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Repare Therapeutics & DCx Biotherapeutics
News

Repare Therapeutics Out-Licenses its Discovery Platforms to DCx Biotherapeutics

Shots: Repare has out-licensed its discovery platform incl. SNIPRx, SNIPRx-surf, & STEP2 , along with certain intellectual property to DCx As per the deal, Repare will get $4M as upfront & near-term payments, 9.99% equity in DCx with dilution protection, & future potential out-licensing, clinical & commercial milestones, with low-single digit tiered sales royalties; Repare will…
May 2, 20250Comments

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Astrazeneca
News

AstraZeneca Reports P-III (LOGOS & KALOS) Trial Findings of Breztri Aerosphere for Uncontrolled Asthma

Shots: 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…
May 2, 20250Comments

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Merck Animal Health & AmacaThera
News

Merck Animal Health Collaborates with AmacaThera to Develop Long-Acting Injectable Formulations for Veterinary Use

Shots: 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…
May 2, 20250Comments

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Brightseed and Haleon
News

Brightseed and Haleon Collaborate to Discover Small Molecule for Human Health Innovation by Leveraging AI Platform Forager

Shots: 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…
May 2, 20250Comments

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OcuSciences
News

OcuSciences’ OcuMet Beacon Receives the US FDA Clearance for Retinal Health Assessment

Shots: 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…
May 2, 20250Comments

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Amylyx
News

Amylyx Pharmaceuticals Reports the First Participant Dosing in P-III (LUCIDITY) Study Evaluating Avexitide in PBH

S Shots: 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…
May 1, 20250Comments

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Vertex Pharmaceuticals
News

Vertex Pharmaceuticals’ Alyftrek Receives the CHMP’s Positive Opinion for the Treatment of Cystic Fibrosis

S R Shots:    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 &…
May 1, 20250Comments

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Satsuma Pharmaceuticals
News

Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine

Shots: 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…
May 1, 20250Comments

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Amicus Therapeutics & Dimerix
News

Amicus Therapeutics Enters a ~$590M Exclusive License Agreement with Dimerix for DMX-200

Shots: 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…
May 1, 20250Comments

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