Methylphenidate

Noramco Announces Submission of Drug Master File for Lisdexamfetamine Dimesylate ─ Active Pharmaceutical Ingredient

Retrieved on: 
Friday, December 3, 2021
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Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient lisdexamfetamine dimesylate (Lisdex/LDX).

Key Points: 
  • Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient lisdexamfetamine dimesylate (Lisdex/LDX).
  • The FDA acknowledged receipt of the submission on November 23, 2021.
  • Noramco has paid the DMF fee required under GDUFA and has completed GMP validation batches.
  • Noramco, headquartered in Wilmington, Delaware, is a leading North American producer of controlled substances bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry.

Vallon Pharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Corporate Update

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PHILADELPHIA, PA, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today reported its financial results for the quarter ended September 30, 2021.

Key Points: 
  • We are pleased with the progress made over the course of the third quarter.
  • Patient enrollment remains ongoing with the final patient visit and completion of treatment expected in the first quarter of 2022 with topline results expected shortly thereafter.
  • Research and development expenses were $0.2 million and $0.7 million for the three months ended September 30, 2021 and 2020, respectively.
  • General and administrative expenses were $1.0 million and $0.3 million for the three months ended September 30, 2021 and 2020, respectively.

Praxis Bioresearch Presents Phase 0 Clinical Data for PRX-P4-003 at 14th Annual CTAD conference

Retrieved on: 
Tuesday, November 9, 2021
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LOS ANGELES, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Praxis Bioresearch reports Clinical Phase 0 study data (PBR001) to demonstrate the desired pharmacokinetic profile for its lead product candidate, PRX-P4-003 in healthy volunteers (NCT04638803).

Key Points: 
  • LOS ANGELES, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Praxis Bioresearch reports Clinical Phase 0 study data (PBR001) to demonstrate the desired pharmacokinetic profile for its lead product candidate, PRX-P4-003 in healthy volunteers (NCT04638803).
  • The PBR001 data are being reported in a virtual poster presentation format at the 14th Clinical Trials on Alzheimer's Disease (CTAD) meeting, being held November 9-12, in Boston, MA.
  • PRX-P4-003 is a new chemical entity (US Patent 10,662,146) designed by Praxis to provide a once-a-day drug to treat apathy caused by Alzheimers disease.
  • Praxis Bioresearch, LLC, is a biopharmaceutical company focused on the discovery and development of therapeutics for chronic neuropsychiatric and neurodegenerative disorders.

BioVie Announces the Appointment of a New Chief Medical Officer

Retrieved on: 
Monday, November 1, 2021
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I am excited to join BioVie and the efforts to develop NE3107 to help Alzheimers and Parkinsons patients.

Key Points: 
  • I am excited to join BioVie and the efforts to develop NE3107 to help Alzheimers and Parkinsons patients.
  • Dr. Palumbo joins BioVie from Zynerba Pharmaceuticals, where he was also Chief Medical Officer responsible for clinical operations, development, regulatory, and medical affairs.
  • BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing therapies to overcome unmet medical needs in chronic debilitating conditions.
  • Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained.

AZSTARYS®, An Innovative ADHD Treatment Developed by KemPharm, to be Featured in a Poster Presentation at the 2021 Psych Congress

Retrieved on: 
Wednesday, October 27, 2021
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CELEBRATION, Fla., Oct. 27, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that research involving AZSTARYS® is being featured in a poster presentation during the 2021 Psych Congress being held both virtually and in-person in San Antonio, Texas, from October 29 through November 1, 2021. The presentation highlights data from clinical studies assessing the relative bioavailability and the steady-state pharmacokinetics (PK) of AZSTARYS.

Key Points: 
  • The presentation highlights data from clinical studies assessing the relative bioavailability and the steady-state pharmacokinetics (PK) of AZSTARYS.
  • The poster, titled, Steady-State Pharmacokinetics and Relative Bioavailability of Serdexmethylphenidate/d-Methylphenidate, a Treatment for Attention-Deficit/Hyperactivity Disorder, Containing a Novel Prodrug of d-Methylphenidate, detailed data from two separate pharmacokinetic studies.
  • We are pleased that data highlighting AZSTARYS were accepted for scientific presentation during the 2021 Psych Congress, said Travis Mickle, Ph.D., President and CEO of KemPharm.
  • The research being presented at the 2021 Psych Congress highlights key attributes of AZSTARYS that could be potentially attractive to prescribers who are seeking innovative treatments for controlling ADHD symptoms.

KemPharm Announces Research Involving AZSTARYS® and Serdexmethylphenidate to be Featured in Poster Presentations at Multiple Medical Conferences during ADHD Awareness Month (October)

Retrieved on: 
Wednesday, October 20, 2021
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Researchers demonstrated that the shape of the PK curves in children and adolescents was similar to that in adults.

Key Points: 
  • Researchers demonstrated that the shape of the PK curves in children and adolescents was similar to that in adults.
  • However, when normalized by dose and body weight, d-MPH exposure levels and PK parameters were comparable between children, adolescents, and adults.
  • Researchers concluded that body weight rather than age is the appropriate scaling factor for d-MPH exposure levels after AZSTARYS dosing in children and adolescents.
  • We are pleased that clinical research involving AZSTARYS and SDX have been accepted for poster presentations during multiple medical conferences in October, coinciding with ADHD Awareness Month, said Travis Mickle, Ph.D., President and CEO of KemPharm.

Vallon Pharmaceuticals Provides Update on Recent Pipeline and Corporate Advancements

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PHILADELPHIA, PA, Oct. 12, 2021 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today provided an update on the progress of its development programs, ADAIR and ADMIR, which leverage the Company’s proprietary technology that is designed to resist manipulation for snorting and provide barriers to injection.

Key Points: 
  • Additionally, we have made important advancements in our second development program, ADMIR, by finalizing the selection of a very promising abuse-deterrent formulation of methylphenidate (Ritalin).
  • In addition, weve strengthened our corporate expertise and leadership with the formation of a scientific advisory board.
  • We believe their knowledge and expertise will be a significant asset and validates our approach to the advancement our CNS-focused, novel abuse-deterrent platform.
  • Vallon Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA.

Corium Receives March 11, 2022 PDUFA Date for New Drug Application for ADLARITY® Patch (donepezil transdermal system) for Treatment of Patients with Alzheimer's Disease

Retrieved on: 
Tuesday, October 12, 2021
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With ADLARITY, Corium has leveraged our innovative Corplex technology to improve the most commonly used first-line treatment for patients with Alzheimer's," said Perry J. Sternberg, President and CEO of Corium.

Key Points: 
  • With ADLARITY, Corium has leveraged our innovative Corplex technology to improve the most commonly used first-line treatment for patients with Alzheimer's," said Perry J. Sternberg, President and CEO of Corium.
  • Corplex enables transdermal therapeutics that incorporate small molecule drugs previously thought incapable of delivery through the skin.
  • Corium is seeking approval of two transdermal ADLARITY doses capable of delivering, respectively, 5 or 10 milligrams of donepezil daily.
  • Corium resubmitted the ADLARITY NDA to address questions asked by the FDA in a July 2020 complete response letter.

Vallon Pharmaceuticals Reports Second Quarter 2021 Financial Results and Provides Corporate Update

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PHILADELPHIA, PA, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today reported its financial results for the quarter ended June 30, 2021.

Key Points: 
  • Looking to the future, we are planning for success and significant value-driving milestones in the months ahead.
  • In the study, subjects are given ADAIR to snort after it has been optimally manipulated using a professional laboratory technique.
  • Research and development expenses were $1.2 million and $0.8 million for the three months ended June 30, 2021, and 2020, respectively.
  • General and administrative expenses were $1.1 million and $0.3 million for the three months ended June 30, 2021, and 2020, respectively.

Praxis Bioresearch Awarded $2.9 Million Fast-Track SBIR Grant for Development of Novel Therapy for Apathy in Alzheimer’s Disease

Retrieved on: 
Thursday, August 5, 2021
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Praxis Bioresearch, a clinical stage biopharmaceutical company is focused on the discovery and development of novel therapeutics for chronic central nervous system disorders.

Key Points: 
  • Praxis Bioresearch, a clinical stage biopharmaceutical company is focused on the discovery and development of novel therapeutics for chronic central nervous system disorders.
  • The funding will support advancement of PRX-P4-003 to early clinical development, said Sandeep Patil, PhD, MD, chief executive officer of Praxis Bioresearch.
  • Praxis Bioresearch, LLC, is a biopharmaceutical company focused on the discovery and development of therapeutics for chronic neuropsychiatric and neurodegenerative disorders.
  • Disclaimer: The SBIR Grant is supported by the National Institute on Aging of the National Institutes of Health under Award Number R44AG066378.