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INSIGHTS+

EMA Marketing Authorization of New Drugs in August 2026

Shots:  The European Commission (EC) approved Daybu (trofinetide) and Hopledo (modified-release levodopa/carbidopa) for neurological disorders, expanding treatment options for Rett syndrome and Parkinson’s disease, respectively.  Daybu was approved for neurobehavioral symptoms of Rett syndrome in patients aged ≥5 years, while Hopledo was approved for adults with Parkinson’s disease and moderate to severe motor fluctuations.  The…
September 15, 2026

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MannKind and Rose Pharma Partner to Develop ROSE-010 Technosphere for Weight Management

Shots: Rose received exclusive global rights to MannKind’s Technosphere tech to develop & commercialize ROSE-010 Technosphere, a rapid-acting GLP-1 receptor agonist, with initial work focused on formulation re-establishment & optimization, followed by nonclinical & regulatory development MannKind will receive equity in Rose Pharma, the right to receive royalties on potential future net sales & board…
September 9, 2026

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Aptar and Aceso Therapeutics Collaborate to Advance Inhaled ASO Therapy for Cystic Fibrosis

Shots: Aptar Pharma and Aceso Therapeutics have entered into a collaboration to advance ACT-101, an antisense oligonucleotide (ASO) candidate designed to target underlying disease mechanisms of cystic fibrosis (CF) Aptar Pharma’s specialist inhalation development services business; Nanopharm will lead formulation development and device assessment activities to support clinical development of ACT-101 The collaboration combines Nanopharm’s…
September 8, 2026

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Evinova Partners with Lothar Medical to Advance Respiratory Clinical Trials Globally

Shots: Evinova has partnered with Lothar Medical to integrate Lothar’s respiratory device with Evinova’s Unified Trial Solution, supporting connected, data-rich respiratory clinical trials globally Lothar’s 3-in-1 device combines FeNO, spirometry & oscillometry, while Evinova’s GxP-validated platform helps streamline traditional, hybrid & DCTs across 4,000+ sites in 54 countries The partnership aims to accelerate patient recruitment…
September 7, 2026

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Novartis and Alteogen Partner for ALT-B4 to Advance SC Formulations of Multiple Products

Shots: Alteogen has entered into an option & license agreement with Novartis for the development & commercialization of SC products leveraging ALT-B4 powered by Alteogen's Hybrozyme tech As per the deal, Novartis can obtain exclusive rights to develop & commercialize SC formulations of multiple products using Alteogen’s ALT-B4, with Alteogen eligible for ~$3.223B in option…
September 3, 2026

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Evotec and Plectonic Partner on Next-Generation T-Cell Engagers for Solid Tumors

Shots: Evotec and Plectonic Biotech have entered a research collaboration to explore a novel immunotherapy approach for solid tumors by combining Plectonic’s programmable Logibody technology with Evotec’s BiTco platform Plectonic’s Logibody uses multi-antigen tumor signatures to selectively activate T cells, while Evotec’s BiTco platform uses a non-blocking CD2 antibody to enhance T-cell activity, tumor killing…
September 2, 2026

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Styx Biotechnologies Partner with ZoeNCure Therapeutics to Advance ADC Development

Shots: Styx Biotechnologies has entered into a strategic agreement with ZoeNCure Therapeutics to accelerate selected Styx ADC programs toward first-in-human clinical studies for multiple solid tumor indications The collaboration gives Styx a capital-efficient path to advance selected ADC assets through coordinated preclinical, CMC, regulatory & clinical activities while preserving opportunities for global development & strategic partnering As…
September 2, 2026

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Ascendis Pharma and BioMarin Reach Global Settlement for Yuviwel

Shots: Ascendis Pharma has entered into a binding term sheet with BioMarin for a global settlement & license agreement covering Yuviwel (navepegritide) & related products, resolving ongoing litigation & disputes between the companies As per the deal, BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license to research, develop, manufacture & commercialize navepegritide-related products without…
September 1, 2026

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