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Novaliq’s dry eye disease therapy receives US FDA approval

Pharmaceutical Technology

Biopharmaceutical company Novaliq has received approval from the US Food and Drug Administration (FDA) for VEVYE (cyclosporine ophthalmic solution) 0.1% VEVYE, the development name of which is CyclASol, is a cyclosporine, solubilised solution in a new, water-free excipient. to treat the signs and symptoms of dry eye disease.

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Drug developers look at innovative mechanisms to tackle dry eye syndrome

Pharmaceutical Technology

While a handful of therapies have launched since then, late-stage pipeline therapies that are currently in development reveal that drug developers are exploring a broad set of mechanisms of action (MOAs), many of which are innovative, to tackle DES. Novaliq’s CyclASol (0.1%

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Luye claims its first FDA approval, for bi-weekly schizophrenia drug

pharmaphorum

China’s Luye Pharma has claimed its first FDA approval, getting a green light for Rykindo, an injectable formulation of the antipsychotic risperidone given every two weeks. ” The post Luye claims its first FDA approval, for bi-weekly schizophrenia drug appeared first on.

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PureTech Reveals New CBD Pill to Rival Jazz’s Epidiolex

XTalks

Clinical-stage biotech company PureTech Health has announced it has developed a new oral CBD therapeutic candidate with improved bioavailability and tolerability, which could expand use of the CBD prodrug in a wide range of indications and age groups. Jazz bought out Epidiolex developer GW Pharmaceuticals for the drug in a whopping $7.2

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

Clinical research experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Why is it Difficult to Develop CNS Therapeutics? During the webinar, Dr. Vornov discussed a few developments in targeted CNS delivery, which are summarized below.

Trials 83
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Orserdu (elacestrant) Approved for Patients with ESR1 mutations in ER+/HER2- Advanced or Metastatic Breast Cancers

XTalks

Until now, fulvestrant was the only other selective estrogen receptor degrader (SERD) therapy approved for ER+ breast cancer, delivered via intramuscular injections. This approval follows the promising results of the Phase III EMERALD global clinical trial published in the Journal of Clinical Oncology.

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Vevye: A New Cyclosporine Solution for Dry Eye Disease

XTalks

The clinical trials consistently showed significant therapeutic improvements in ocular surface damage and associated symptoms, while pioneering visual function improvement analysis”, said John D. “The Attendees will understand best practices for novel drug delivery design and development. What Is Dry Eye Disease?