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NEWS

Viz.ai Partners with Cortechs.ai to Expand AI Platform into Neurodegenerative Disease Care

Shots: Viz.ai has partnered with Cortechs.ai to integrate its NeuroQuant & NeuroQuant MS into its AI-powered care coordination platform, expanding into neurodegenerative diseases The collaboration will initially focus on multiple sclerosis by integrating Cortechs.ai’s quantitative MRI analysis into Viz.ai’s clinical workflow & care coordination platform to improve MS identification, characterization, & management The company plans…
2 days ago

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NEWS

Splash Licenses Argent BioPharma’s CannEpil for Global Epilepsy Rights

Shots: Splash secured exclusive global rights to develop & commercialize CannEpil for drug-resistant epilepsy, refractory epilepsy, seizure disorders, & related neurological conditions, incl. future product improvements & next-generation formulations Splash secured a $1M strategic investment from C/M Capital Partners, while Mercer Street forgave ~$5M in Argent BioPharma debt and Splash issued $5.5M in preferred equity…
July 7, 2026

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Axsome
NEWS

Axsome Therapeutics Reports the US FDA Approval of Auvelity to Treat Agitation Associated with Alzheimer’s Dementia

Shots: The US FDA has approved Auvelity (dextromethorphan HBr & bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease Approval was supported by an extensive clinical program incl. P-III (ADVANCE-1 & ACCORD-2), where ADVANCE-1 evaluated Auvelity vs PBO or bupropion over 5wks., while ACCORD-2 assessed Auvelity vs PBO in known responders In…
May 1, 2026

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NEWS

Tanabe Pharma Report the EC Approval of Onerji for Parkinson’s Disease (PD) 

Shots:  The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm   Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the…
April 27, 2026

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INSIGHTS+

2025 EMA Drug Approvals Outlook: A Year of Intentional, Biology Led Medicine Across Europe 

Shots:  EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion  Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…
January 22, 2026

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Axsome
NEWS

Axsome Therapeutics Reports the US FDA’s sNDA Acceptance with Priority Review of AXS-05 for the Treatment of Alzheimer’s Disease Agitation

Shots: The US FDA has accepted sNDA & granted priority review to AXS-05 (dextromethorphan HBr and bupropion HCl) to treat Alzheimer’s disease agitation (PDUFA: April 30, 2026) The sNDA reflects AXS-05’s clinical development program in Alzheimer’s disease agitation, which included four randomized, double-blind P-III trials and a long-term safety study AXS-05 is an oral investigational…
January 1, 2026

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NEWS

INBRAIN Neuroelectronics Partners with Microsoft to Advance AI-Enabled Brain-Computer Interface Therapeutics

Shots: INBRAIN Neuroelectronics has entered into a strategic collaboration with Microsoft to apply agentic AI powered by Microsoft’s cloud & data infrastructure to enhance real-time precision neurology & next-gen brain-computer interface (BCI) therapeutics The partnership will leverage Microsoft’s Azure AI infrastructure, incl. time-series large language models & data analytics with INBRAIN’s graphene-based neural platform, allowing…
November 11, 2025

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NEWS

Merz Therapeutics Enrolls First Patients in P-III Studies Evaluating Xeomin for Migraine Prevention

Shots: Merz Therapeutics has enrolled the first patients in two global P-III studies, MINT-E (episodic migraine, ~990 pts) and MINT-C (chronic migraine, ~780 pts), evaluating the efficacy and safety of Xeomin (incobotulinumtoxinA) for migraine prevention Both studies will recruit ~1,770 adults across 120 sites in North America & Europe, and recruitment in Europe is expected…
August 26, 2025

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NEWS

DoveTree Medicines Enters a ~$5.99B Deal with XtalPi to Discover Novel Therapeutics Across Various Indications

Shots: XtalPi has entered into a strategic collaboration with DoveTree Medicines to identify novel therapeutics across oncology, immunology, inflammation, neurology, & metabolic diseases, leveraging XtalPi's de novo drug discovery platform As per the deal, DoveTree will gain exclusive global rights to develop & commercialize multiple therapeutics from the collaboration, in exchange for a $51M upfront,…
August 8, 2025

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