Carbidopa

Amneal and BIAL Announce U.S. Licensing Agreement for ONGENTYS® (opicapone)

Retrieved on: 
Thursday, December 7, 2023
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Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal”) and BIAL - Portela & Ca., S.A. (“BIAL”), today announced a licensing agreement where Amneal will have exclusive rights to market and distribute ONGENTYS® (opicapone) in the U.S. starting on December 18, 2023.
  • Carbidopa/levodopa (CD/LD), which works to control the symptoms of PD, has been the gold-standard treatment for PD since the 1970s.
  • ONGENTYS® works by inhibiting the COMT enzyme – which breaks down LD – making more LD available to reach the brain, thereby reducing “Off” time.
  • The financial terms of the agreement were not disclosed, and any incremental expenses associated with this product are contemplated within Amneal’s guidance.

Neumora Therapeutics Announces Appointment of Robert Lenz, M.D., Ph.D., as Executive Vice President, Head of Research and Development

Retrieved on: 
Tuesday, October 10, 2023
DSM-IV codes, Asthma, Amgen, Neuropsychiatry, Research, Carbidopa, Brain, Therapy, L-DOPA, MDD, Migraine, Patient, Management, Fine chemical

WATERTOWN, Mass., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced the appointment of Robert Lenz, M.D., Ph.D., as executive vice president, head of research and development.

Key Points: 
  • WATERTOWN, Mass., Oct. 10, 2023 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced the appointment of Robert Lenz, M.D., Ph.D., as executive vice president, head of research and development.
  • Dr. Lenz is a member of Neumora’s Executive Team reporting to Henry Gosebruch, chief executive officer.
  • “I am delighted to welcome Rob to the Neumora team.
  • “I am excited to join Neumora’s strong team of R&D leaders, and to leverage my expertise to advance our industry-leading pipeline of novel neuropsychiatry and neurodegeneration programs,” said Dr. Robert Lenz, executive vice president, head of research and development, Neumora.

Evecxia Therapeutics Reports No Toxicology Findings in Nonclinical GLP Studies of Adjunctive EVX-101

Retrieved on: 
Monday, October 2, 2023
Biotechnology, Health, Women, Pharmaceutical, Men, Mental Health, Other Science, Research, Consumer, Science, Clinical Trials, GLP, Rat, Human, Depression, Diet, Fluoxetine, Safety, Pharmacokinetics, Toxicity, DSM-IV codes, Plasma, Patient, Carbidopa, Hematology, Toxicology, Serotonin, FDA, Therapy, SSRI, Urinalysis, Pharmaceutical industry

Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat brain disorders, today announced the absence of toxicity findings associated with the co-administration of EVX-101 in conjunction with the first-line antidepressant fluoxetine in nonclinical GLP toxicology studies.

Key Points: 
  • Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat brain disorders, today announced the absence of toxicity findings associated with the co-administration of EVX-101 in conjunction with the first-line antidepressant fluoxetine in nonclinical GLP toxicology studies.
  • EVX‑101 is being developed as an adjunctive treatment for depression when first-line SSRI/SNRI antidepressants alone are inadequate.
  • The absence of toxicological findings in the nonclinical GLP studies are consistent with the favorable historical safety profile of 5‑HTP administration across more than 100 human clinical studies conducted over the past six decades.
  • The results from our nonclinical GLP toxicology studies strongly support our mission to bring safer and potentially more effective treatments to patients suffering from disabling neuropsychiatric disorders.

BioVie Presents Data for NE3107 at 2023 International Congress of Parkinson’s Disease and Movement Disorders

Retrieved on: 
Monday, August 28, 2023
Neuroprotection, PK, Insulin resistance, PD, Clinical trial, Pharmacokinetics, Cmax, Amantadine, Movement disorder, MDS, Hydrogen chloride, Carbidopa, Randomness, AUC, L-DOPA, Poster, Carbidopa/levodopa, Locomotion, International Congress on Tuberculosis, Ingrid, Safety, Neuroinflammation, Pharmaceutical industry, Medical device, Patient

Results showed that mean immobility scores with NE3107 monotherapy (during weeks 8 and 9 on therapy) were significantly lower, indicating improved mobility, than comparison treatment with amantadine HCl or vehicle only.

Key Points: 
  • Results showed that mean immobility scores with NE3107 monotherapy (during weeks 8 and 9 on therapy) were significantly lower, indicating improved mobility, than comparison treatment with amantadine HCl or vehicle only.
  • Investigators concluded that the findings corroborate the involvement of chronic neuroinflammation and insulin resistance in PD clinical symptoms, in addition to neurodegenerative pathways, support the continued investigation of therapies like NE3107 nondopaminergic therapies.
  • In patients who received placebo + C/L, levodopa AUC was 3175.55 (±2526.68) ng·h/mL and 3093.19 (±1919.73) ng·h/mL on day 1 and day 14, respectively.
  • NE3107 +C/L-treated patients

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Amneal Pharmaceuticals, Inc. - AMRX

Retrieved on: 
Wednesday, July 19, 2023
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NEW YORK, July 19, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NYSE: AMRX).

Key Points: 
  • NEW YORK, July 19, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NYSE: AMRX).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Amneal and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Amneal Pharmaceuticals, Inc. - AMRX

Retrieved on: 
Sunday, July 9, 2023
CD, LLP, Amneal Pharmaceuticals, Symantec Endpoint Protection, NDA, Carbidopa, L-DOPA, CRL, FDA, Pomerantz, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, News, NYSE, Food, Safety

NEW YORK, July 09, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NYSE: AMRX).

Key Points: 
  • NEW YORK, July 09, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NYSE: AMRX).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Amneal and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

Amneal Receives U.S. FDA Complete Response Letter for IPX203

Retrieved on: 
Monday, July 3, 2023
FDA, Pharmaceutical, Health, Clinical Trials, CD, Amneal Pharmaceuticals, Symantec Endpoint Protection, NDA, Medication, Carbidopa, Patient, L-DOPA, CRL, Letter, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NYSE, Food, Safety, Pharmaceutical industry

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for IPX203 for the treatment of Parkinson’s disease.
  • The letter indicated that although an adequate scientific bridge was established for the safety of one ingredient, levodopa (LD), based on pharmacokinetic studies, it was not adequately established for the other ingredient, carbidopa (CD), and FDA has requested additional information.
  • The letter did not identify any issues with respect to the efficacy or manufacturing of IPX203.
  • Amneal will work closely with the FDA to address its comments and plans to meet with the agency to align on the best path forward.

Evecxia Therapeutics Announces Data Presentations on Lead Candidate EVX-101 at the 2023 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting

Retrieved on: 
Thursday, May 25, 2023
Mental Health, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Carbidopa, Doctor of Pharmacy, Drug, SAD, Doctor of Philosophy, Adjunct (grammar), Mental, DSM-IV codes, T30, MDD, Patient, Poster, Therapy, Pharmaceutical industry

Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat brain disorders, today announced that an oral presentation, “The Therapeutic Potential of EVX-101 to Amplify Serotonin Synthesis for the Adjunctive Treatment of MDD and Other Mental Illness: Emerging Profile and Post-Phase 1 Update”, will be presented during the Pharmaceutical Pipeline Session on May 30th by Dr. Jacobson, Chief Scientific Officer, at the 2023 ASCP Meeting in Miami Beach, FL.

Key Points: 
  • Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat brain disorders, today announced that an oral presentation, “The Therapeutic Potential of EVX-101 to Amplify Serotonin Synthesis for the Adjunctive Treatment of MDD and Other Mental Illness: Emerging Profile and Post-Phase 1 Update”, will be presented during the Pharmaceutical Pipeline Session on May 30th by Dr. Jacobson, Chief Scientific Officer, at the 2023 ASCP Meeting in Miami Beach, FL.
  • In addition, a poster (T30) presentation, “A Phase 1 SAD and MAD Trial of EVX-101, A Novel Gastro-Retentive Prolonged-Release 5-HTP/Low-Dose Carbidopa Tablet, in Healthy Subjects Taking Escitalopram” will be presented during Poster Session II from 12:30 pm – 2:15 pm on Thursday, June 1st by David Carpenter, PharmD, Executive Director, Clinical Development.
  • “We are excited to present the Phase 1 data on EVX-101 in combination with a first-line serotonin reuptake inhibitor in healthy volunteers.
  • The data support the use of EVX-101 as a first-choice therapy among next-line antidepressants and could provide a safe and efficacious option for MDD patients not responding to monotherapy with first-line serotonin reuptake inhibitors," remarked Jacob Jacobsen, PhD, Chief Scientific Officer of Evecxia Therapeutics.

Evecxia Therapeutics Receives Notice Of Allowance For A U.S. Patent Covering Its Lead Drug Candidate EVX‑101

Retrieved on: 
Friday, April 28, 2023
Alternative Medicine, Mental Health, Health, Neurology, Pharmaceutical, Biotechnology, Patent, DSM-IV codes, Excipient, 5-HTP, Serotonin, Therapy, Carbidopa, Patient, Safety, Pharmaceutical industry, Generic drug

Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat brain disorders, today announced that the U.S. Patent and Trademark Office has allowed U.S. patent application 17/877,699.

Key Points: 
  • Evecxia Therapeutics, Inc., the leader in serotonin synthesis amplification to treat brain disorders, today announced that the U.S. Patent and Trademark Office has allowed U.S. patent application 17/877,699.
  • The claims further cover specific physical characteristics, excipients, 5-HTP and carbidopa doses, in vitro dissolution profiles, and human in vivo pharmacokinetics profiles.
  • The allowed patent is a cornerstone in our portfolio of issued and pending patents covering EVX-101,” stated Jacob Jacobsen, Ph.D., Chief Scientific Officer of Evecxia.
  • The patent to be issued from U.S. patent application 17/877,699 is wholly owned by Evecxia Therapeutics and has a current expiry of 2042.

Evecxia Therapeutics Reports Favorable Data From a Phase 1 Single-Ascending Dose and Multiple-Ascending Dose Trial of Adjunctive EVX-101 in Healthy Volunteers Treated With a First-Line Antidepressant

Retrieved on: 
Monday, April 10, 2023
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Evecxia Therapeutics, Inc. today announced favorable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a double-blind, placebo-controlled Phase 1, a two-part single ascending dose (SAD) and multiple ascending dose (MAD) trial of EVX-101 in healthy volunteers treated with escitalopram.

Key Points: 
  • Evecxia Therapeutics, Inc. today announced favorable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a double-blind, placebo-controlled Phase 1, a two-part single ascending dose (SAD) and multiple ascending dose (MAD) trial of EVX-101 in healthy volunteers treated with escitalopram.
  • In EVX-101, the 5-HTP dose is fixed at 250 mg, while variable levels of carbidopa control 5-HTP plasma exposure levels.
  • Thirty-four healthy subjects were randomized to EVX-101 twice-daily (BID) or placebo in the Phase 1 SAD-MAD trial (EVX-101 N=25, Placebo N=9).
  • Best practices will be employed to ensure the quality and integrity of the EVX-101 Phase 2 trial.