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Home » Topics » Europe, BioWorld

Europe, BioWorld
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European investing illustration

Outlook ‘very promising’ for European firms on Q2 funding surge

Aug. 16, 2024
By Nuala Moran
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.
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Blue heart and data grid

Novo chops three drug studies at cardiometabolic intersection

Aug. 8, 2024
By Marian (YoonJee) Chu
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.
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Person holding knee, joint pain

Levicept cites ‘truly exceptional’ data in osteoarthritis trial

Aug. 6, 2024
By Nuala Moran
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.
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LTZ raises $20M to bring LTZ-301 to clinic for B-cell tumors

Aug. 1, 2024
By Tamra Sami
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.
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NICE says no to Enhertu, blames price

July 30, 2024
By Mari Serebrov

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.


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WHO preps for human avian flu spread with mRNA vaccine project

July 30, 2024
By Mari Serebrov
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.
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Leqembi

EMA’s CHMP issues thumbs-down on Alzheimer’s drug Leqembi

July 30, 2024
By Nuala Moran
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.
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Monoclonal antibody illustration

European Commission approves Cstone PD-L1 sugemalimab in NSCLC

July 30, 2024
By Tamra Sami
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.
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EU flags in front of the Berlaymont building

A CHMP thumbs up for Astellas’ Claudin18.2 zolbetuximab

July 29, 2024
By Tamra Sami
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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From Day One, Ipsen gains ex-US rights to tovorafenib for $461M

July 26, 2024
By Marian (YoonJee) Chu
Ipsen SA, of Paris, struck a $461 million deal with Day One Biopharmaceuticals Inc. for ex-U.S. rights to tovorafenib, an oral drug for pediatric brain tumor that gained U.S. FDA accelerated approval April 23 as Ojemda (tovorafenib).
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