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STAT+: Baby KJ scientists hit road bump in quest to scale custom gene editor

The scientists behind treating Baby KJ say they’ve hit a stumbling block in their efforts to create more custom gene editing treatments for children with rare diseases.

Food and Drug Administration reviewers, they say, are imposing high manufacturing and quality control standards that could make it too expensive and complicated for them — or any academics — to bring such bespoke therapies to approval.

Instead, they warned, such efforts could require the resources of industry.

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The scientists behind treating Baby KJ say they’ve hit a stumbling block in their efforts to create more custom gene editing treatments for children with rare diseases.

Food and Drug Administration reviewers, they say, are imposing high manufacturing and quality control standards that could make it too expensive and complicated for them — or any academics — to bring such bespoke therapies to approval.

Instead, they warned, such efforts could require the resources of industry.

Continue to STAT+ to read the full story…

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Sanofi Bispecific Scores in Asthma, Rhinosinusitis, but Eczema Bet Doesn’t Pay Off

Sanofi Bispecific Scores in Asthma, Rhinosinusitis, but Eczema Bet Doesn’t Pay Off

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Sanofi has faced questions about the potential of lunsekimig in eczema, with executives calling the clinical trial a “measured risk.”​ ​Read More

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STAT+: Gilead to buy cancer biotech Tubulis for more than $3 billion

In a move that will grow its oncology pipeline, Gilead Sciences is spending more than $3 billion to buy the German biotech Tubulis, the companies said Tuesday.

The deal includes an upfront payment of $3.15 billion and up to $1.85 billion more if certain milestones are reached. It also highlights both the therapeutic and commercial promise of antibody-drug conjugates, the next-generation chemotherapy treatments that the privately held Tubulis is developing.

Gilead’s latest move comes just months after it said it would acquire Arcellx in a deal worth $7.8 billion. The two companies had already been working together on a multiple myeloma CAR-T therapy that could be approved later this year. Gilead last month also announced that it was buying Ouro Therapeutics, which is focused on drugs for autoimmune disease, for up to $2.18 billion.

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In a move that will grow its oncology pipeline, Gilead Sciences is spending more than $3 billion to buy the German biotech Tubulis, the companies said Tuesday.

The deal includes an upfront payment of $3.15 billion and up to $1.85 billion more if certain milestones are reached. It also highlights both the therapeutic and commercial promise of antibody-drug conjugates, the next-generation chemotherapy treatments that the privately held Tubulis is developing.

Gilead’s latest move comes just months after it said it would acquire Arcellx in a deal worth $7.8 billion. The two companies had already been working together on a multiple myeloma CAR-T therapy that could be approved later this year. Gilead last month also announced that it was buying Ouro Therapeutics, which is focused on drugs for autoimmune disease, for up to $2.18 billion.

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Gilead continues dealmaking streak with $3.15B Tubulis buy for ADCs

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In its third acquisition of 2026, Gilead is spending $3.15 billion upfront to snag a next-generation antibody-drug conjugate platform from German startup Tubulis.

The California biopharma could pay out another $1.85 billion down the road …

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