The U.K. has become the first country in Europe to approve Leqembi (lecanemab), but as the breakthrough decision was announced, the health technology assessment body NICE said the benefits are too small to justify the cost of providing the Alzheimer’s disease therapy on the National Health Service (NHS).
European biopharmas saw a huge surge in new funding in the second quarter of 2024, raising a collective $4.1 billion, compared to $1.9 billion in the same period of 2023. With the IPO market in Europe still virtually non-existent, $1.45 billion of this was venture capital, while $2.64 billion was raised in follow-on funding. The majority of VC funding was raised by companies in five countries, with $799.6 million raised in the U.K., $272.5 million in Switzerland, $201.8 million raised in Germany, $59 million in France and $25.7 million in Sweden.
Novo Nordisk A/S presented a mixed bag of R&D results for its cardiometabolic assets in the first half of 2024 as it axed three drug candidates but advanced one to a late-stage study. In the search for greener pastures beyond a crowding obesity market, Novo announced Aug. 7 that it advanced ziltivekimab into a phase III study to assess the subcutaneous therapy’s cardiovascular outcomes in acute myocardial infarction patients.
Levicept Ltd. is scoping the options for phase III development after reporting positive results from its phase II trial of LEVI-04 in the treatment of pain caused by osteoarthritis of the knee. The full data are yet to be published, but the company said the potentially first-in-class neurotrophin-3 inhibitor demonstrated significant differences from placebo, with a mean reduction in pain score from baseline of more than 50%, for the three doses tested.
Immunotherapy-focused biotech company LTZ Therapetics Inc. raised $20 million in a series A round that will advance development of its myeloid engager pipeline to treat cancer and autoimmune diseases. Proceeds from the funds will accelerate development of lead asset LTZ-301, which is expected to enter the clinic in early 2025, LTZ founder and CEO Robert Li told BioWorld.
For the first time in six years, the U.K.’s National Institute for Health and Care Excellence (NICE) is refusing to recommend a breast cancer treatment. It cited price as the issue.
With the COVID-19 pandemic still visible in the rearview mirror, the World Health Organization (WHO) is taking no chances as it preps for human avian influenza, or H5N1, a subtype of influenza A.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of 14 drugs and the extension of the label of 11 others at its July meeting, but, inevitably, it was the decision to turn down the Alzheimer’s disease therapy Leqembi (lecanemab) that stirred the greatest reaction.
The European Commission has approved Cstone Pharmaceuticals Ltd.’s PD-L1 monoclonal antibody, sugemalimab, in combination with platinum-based chemotherapy for first-line treatment of adults with metastatic non-small-cell lung cancer with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations.
Astellas Pharma Inc.’s claudin (CLDN) 18.2-targeted monoclonal antibody, zolbetuximab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and could be the first CLDN18.2 molecule to be approved in Europe if it receives final approval.
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