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Lead Product(s): Serdexmethylphenidate,Dexmethylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Azstarys
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 03, 2021
Details:
AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH. After absorption via the gastrointestinal tract, SDX is converted to d-MPH with a design to gradually release d-MPH throughout the day.
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Lead Product(s): Psilocybine
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 02, 2021
Details:
Significant progress made as Numinus-sponsored PRIME study on psilocybin-assisted psychotherapy for opioid, stimulant and/or alcohol use disorders enters pre-implementation stage.
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Lead Product(s): Nortriptyline
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2021
Details:
Zydus Cadila has received final approval from the United States Food and Drug Administration (USFDA) to market Nortriptyline Hydrochloride capsules USP, in strengths of 10 mg, 25 mg, 50 mg and 75 mg, Cadila Healthcare said in a regulatory filing.
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Lead Product(s): S-Ketamine
Therapeutic Area: Psychiatry/Psychology Product Name: Spravato
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 08, 2021
Details:
The European Commission (EC) has authorised the expanded use of Janssen’s Spravato (esketamine nasal spray), co-administered with oral antidepressant therapy in adults with a moderate to severe episode of major depressive disorder (MDD).
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Lead Product(s): Tadalafil
Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 31, 2020
Details:
Glenmark Pharmaceuticals Ltd has received final approval from the United States Food and Drug Administration (USFDA) for Tadalafil tablets USP in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg, the company said in a regulatory filing.
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Lead Product(s): Buprenorphine Hydrochloride,Naloxone Hydrochloride
Therapeutic Area: Psychiatry/Psychology Product Name: Zubsolv
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 30, 2020
Details:
The new patent, US Patent further strengthens the company's intellectual property for ZUBSOLV® in the US. Orexo will now have six patents listed in the Orange Book for ZUBSOLV®.
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Lead Product(s): Asenapine Maleate
Therapeutic Area: Psychiatry/Psychology Product Name: Secuado
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
Details:
SECUADO achieved the primary endpoint, demonstrating statistically significant improvement in Positive and Negative Syndrome Scale (PANSS) total score change from baseline to Week 6 compared to placebo.
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