Clinical Global Impression

Otsuka and Click Therapeutics Announce the U.S. Food and Drug Administration (FDA) Clearance of Rejoyn™, the First Prescription Digital Therapeutic Authorized for the Adjunctive Treatment of Major Depressive Disorder (MDD) Symptoms

Retrieved on: 
Monday, April 1, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Depression, Psychiatry, Brain, Mirai, Medication, MDD, Patient, DSM-IV codes, Therapy, Cognition, Regulation, Otsuka Pharmaceutical, MADRS, Multimedia, Clinical Global Impression, Emotion, Food, Pharmaceutical industry

Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.

Key Points: 
  • Unlike wellness apps, the Rejoyn app is a medical device authorized by the FDA for prescription by a healthcare professional.
  • “While traditional approaches are often effective, many are left with only a partial response to treatment.
  • “The clearance of Rejoyn signals a fundamental change in how clinicians can treat symptoms of major depressive disorder.
  • Rejoyn does not monitor the patient’s symptoms or clinical status and cannot send or receive alerts or warnings to the prescriber.

ORYZON Reports Financial Results and Corporate Update for Quarter Ended December 31, 2023

Retrieved on: 
Monday, February 26, 2024
Borderline personality disorder, HOPE, HDAC6, National Cancer Institute, EVOLUTION, CMT, Agitation, Data analysis, Convertible bond, ICIS, ALS, SCLC, Azacitidine, Duration, ICI, IIS, Sciatic nerve, Deficit spending, Paclitaxel, DSM-IV codes, Development, Genomics, ALS Association, FMS, LSD1, AML, Clinical Global Impression, MSKCC, Conference, Aggression, Safety, Biomarker, CNS, Venetoclax, CRADA, OHSU, MRD, Clinical trial, BPD, Measure (mathematics), IND, FCCC, Dor, Human, Innovation, EMA, Kabuki syndrome, NET, NCI, Aes, Glomus tumor, FDA, GST, Food, Platinum, Schizophrenia, Phase II, Charcot–Marie–Tooth disease, Medicine, Patient, BEST, Disease, Pharmaceutical industry

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the fourth quarter.
  • Research and development (R&D) expenses were $3.9 and $16.6 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $5.0 and $18.1 million for the quarter and twelve months ended December 31, 2022.
  • General and administrative expenses were $1.2 and $4.2 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.2 and $4.8 million for the quarter and twelve months ended December 31, 2022.
  • Net losses were $1.4 and $5.0 million for the quarter and twelve months ended December 31, 2023, respectively, compared to $1.6 and $5.9 million for the quarter and twelve months ended December 31, 2022.

Newron Reports Exceptional One-year Results of Study 014/15 With Evenamide in Treatment-resistant Schizophrenia (TRS)

Retrieved on: 
Thursday, January 4, 2024
Science, Biotechnology, Research, Pharmaceutical, Health, Mental Health, Clinical Trials, Other Health, Psychiatry, XETRA, ADOS, Medication, Positive, Incidence, Clinical Global Impression, CNS, Molecular medicine, PANSS, EKG, Weight gain, Longevity, Peripheral nervous system, TRS, Patient, Pharmaceutical industry

The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.

Key Points: 
  • The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.
  • In contrast to common clinical experience, no patient “relapsed” during the one-year treatment period.
  • Ravi Anand, Newron’s Chief Medical Officer, said: “Treatment with evenamide as an add-on to antipsychotics in TRS patients has produced benefits that have never been reported before.
  • The presentation for this conference call can be downloaded as of today, January 4, 2024, at 7 am CET, on Newron’s website ( https://www.newron.com/investors/reports-and-presentation/year/2024 ).

EQS-News: Newron reports exceptional one-year results of study 014/15 with evenamide in treatment-resistant schizophrenia (TRS)

Retrieved on: 
Thursday, January 4, 2024
Psychiatry, XETRA, ADOS, Positive, Incidence, Clinical Global Impression, CNS, Molecular medicine, PANSS, EKG, Weight gain, Longevity, Peripheral nervous system, TRS, Patient, Pharmaceutical industry

The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.

Key Points: 
  • The data demonstrated that treatment with evenamide was associated with sustained clinically significant benefit that increased throughout the one-year course of treatment.
  • In contrast to common clinical experience, no patient “relapsed” during the one-year treatment period.
  • 25% of all patients achieved “remission” (see “About remission”), never described before in TRS patients.
  • The presentation for this conference call can be downloaded as of today, January 4, 2024, at 7 am CET, on Newron’s website ( https://www.newron.com/investors/reports-and-presentation/year/2024 ).

Investigation Into Anavex Life Sciences Corp. (AVXL) Announced by Holzer & Holzer, LLC

Retrieved on: 
Wednesday, January 3, 2024
Fraud, News, Clinical Global Impression, ISS

ATLANTA, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Anavex Life Sciences Corp. (“Anavex” or the “Company”) (NASDAQ: AVXL) complied with federal securities laws.

Key Points: 
  • ATLANTA, Jan. 03, 2024 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Anavex Life Sciences Corp. (“Anavex” or the “Company”) (NASDAQ: AVXL) complied with federal securities laws.
  • If you purchased Anavex stock and suffered a loss on that investment, you are encouraged to contact Corey Holzer, Esq.
  • Since its founding in 2000, Holzer & Holzer attorneys have played critical roles in recovering hundreds of millions of dollars for shareholders victimized by fraud and other corporate misconduct.
  • Holzer & Holzer, LLC has paid for the dissemination of this promotional communication, and Corey Holzer is the attorney responsible for its content.

Anavex Life Sciences Provides an Update on Rett Syndrome Program

Retrieved on: 
Tuesday, January 2, 2024
DSM-IV codes, Lethargy, Șaeș, AVATAR, Rett syndrome, Caregiver, Microsoft Access, Research, Fragile X syndrome, Marketing, FDA, EMA, Data analysis, Disease, Somnolence, MD, Doctor of Philosophy, Clinical trial, Seizure, Orphan drug, Clinical Global Impression, European Medicines Agency, CHMP, Expanded access, Anxiety, Committee, Safety, Patient, Placebo, Real, RTT, Therapy, OLE, Fast Track, RWE, Pharmaceutical industry

NEW YORK, Jan. 02, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders today reported topline results from the randomized, double-blind, placebo-controlled, Phase 2/3 EXCELLENCE clinical trial, which evaluated the clinical efficacy, safety, and tolerability of 30 mg ANAVEX®2-73 in 92 pediatric patients with Rett syndrome (RTT) between the ages of 5 through 17 years. Participants were randomized 2:1 (ANAVEX®2-73 [62 patients] to placebo [30 patients]) for 12 weeks, followed by a week 16 safety visit. As well, Anavex reported positive Real World Evidence (RWE) feedback from Rett syndrome patients under Compassionate Use Authorization.

Key Points: 
  • As well, Anavex reported positive Real World Evidence (RWE) feedback from Rett syndrome patients under Compassionate Use Authorization.
  • After 12 weeks, the study showed improvement on the key co-primary endpoint Rett Syndrome Behaviour Questionnaire (RSBQ), which is a detailed 45-item questionnaire for assessing multiple Rett syndrome characteristics by the patients’ caregivers.
  • As of today, some patients with Rett syndrome have been on ANAVEX®2-73-treatment for over 4 years, combined OLE and Compassionate Use Program.
  • In addition to Rett syndrome, Anavex is evaluating ANAVEX®2-73 in other neurodevelopmental disorders, including Fragile X syndrome, and in neurodegenerative disorders like Parkinson’s disease.

Intra-Cellular Therapies Highlights Data Presentations at the American College of Neuropsychopharmacology Annual Meeting

Retrieved on: 
Tuesday, December 5, 2023
Neuropsychiatry, Treatment, DSM-IV codes, IND, Grammatical mood, Depression, Prevalence, Literature, Mouse, Human, DSM-5, Cyclothymia, MADRS, Anxiety, Prefrontal cortex, Hallucination, Annual general meeting, Clinical Global Impression, CNS, Social, Poster, American College, Restless, Central nervous system, MDD, Patient, Therapy, Lumateperone, Pharmaceutical industry

NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting.

Key Points: 
  • Company presents preclinical data on ITI-1549, our lead product candidate in our non-hallucinogenic psychedelics program in mood disorders and other psychiatric disorders.
  • NEW YORK, Dec. 05, 2023 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced data presentations at the American College of Neuropsychopharmacology (ACNP) 62nd Annual Meeting.
  • Inner tension is an item within the MADRS which is often used as a surrogate marker for anxiety.
  • The data presented in this poster represent further analyses from Study 403.

Xenon Pharmaceuticals Announces Topline Results from Phase 2 Proof-of-Concept X-NOVA Clinical Trial of XEN1101 in Major Depressive Disorder (MDD)

Retrieved on: 
Monday, November 27, 2023
Xenon, Șaeș, Physician, Anhedonia, Depression, Epilepsy, American Epilepsy Society, DSM-IV codes, Incidence, SAE, Seizure, Clinical Global Impression, Neurology, Weight gain, MDD, Patient, Safety, Pharmaceutical industry

The primary endpoint of the study was a change in the Montgomery-Åsberg Depression Rating Scale, or MADRS, at week 6.

Key Points: 
  • The primary endpoint of the study was a change in the Montgomery-Åsberg Depression Rating Scale, or MADRS, at week 6.
  • The mean reduction was 13.90 in the placebo group, 15.61 in the XEN1101 10 mg group and 16.94 in the XEN1101 20 mg group.
  • A clear dose response and a clinically meaningful, but not statistically significant, 3.04 difference between placebo and the XEN1101 20 mg group (p=0.135) was observed.
  • We are excited to share the data generated in X-NOVA with epileptologists and neurologists at the upcoming American Epilepsy Society meeting in December.”

e2e Pharma Realizes the Benefits of InstantGMP PRO™ All-In-One Software

Retrieved on: 
Wednesday, November 15, 2023
GMP, Education, SOP, Equipment, Good manufacturing practice, Beauty, Clinical Global Impression, CMOS, MPR, Health, Cosmetics, PRO, BPR, Software, CMO, Communication, Contract manufacturing organization, Good, Fine chemical, Medical device, Warehouse, Asset management, Risk management

CARY, N.C., Nov. 15, 2023 /PRNewswire-PRWeb/ -- InstantGMP™, the industry frontrunner in electronic batch record, quality management, and inventory management software solutions, proudly commemorates two years of support to e2e Pharma, a distinguished Arizona-based Contract Manufacturing Organization (CMO).

Key Points: 
  • A leader in white-label and private-label contract manufacturing across diverse industries, including health, wellness, beauty, cosmetics, and pet products, e2e Pharma continues to benefit immensely from the innovative InstantGMP PRO™ software system.
  • With InstantGMP PRO, e2e Pharma and similar CMOs can improve their manufacturing processes and overall customer experience.
  • Key Benefits of InstantGMP PRO for e2e Pharma and Similar CMOs:
    Streamlined MPR, BPR, and SOP Creation: InstantGMP PRO simplifies the creation of Master Production Records (MPR), Batch Production Records (BPR), and Standard Operating Procedures (SOP).
  • InstantGMP takes immense pride in supporting e2e Pharma's operational excellence by implementing our all-in-one manufacturing, inventory, and quality system.

Inozyme Pharma Reports Third Quarter 2023 Financial Results and Provides Business Highlights

Retrieved on: 
Tuesday, November 7, 2023
Generalized arterial calcification of infancy, Patient, Research, Research and development, Genomics, Clinical trial, PD, Calciphylaxis, Therapy, Biomarker, ESKD, G&A, American Society of Nephrology, Conference, Pros, Kidney disease, R, American Society for Bone and Mineral Research, Society, PXE, Columbia University School of General Studies, ENPP1, ASN, PK, Clinical Global Impression, Annual general meeting, GIC, Safety, ABCC6, Investment, Doctor of Philosophy, Administration, Nursing, Pharmaceutical industry

BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY) (“Inozyme” or the “Company”), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today reported financial results for the third quarter ended September 30, 2023 and provided business highlights.

Key Points: 
  • Patient recruitment is underway, and the Company remains on track to report topline data in mid-2025.
  • Exploratory efficacy data reported suggested clinical benefit for ENPP1 Deficiency, including improvement in key biomarkers, patient-reported outcomes (PROs), and functional outcomes.
  • R&D Expenses were $13.3 million for the quarter ended September 30, 2023, compared to $12.2 million for the prior-year period.
  • Net loss was $16.6 million, or $0.29 loss per share, for the quarter ended September 30, 2023, compared to $16.4 million, or $0.38 loss per share, for the prior-year period.