Amylyx’s $35m-acquired PBH drug meets endpoints in Phase III trial
Amylyx Pharmaceuticals’ $35m bet on Eiger BioPharmaceuticals’ glucagon-like peptide-1 (GLP-1) receptor antagonist for post-bariatric hypoglycaemia (PBH) has paid off after …
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Trump expected to nominate Heidi Overton as new FDA commissioner
US President Donald Trump is expected to put forward Heidi Overton as his choice for the next commissioner of the …
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Abcuro secures $66m to support clinical trial of ulviprubart for IBM
US-based biotechnology company Abcuro has closed a $66m Series D funding round to support its new clinical trial of ulviprubart …
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Enrolment concludes in Lynch’s Phase II rhPDGF-BB study
Lynch Regenerative Medicine has completed participant enrolment in a Phase II clinical trial assessing the recombinant human pure platelet-derived growth …
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EyePoint’s Duravyu falls short to Eylea in Phase III trial
EyePoint’s stock dropped 67% after its potential Eylea (aflibercept) competitor Duravyu fell short in a Phase III trial that pitted …
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United Therapeutics completes enrolment for TETON-PPF trial
United Therapeutics has completed enrolment for its TETON-PPF study, assessing the safety and efficacy of the Tyvaso (treprostinil) inhalation solution …
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Long-acting HIV therapies gain momentum, but pricing and access challenges remain
The HIV treatment landscape is undergoing a period of significant innovation, with long-acting therapies offering the potential to reduce pill …
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Leal Therapeutics raises $30m to fund schizophrenia and ALS trials
Leal Therapeutics has completed a $30m extension of its Series A financing to support advancement of its investigational therapies for …
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Argenx’s stock rises on Phase III autoimmune myositis victory
Argenx’s stock opened 8.9% up after a Phase III trial of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with …
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Sustaining long-term follow-up in cell and gene therapies
Diego Correa, VP and global head, CAGT Center of Excellence, IQVIA, and Jip Klerks, product strategy lead, real-world solutions at …
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AstraZeneca axes NSCLC trial after bispecific deemed unlikely to best Keytruda
AstraZeneca has ended a Phase III trial of its bispecific volrustomig pitted against MSD’s blockbuster Keytruda (pembrolizumab) in non-small cell …
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Fate Therapeutics begins Phase II trial of FT819 for lupus nephritis
Fate Therapeutics has initiated and treated the first patient in RECLAIM-LN, a Phase II clinical trial evaluating FT819 in patients …
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FDA approves ArkBio’s ziresovir for Phase II trial in severe RSV
Shanghai Ark Biopharmaceutical (ArkBio) has received approval from the US Food and Drug Administration (FDA) to begin a Phase II …
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ICH GCP Annex 2 will strengthen sponsor confidence in the use of DCTs and RWD
In July 2026, the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) quietly …
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Barriers stopping US biotechs from running FIH trials on home soil
A survey indicates that US biotechs would prefer to conduct first-in-human (FIH) trials in the US, but obstacles are pushing …
