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Lundbeck has announced that in support of Lundbeck’s Focused Innovator strategy with the aim to create financial flexibility and reallocate resources to other growth opportunities, it has been agreed with Takeda to modify the current collaboration in the U.S. from a co-promotion, cost-sharing, revenue-sharing, and royalty setup to a royalty-based only model effective 1 January […]

A commercially available blood test has now been trialled in routine healthcare. “The blood test showed about 90% reliability even in primary care. This may have major implications for all those individuals who seek help for memory loss and suspected Alzheimer’s,” say the researchers at Lund University in Sweden behind the study. The current study, […]

A new study from deCODE genetics and collaborators is the first to uncover a strong recessive component in Alzheimer’s disease. deCODE genetics/Amgen, and collaborators from Iceland, USA, UK, Denmark, Norway, and Sweden recently published the study: “Homozygosity for a missense variant in R47H in TREM2 and the Risk of Alzheimer’s Disease”, in New England Journal […]

Calliditas Therapeutics has announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN). The granting of the full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g […]

TikoMed has announced the publication in PLOS ONE of peer-reviewed research providing additional support that their low molecular weight dextran sulfate compound ILB is safe and well tolerated in patients with ALS. Eleven patients participated in the prospective, single-arm, open-label, phase II clinical trial encompassing long-term weekly ILB injections for up to 48 weeks of […]

Kristina Torfgård has experience in executive management, drug development, regulatory affairs and licensing with major international pharmaceutical companies, including in the field of neurodegenerative diseases. During her time at AstraZeneca, she held senior positions in both early and late-stage R&D and was globally responsible for marketed products. At the biopharmaceutical company Albireo/Pharma, she worked as […]

The topline data readout from the Phase II FOCUS trial demonstrated that adding UV1 to the standard of care pembrolizumab did not lead to clinical benefits in progression free survival or overall survival in those late-stage HNSCC patients, therefore, the study did not meet its primary and secondary endpoints. “We have implemented a broad Phase […]

Diamyd Medical has announced a successful interim analysis (non-futility test) for its ongoing precision medicine Phase 3 DIAGNODE-3 trial. The interim analysis, reviewed by an independent Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the trial without any modifications. “We are extremely pleased with the DSMB’s recommendation to continue the DIAGNODE-3 […]

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has communicated that it has adopted a negative opinion on BioArctic AB’s partner Eisai’s Marketing Authorization Approval (MAA) for lecanemab as treatment for Alzheimer’s disease. Lecanemab is already approved in the United States, Japan, China, South Korea, Hong Kong, and […]

Xbrane Biopharma will regain full rights to BIIB801 following a decision by Biogen to terminate the commercialization and license agreement between the companies. All rights to the product will be reverted to Xbrane. An out-licensing process to identify a new partner has been initiated. BIIB801 is a preclinical monoclonal antibody fragment that is a proposed […]