Food and Drug Administration Amendments Act of 2007

Arch Therapeutics Provides Year End Operational Update

Retrieved on: 
Thursday, November 9, 2023
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FRAMINGHAM, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical products, today provided a year-end operational update, including key performance metrics related to the ongoing commercialization activities for the Company’s first product, AC5® Advanced Wound System (“AC5”).

Key Points: 
  • FRAMINGHAM, Mass., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), a marketer and developer of novel self-assembling wound care and biosurgical products, today provided a year-end operational update, including key performance metrics related to the ongoing commercialization activities for the Company’s first product, AC5® Advanced Wound System (“AC5”).
  • A more detailed summary of key milestones and achievements from the fiscal year ended September 30, 2023 is provided below.
  • At SAWC Spring 2023, Arch introduced the theme “Experience the Difference” to highlight AC5’s technology, application, wound coverage, and efficacy.
  • AC5 is a synthetic self-assembling wound care product that provides clinicians with multi-modal support and utility across all phases of wound healing.

BRAINSTORM CELL ALERT: Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Brainstorm Cell Therapeutics Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, November 9, 2023
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NEW YORK, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI) in the United States District Court for the Southern District of New York on behalf of all persons and entities who purchased or otherwise acquired Brainstorm Cell securities between August 15, 2022 and September 27, 2023, both dates inclusive (the “Class Period”).

Key Points: 
  • NEW YORK, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI) in the United States District Court for the Southern District of New York on behalf of all persons and entities who purchased or otherwise acquired Brainstorm Cell securities between August 15, 2022 and September 27, 2023, both dates inclusive (the “Class Period”).
  • Investors have until January 2, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Click here to participate in the action.
  • There is no cost or obligation to you.

Ketamine can rapidly reduce symptoms of PTSD and depression, new study finds

Retrieved on: 
Wednesday, November 8, 2023
Post-traumatic stress disorder, Patient, Ketamine, Suicide, Grammatical mood, Research, Survivor, Time, Food, Nightmare, Child abuse, Sertraline, Annals of Pharmacotherapy, Injection, Psychotherapy, Veteran, Trauma, Meta-analysis, PTSD, Disorder, Disease, Assault, LSD, Pharmacy, Population, Paroxetine, Depression, Anxiety, Food and Drug Administration Amendments Act of 2007, Pharmaceutical industry, Vaccine, Meat

The drug ketamine can reduce the symptoms of post-traumatic stress disorder, or PTSD, and symptoms of depression in patients as early as a day after injection.

Key Points: 
  • The drug ketamine can reduce the symptoms of post-traumatic stress disorder, or PTSD, and symptoms of depression in patients as early as a day after injection.
  • Patients receiving ketamine saw their PTSD symptoms reduced by about 25% both at one day and one week after therapy.
  • Ketamine might be an effective bridge to immediately reduce patients’ symptoms until trauma-focused psychotherapy and other antidepressants can kick in.
  • What still isn’t known
    The big unknown with using ketamine for PTSD and depressive symptoms is how often the injections are needed.

Nuvectis Pharma, Inc. Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Wednesday, November 8, 2023
Neoplasm, Research, Cancer, Food, Exercise, Disease, Platinum, Investment, Food and Drug Administration Amendments Act of 2007, Pharmaceutical industry, Cryptocurrency, Patient, Cholangiocarcinoma

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "In the third quarter we continued to advance the development programs of NXP800 and NXP900.

Key Points: 
  • Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "In the third quarter we continued to advance the development programs of NXP800 and NXP900.
  • Cash, cash equivalents, and short-term investments were $22.1 million as of September 30, 2023, compared to $20.0 million as of December 31, 2022.
  • The Company's net loss was $5.9 million for the three months ended September 30, 2023, compared to $5.9 million for the three months ended September 30, 2022.
  • General and administrative expenses were $1.7 million for the three months ended September 30, 2023, compared to $1.4 million for the three months ended September 30, 2022.

Corbus Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023
Rimonabant, NSCLC, Food, Biomarker, Doctor of Philosophy, CB1, Breast cancer, University of Virginia Cancer Center, SITC, The Obesity Society, Head, CSPC, FACP, Human, Therapeutic index, Cleavage, Yale School of Medicine, Society for Immunotherapy of Cancer, Mouse, DIO, Immunotherapy, University, Hand, Investment, Patient, Monoclonal antibody, Food and Drug Administration Amendments Act of 2007, Plasma, Conference, Liraglutide, Development, ADC, Brain, Insulin resistance, Society, AACR, IND, Manuscript, Poster, MMAE, Semaglutide, Tumor microenvironment, Carcinoma, Mab, Neck, Medical imaging, Vaccine, Soft drink, Pharmaceutical industry, Corbus, MD, Obesity

“The third quarter was a productive period for Corbus as data was presented for each of our three programs at relevant scientific conferences” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.

Key Points: 
  • “The third quarter was a productive period for Corbus as data was presented for each of our three programs at relevant scientific conferences” said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.
  • Finally, we presented the first ever comprehensive data on CRB-913, our highly peripherally restricted cannabinoid type-1 receptor (CB1) inverse agonist.
  • Early clinical experience will be shared in Q1 2024, which will coincide with the initiation of a U.S./EU trial by Corbus.
  • Corbus presented two posters at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) held on November 1 - 5, 2023.

uniQure Announces Third Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Tuesday, November 7, 2023
Temporal lobe epilepsy, FDA, CSL, Research, Sale, IND, SOD1, Food, Chief scientific officer, ALS, Fabry disease, Workforce, Acquisition, Phase, Neuroscience, Hand, Nobel Prize, Safety, ARD International Music Competition, Investment, France, Patient, Immunosuppression, Food and Drug Administration Amendments Act of 2007, Pharmaceutical industry, Management, Cryptocurrency, EU

and AMSTERDAM, Nov. 07, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the third quarter of 2023 and highlighted recent progress across its business.

Key Points: 
  • and AMSTERDAM, Nov. 07, 2023 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today reported its financial results for the third quarter of 2023 and highlighted recent progress across its business.
  • Screening and patient enrollment is expected to begin in the fourth quarter of 2023 with first patient dosing planned to occur in the first quarter of 2024.
  • The Company expects to initiate patient screening in the fourth quarter of 2023 with first patient dosing planned to occur in the first quarter of 2024.
  • AMT-191 for the treatment of Fabry disease – The Company expects to submit an IND in the fourth quarter of 2023 and to begin patient dosing in 2024.

Arch Therapeutics to Present AC5® Advanced Wound System at the 2023 Symposium on Advanced Wound Care Fall Meeting (SAWC Fall)

Retrieved on: 
Thursday, November 2, 2023
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FRAMINGHAM, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), developer of novel self-assembling wound care and biosurgical devices, today announced that the Company’s first commercial product, AC5® Advanced Wound System (“AC5”), will be featured at the 2023 Symposium on Advanced Wound Care Fall Meeting (“SAWC Fall”), which takes place at Caesars Palace, Las Vegas, from November 2-5, 2023.

Key Points: 
  • FRAMINGHAM, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”), developer of novel self-assembling wound care and biosurgical devices, today announced that the Company’s first commercial product, AC5® Advanced Wound System (“AC5”), will be featured at the 2023 Symposium on Advanced Wound Care Fall Meeting (“SAWC Fall”), which takes place at Caesars Palace, Las Vegas, from November 2-5, 2023.
  • On Sunday, November 5, 2023 from 9:10 A.M. EST – 11:20 A.M. EST, AC5 will be featured in the Advanced Wound Care Therapy for the Lower Extremity: Hands-On Skills Lab.
  • Terrence W. Norchi, MD, President and CEO of Arch Therapeutics said, “SAWC presents an important opportunity to showcase our proprietary self-assembling peptide technology to wound care providers.
  • AC5 is a synthetic self-assembling wound care product that provides clinicians with multi-modal support and utility across all phases of wound healing.

JAMA Neurology Publishes Complete Results of Positive Phase 3 Study of REXULTI® (brexpiprazole) for Agitation Associated with Dementia Due to Alzheimer’s Disease

Retrieved on: 
Monday, November 6, 2023
Research, Mental Health, Neurology, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Behavioral neuroscience, Attention, Headache, Incidence, CMAI, Food, Mini–Mental State Examination, DSM-IV codes, Brexpiprazole, OPDC, MD, Psychiatry, Food and Drug Administration Amendments Act of 2007, Deficit spending, Verbal aggression, Dementia, Multimedia, Medicine, Interview, Pneumonia, Somnolence, Lundbeck, Locomotion, Commercialization, JAMA Neurology, Cachexia, Screaming, Caregiver, Passive-aggressive behavior, Aggression, Saint Louis University School of Medicine, MMSE, Heart, Ōtsuka, Akathisia, Contra body movement, Agitation, Medication, Tearing, Anxiety, IPA, Patient, Diagnosis, Disease, Restless, Pharmaceutical industry, Nursing, Birth control

REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.

Key Points: 
  • REXULTI is not indicated as an as needed (“prn”) treatment for agitation associated with dementia due to Alzheimer’s disease.
  • Participants also required a diagnosis that met The International Psychogeriatric Association’s (IPA) provisional definition of agitation in patients with cognitive impairment or dementia.
  • “Agitation associated with dementia due to Alzheimer’s disease can be very challenging and emotionally distressing for patients and family members caring for them.
  • The trial had high rates of patients completing the trial: 86.8% of the brexpiprazole group and 88.9% of the placebo group.

BRAINSTORM CELL ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against Brainstorm Cell Therapeutics Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, November 4, 2023
Class Action Lawsuit, Professional Services, Legal, FDA, Food, Person, Telephone, Court, Food and Drug Administration Amendments Act of 2007, P.C, Jeanne Eagels, District court, BLA, Pharmaceutical industry

Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI) in the United States District Court for the Southern District of New York on behalf of all persons and entities who purchased or otherwise acquired Brainstorm Cell securities between August 15, 2022 and September 27, 2023, both dates inclusive (the “Class Period”).

Key Points: 
  • Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, announces that a class action lawsuit has been filed against Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI) in the United States District Court for the Southern District of New York on behalf of all persons and entities who purchased or otherwise acquired Brainstorm Cell securities between August 15, 2022 and September 27, 2023, both dates inclusive (the “Class Period”).
  • Investors have until January 2, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • Click here to participate in the action.
  • There is no cost or obligation to you.

PharmaCyte Biotech Provides Corporate Update on Cell-in-a-Box Technology

Retrieved on: 
Tuesday, October 31, 2023
Research, FDA, Diabetes, Health Technology, Biotechnology, Health, Pharmaceutical, Science, Oncology, University, Survival, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Microbiology, PMCB, Cell, Medicine, Partnership, Effectiveness, Pancreatic cancer, Patient, Toxicity, Food and Drug Administration Amendments Act of 2007, Pharmaceutical industry

PharmaCyte Biotech, Inc. (Nasdaq: PMCB) (“PharmaCyte” or the “Company”) provides an update on its investigation of its Cell-in-a-Box technology and initial next steps in development.

Key Points: 
  • PharmaCyte Biotech, Inc. (Nasdaq: PMCB) (“PharmaCyte” or the “Company”) provides an update on its investigation of its Cell-in-a-Box technology and initial next steps in development.
  • Following a comprehensive scientific review of amassed data, the Company is in the process of requesting a meeting with the U.S. Food and Drug Administration (FDA) for guidance on further development of the technology.
  • The meeting is expected to occur during the first quarter of 2024.
  • PharmaCyte’s Board member, Professor of Surgery and Microbiology and Dean, College of Medicine – Tucson at the University of Arizona, Dr. Michael M.I.