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Teva Welcomes Potential For Olanzapine ‘Running Start’ Amid Positive Clinical Data

No New Safety Signals Identified And No PDSS Events Reported To-Date, Initial Data Shows

 
• By Dean Rudge

Buoyed by the success of its long-acting risperidone injectable, Teva is continuing to feel upbeat about the potential for its olanzapine LAI candidate, ahead of a full study safety readout anticipated in the first half of 2025.

Next Level
• Source: Shutterstock

Teva has welcomed positive initial data from its Phase III clinical trial evaluating a proposed olanzapine long-acting injectable as something “we have not seen to-date,” as the Israeli firm confirmed that the development program – in partnership with MedinCell – was “right on track.”

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Teva Shares Encouraging Patient Survey Data For Long-Acting Olanzapine

 
• By Adam Zamecnik

Doubling down on previously shared data from the firm’s STELARIS trial, Teva has reported further findings from a survey featuring subjects and professionals involved in the Phase III study for its proposed long-acting olanzapine injectable.

Cipla Becomes Formosa’s Latest Clobetasol Partner With 11-Country Deal

 
• By Dean Rudge

Cipla has bolstered its ophthalmology portfolio and increased its global offering after chalking up an agreement to add Formosa Pharmaceuticals’ USFDA-approved clobetasol propionate 0.05% ophthalmic suspension.

Amneal’s Rytary Follow-On Crexont Could Hit $500m In Sales

 
• By Dean Rudge

Amneal has spoken excitedly about its Crexont (carbidopa/levodopa) extended-release capsules as the Parkinson’s disease drug passes six months on the market.

Hyloris Celebrates Valacyclovir FDA Filing Amid Series Of Announcements

 
• By Adam Zamecnik

Following steady updates on its development of a new formulation of valacyclovir, Hyloris revealed the US FDA’s acceptance of its NDA filing while also announcing three new deals this month.

More from Generics Bulletin

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

Who’s Hired? Botox Biosimilar Developer Aeon Takes CEO From Rival Revance

 
• By Dave Wallace

Aeon Biopharma has picked up Revance Therapeutics executive Rob Bancroft to serve as its new CEO as it continues to pursue a biosimilar version of Botox. Meanwhile, Coherus has lost its chief commercial officer, as Viatris, Sandoz and Medicines for Ireland have announced new appointments.

OGD’s Policy Office Cut To Have ‘Profound’ Impact On New Generic Approvals, Warns Former FDA Head Gottlieb

 
• By Urtė Fultinavičiūtė

The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.