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Pharma & Biotech

Pharma & Biotech

Aptar and Aceso move inhaled ACT-101 RNA therapy toward clinical development in cystic fibrosis

Aptar Pharma’s Nanopharm will develop the formulation and inhalation strategy for Aceso Therapeutics’ preclinical ACT-101 antisense drug, which aims to stabilize CFTR mRNA rather than edit DNA.

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Pharma & Biotech

Insilico rentosertib makes six proteomic aging clocks trend younger in IPF trial

A Nature Biotechnology analysis of 42 rentosertib-treated IPF trial participants found younger predicted biological-age profiles across six proteomic clocks, but researchers caution that the finding does not prove human aging was reversed.

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Pharma & Biotech

Keytruda generated $31.6bn last year. Cipla and Qilu are positioning a biosimilar for the U.S. market

Cipla’s Invagen has licensed U.S. rights to Qilu’s investigational pembrolizumab biosimilar QL2107, setting up a future challenge to Merck’s blockbuster Keytruda franchise.

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Pharma & Biotech

GLP-1 prescribing rises 310-fold among U.S. children aged 8–11 with obesity

An NYU Langone study of more than 3.5 million children found rapidly increasing off-label GLP-1 prescribing below age 12, concentrated among children with severe obesity and related disease.

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Pharma & Biotech

Menarini licenses biweekly GLP-1 bofanglutide in Europe in deal worth up to €726m

Menarini has licensed European rights to Gan & Lee’s twice-monthly GLP-1 bofanglutide after a 640-patient Phase 3 study produced up to 18.54% mean weight loss at 52 weeks.

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Pharma & Biotech

Clover triple respiratory vaccine triggers RSV, hMPV and PIV3 antibodies in 420-patient Phase 2

Clover’s 420-patient Phase 2 trial found strong antibody responses to RSV, hMPV and PIV3 with no apparent immune interference, supporting further development of its multi-virus vaccines for older adults.

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Pharma & Biotech

FDA supports key NewRal trial design elements as Matricelf prepares spinal cord injury IND

FDA feedback supports major elements of Matricelf’s proposed first-in-human NewRal study in chronic complete thoracic spinal cord injury while requesting additional IND information.

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Pharma & Biotech

Novartis pelacarsen fails 8,323-patient Phase 3 Lp(a)HORIZON cardiovascular trial

Novartis and Ionis say pelacarsen substantially reduced lipoprotein(a) but failed to reduce major cardiovascular events in the 8,323-patient Phase 3 Lp(a)HORIZON trial.

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Pharma & Biotech

Sanofi backed KT501 for up to $1.23bn. FDA has now opened the U.S. trial path

Kali Therapeutics has received FDA IND clearance for KT501, a CD19xBCMAxCD3 trispecific T-cell engager designed to produce deep B-cell and plasma-cell depletion in autoimmune disease.

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Pharma & Biotech

Mabwell reports 81% fewer COPD exacerbations at highest 9MW1911 dose. Why the number needs caution

Mabwell’s 80-patient Phase 1b/2a COPD trial showed an 81% numerical reduction in moderate-to-severe exacerbations at the highest 9MW1911 dose, supporting Phase 2b and planned Phase 3 development.

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