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BioWorld - Saturday, December 20, 2025
Home » Topics » Europe, BioWorld

Europe, BioWorld
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Red and blue bispecific antibodies

Genmab adding late-stage bispecific in $8B Merus acquisition

Sep. 29, 2025
By Jennifer Boggs
No Comments
Genmab A/S is paying $8 billion to acquire Merus NV, gaining rights to the latter’s phase III-stage petosemtamab, a bispecific antibody initially in development for head and neck cancer, and continuing the firm’s strategy to transition from a royalty-based operation to a fully integrated biopharma.
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100 percentage illustration

Trump hits drug imports with 100% tariffs, starting Oct. 1

Sep. 26, 2025
By Nuala Moran and Karen Carey
No Comments
The threat of tariffs on imports of branded drugs is about to be realized after U.S. President Donald Trump announced a 100% import duty will apply beginning Oct. 1. However, the flurry of recent announcements by pharma companies of investments in U.S. manufacturing plants may have paid off, with the president saying in his announcement on Truth Social that the 100% rate will be enforced “unless a company is building their manufacturing plant in America.”
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Kidneys

Hansa’s imlifidase enables transplants for advanced kidney disease

Sep. 25, 2025
By Nuala Moran
No Comments
Hansa Biopharma A/S has turned in positive data from a pivotal U.S. phase III trial of imlifidase, an enzyme that speedily removes antibodies from the bloodstream, enabling highly sensitized kidney patients to have transplants.
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Fibroblast illustration

Human Cell Atlas discovers new targets in skin fibroblast subtypes

Sep. 24, 2025
By Nuala Moran
No Comments
The Human Cell Atlas project has delivered a fresh tranche of data mapping fibroblasts in healthy and diseased skin and pointing to drug targets with potential in multiple diseases across a range of tissues. Using single cell sequencing and spatial genomics, a technique for showing how gene expression varies at different locations within a tissue, nine different subpopulations of fibroblasts were identified, six in healthy skin and three in disease samples.
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AI-generated art of brain connections

Hunting down Huntington’s: Uniqure’s pivotal win

Sep. 24, 2025
By Randy Osborne
No Comments
Uniqure NV rang the bell with a best-case scenario in the pivotal phase I/II study with AMT-130 for the treatment of Huntington’s disease, and shares of the Amsterdam-based firm (NASDAQ:QURE) closed Sept. 24 at $47.50, up $33.84, or 248%. The study met its prespecified primary endpoint, with high-dose AMT-130 turning up a statistically significant slowing of disease progression as measured by the composite Unified Huntington’s Disease Rating Scale at 36 months compared to a propensity score-matched external control.
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Handshake, money, calculator, MA-letters

Biotech leaders: Macroeconomics, US policy shifts making M&A harder

Sep. 23, 2025
By Nuala Moran
No Comments
The unsettling impact that the Trump administration’s health care and tariff initiatives are having on M&A activity and financing is highlighted in a new survey of CEOs and investors, who say uncertainty related to the U.S. policy environment is the top challenge they face when it comes to executing deals.
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Psychedelic drug- brain illustration

UK college offers guidance, clarity for psychedelic research

Sep. 22, 2025
By Nuala Moran
No Comments
The Royal College of Psychiatrists in the U.K. has published its first-ever guidance to support research into psychedelic drugs as therapies for conditions including treatment-resistant depression, substance abuse disorders and posttraumatic stress disorder, saying that in a fast-moving field there is a risk of jumping ahead of the evidence.
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Person holding pills and glass of water

CHMP recommends EU approval of Bayer’s Lynkuet for hot flashes

Sep. 19, 2025
By Nuala Moran
No Comments
Following the first approvals in the U.K., Canada, Australia and Switzerland, the EMA’s Committee for Medicinal Products for Human Use (CHMP) is now recommending approval of Bayer AG’s Lynkuet (elinzanetant), a non-hormonal treatment for symptoms of menopause. The drug, the first dual neurokinin-1 and neurokinin-3 receptor antagonist, is for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes.
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Acquisition puzzle

MASH dash speeds up as Roche acquires 89bio for up to $3.5B

Sep. 18, 2025
By Nuala Moran
No Comments
The dash for MASH is gaining momentum, with Roche AG acquiring 89bio Inc. and its phase III FGF21 analogue, pegozafermin, for treating metabolic dysfunction-associated steatohepatitis, in a deal worth up to $3.5 billion. The Swiss pharma is to pay $14.50 per share, valuing San Francisco-based 89Bio at $2.4 billion, a premium of approximately 52% to 89bio’s 60-day average price on Sept. 17, 2025. Shares of 89bio (NASDAQ:ETNB) gained $6.88, or 85%, to close Sept. 18 at $14.96.
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Silhouette of person walking with a cane

Roivant, Priovant plan NDA on positive dermatomyositis data

Sep. 17, 2025
By Jennifer Boggs
No Comments
With positive phase III results in hand, Roivant Sciences Ltd. and Priovant Therapeutics Inc. anticipate an NDA filing in the first half of 2026, seeking approval for brepocitinib, a dual inhibitor of tyrosine kinase 2 and JAK1, in dermatomyositis, a rare autoimmune disease with limited treatment options.
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