our long-term goal,” says UBI’s Operations coordinator, Peter Jacobsson. ”Developments in recent years have shown the potential in Life […]

Bavarian Nordic has reported results from a Phase 3 non-inferiority clinical trial of ABNCoV2, a VLP-based, non-adjuvanted COVID-19 booster vaccine candidate. The two-part study enrolled a total of 4,205 adults who either previously completed primary vaccination or had already received one booster dose of a licensed COVID-19 vaccine. The active, controlled part enrolled 622 participants […]

The two companies have announced topline results from the follicular lymphoma (FL) cohort of the EPCORE NHL-1 clinical trial evaluating epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously. The study cohort includes 128 adult patients with relapsed/refractory follicular lymphoma (FL) who received at least two prior lines of systemic therapy. 70.3 percent of patients […]

Xigduo XR, a once-daily fixed-dose combination, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of adults with type-2 diabetes (T2D) as an adjunct to diet and exercise to improve glycaemic control. “People living with type-2 diabetes often have comorbidities such as heart failure and chronic kidney disease, leading to cardiorenal […]

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 therefore be initiated with a Biosimilar User Fee Amendment (BsUFA) goal date of April 21st, 2024, states the company. “Today’s sBLA acceptance marks an important […]

Novo Nordisk has announced data from the ONWARDS 1 and 3 trials evaluating investigative once-weekly basal insulin icodec. The data showed the studies met their primary endpoints, while reducing injections from seven to one per week, compared with once-daily basal insulin. Additionally, data from the ONWARDS 1 and 3 studies demonstrated that more insulin-naïve adults […]

Soliris has been recommended for marketing authorisation in the European Union (EU) for expanded use to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive (Ab+). If authorised, Soliris would be the first and only targeted therapy approved for the […]