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If Data Is the New Oil, AI Is the Refinery
The 2025 Bioprocessing Summit revealed knowledge gaps and changing mindsets. As some companies look towards the future, others struggle with the present and past.
September 8, 2025
·
4 min read
·
Lori Ellis
Neuroscience
Alkermes One Ups Takeda in Narcolepsy, Clearing Cognitive Impairments in Mid-Stage Trial
Presenting at the World Sleep Congress 2025, the Dublin-based company’s Phase II study bested Takeda drug in both efficacy and safety.
September 8, 2025
·
2 min read
·
Dan Samorodnitsky
FDA
FDA Demurs on GLP-1 Compounding Fight, Debuts Consumer ‘Green List’ Instead
While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.
September 8, 2025
·
2 min read
·
Annalee Armstrong
Neuroscience
Rapport Jumps 180% on ‘Best Case’ Mid-Stage Data for Epilepsy Pill
Shares of Rapport Therapeutics popped Monday morning after Phase IIa data for RAP-219 exceeded analyst and Wall Street expectations, reducing seizures by almost 78% in patients with drug-resistant focal onset seizures.
September 8, 2025
·
2 min read
·
Heather McKenzie
Lung cancer
Summit’s Keytruda Challenger Hits Cross-Country Consistency Problems, Raising US Approval Questions
Ivonescimab elicited better overall survival in Asian patients with non-small cell lung cancer than in those from North America and European countries, in Western countries narrowly missing the statistical significance threshold the FDA is seeking.
September 8, 2025
·
2 min read
·
Tristan Manalac
Sponsored
WHITE PAPER: Validated devices for easy self-collection and stabilization of vaginal microbiome samples
The vaginal microbiome plays a critical role in women’s health, from infection resistance to fertility, yet it continues to remain underexplored. With DNA Genotek™’s OMNIgene™•VAGINAL collection kit, researchers and innovators are empowered to collect stablized samples with precision to support women’s healthcare research and development of healthcare for women.
September 8, 2025
·
1 min read
Press Releases
Envoy Medical to Present at the H.C. Wainwright 27th Annual Global Investment Conference on September 8-10, 2025
September 8, 2025
·
6 min read
Press Releases
Proscia Unveils Aperture, Making the Moment of Diagnosis the Gateway to Life-Saving Treatments for More Patients
September 8, 2025
·
1 min read
Neuroscience
Servier Bets $450M On Kaerus’ Fragile X Syndrome Therapy
KER-0193 is a modulator of ion channels connected to autism spectrum disorder. The FDA bestowed orphan drug and rare pediatric drug designations on the candidate earlier this year.
September 8, 2025
·
2 min read
·
Tristan Manalac
Lung cancer
Merck, Daiichi Sankyo Stage Lung Cancer Rally With ‘Strong’ Pivotal Data for I-Dxd
According to analysts, the new data could present a path to accelerated approval for ifinatamab deruxtecan, a product of Merck and Daiichi Sankyo’s troubled ADC partnership.
September 8, 2025
·
2 min read
·
Tristan Manalac
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