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AstraZeneca has reported P-III (LOGOS & KALOS) trial results evaluating Breztri Aerosphere (BGF; 320/28.8/9.6μg or 320/14.4/9.6μg) vs PT009 (ICS/LABA via Aerosphere) & Symbicort pressurized metered-dose inhaler (pMDI) in pts (n=~4400) with uncontrolled asthma
Trial met its 1EP, with BGF 320/28.8/9.6μg showing significant improvement in forced expiratory volume in 1 second (FEV1) AUC 0 to 3hrs. at…
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Merck Animal Health has entered into a binding evaluation & option agreement with AmacaThera to develop long-acting formulations for veterinary use
Collaboration will leverage AmacaThera’s AmacaGel hydrogel platform to develop single-injection veterinary therapeutics with enhanced sustained drug delivery
AmacaGel is a fast-gelling hydrogel composed of 2 established polymers, designed to liquefy under shear force…
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The UK’s MHRA has approved Vimkunya for active immunization against CHIKV disease in individuals (≥12yrs.); launch expected in the summer of 2025. Application submitted to Health Canada, with potential approval anticipated in H1’26
Approval was based on 2 P-III trials (n>3,500) that met their 1EP of rapid immune response within 1wk., with 97.8% of…
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Haleon and Brightseed have partnered to accelerate the discovery of plant-based bioactive compounds using Brightseed’s AI platform, Forager, supporting Haleon to create innovative health solutions
Forager will be directly accessible to Haleon scientists, enabling AI-powered identification of natural compounds and their health-related mechanisms, streamlining R&D and product development
Forager bioactive discovery has already demonstrated…
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OcuSciences has received the US FDA clearance for OcuMet Beacon, a non-invasive confocal scanning ophthalmoscope designed for infrared & autofluorescence imaging of the human retina, with or without the use of a mydriatic agent
Peer-reviewed clinical studies have showed favorable safety & clinical utility of the OcuMet Beacon, with dozen new studies presented at…
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Amylyx has dosed the first participant in its pivotal P-III (LUCIDITY) study of avexitide (90mg) for post-bariatric hypoglycemia (PBH), with recruitment completion expected in 2025 and topline data in the H1’26
The P-III (LUCIDITY) study evaluating avexitide (QD) vs PBO in ~75 PBH patients post Roux-en-Y gastric bypass surgery includes a 6wks. screening…
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The CHMP has recommended Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat patients (≥6yrs.) with cystic fibrosis (CF), having at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Alyftrek is approved in the US and UK and is under review in Canada, Switzerland, Australia, and New Zealand
Vanzacaftor &…
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The US FDA has approved 505(b)(2) NDA of Atzumi (STS101) nasal powder for the acute treatment of migraine with or without aura in adults
Approval was based on a P-I PK trial & P-III (ASCEND) trial, both showing fast absorption, rapid high DHE levels, & sustained DHE plasma concentrations over time
Atzumi utilizes SMART…
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Dimerix has granted Amicus exclusive US rights to develop & market DMX-200 for all indications, incl. focal segmental glomerulosclerosis (FSGS), with Amicus handling regulatory filings, dossier maintenance, & marketing in the US
Dimerix will get $30M cash upfront, ~$75M on FDA approval, $35M on 1st sale, ~$40M for future indications & ~$410M in sales…
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The US FDA has approved Imaavy to treat antibody +ve gMG pts (≥12yrs.) under priority review based on the ongoing P-III (Vivacity-MG3) trial assessing Imaavy + SoC vs PBO + SoC in antibody +ve or -ve adults (N=199; 153 were Ab +ve); global regulatory review is ongoing
Trial showed superior disease control per MG-ADL…

