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Neurology

Sage Prioritizes Zurzuvae For PPD, Ends MDD Effort, Drops Zulresso

Sage Prioritizes Zurzuvae For PPD, Ends MDD Effort, Drops Zulresso

As Sage prioritizes Zurzuvae for postpartum depression after recent setbacks, it will stop selling Zulresso for PPD and no longer pursue Zurzuvae in major depressive disorder.

7 Start-Ups At HLTH 2024: Shaking Up Medtech’s Business Model, ‘AI’ For Cancer Detection, MCI Assessment, Validation, Monitoring

7 Start-Ups At HLTH 2024: Shaking Up Medtech’s Business Model, ‘AI’ For Cancer Detection, MCI Assessment, Validation, Monitoring

Medtech Insight was on the ground at HLTH looking for innovative companies. Learn about seven start-ups using AI to help physicians detect conditions including prostate and breast cancers, seizures and heart failure; assess patients for cognitive decline validate and deploy algorithms, and monitor patients in and out of the hospital.

Eisai Fights Back After Australia Rejects Alzheimer's Drug Leqembi

Eisai Fights Back After Australia Rejects Alzheimer's Drug Leqembi

The Therapeutic Goods Administration appears to share similar safety concerns regarding Leqembi as those expressed by the European Medicines Agency when it rejected the drug in July.

EMA Schedules High-Stakes Meetings With Drug Makers

EMA Schedules High-Stakes Meetings With Drug Makers

The sponsors of medicines that are nearing the end of the regulatory review cycle in the EU could this week be asked to explain why the European Medicines Agency should recommend approving their products.

EU Decision Time For Hemophilia Drug Concizumab & 10 Other Products

EU Decision Time For Hemophilia Drug Concizumab & 10 Other Products

Concizumab sponsor Novo Nordisk and a number of other companies could soon learn whether or not the European Medicines Agency will give their respective drugs the marketing thumbs up.

Sanofi RIPK1 Drug Receives Last Rites

Sanofi RIPK1 Drug Receives Last Rites

The French major and partner Denali's attempts to validate RIPK1 as a promising target have once again foundered as oditrasertib comes up short in a multiple sclerosis trial months after a failure in amyotrophic lateral sclerosis.

Marabio Systems Raised $19M In Series A For Blood Test To Detect Autism

Marabio Systems Raised $19M In Series A For Blood Test To Detect Autism

Marabio Systems says the new funding will help accelerate efforts to bring a blood test to market in 2025 that will accurately determine if a mother is a carrier of antibodies that cause MARA, a subtype of autism that believe to cause more severe behavior.

Long-Term Benefits Put PTC Friedreich’s Ataxia Drug Back On Track

Long-Term Benefits Put PTC Friedreich’s Ataxia Drug Back On Track

While vatiquinone may have missed its primary endpoint in a Phase III trial, PTC is ready to file the drug for the debilitating, life-shortening disorder after showing that it slowed disease progression over 144 weeks.

Some Perspectives From Medtech Industry Leaders Heard At Octane OC

Some Perspectives From Medtech Industry Leaders Heard At Octane OC

The Octane Medical Innovation Forum brought together industry experts, entrepreneurs and investors to discuss a range of topics. Medtech Insight was on the ground to bring some memorable perspectives from industry leaders.

Janssen’s Nipocalimab Among Six New EU Filings

Janssen’s Nipocalimab Among Six New EU Filings

Nipocalimab is an investigational FcRn blocker for treating generalized myasthenia gravis that was also recently filed for regulatory review in the US.