Medsafe

Optimi Health Signs Psilocybin Supply Agreement With New Zealand-Based Mātai Medical Research Institute

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Martedì, Aprile 9, 2024
Psilocybin, First Nations, Wharerātā, Certificate, Patient, Ethics, FRA, COA, Synthetic, Health Canada, Trial of the century, GMP, Clinical trial, Ground substance, Safety, MDMA, Medsafe, Medicine, Pharmaceutical industry

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is proud to announce the signing of an international natural psilocybin supply agreement with New Zealand-Based Mātai Medical Research Institute (Mātai), on behalf of the Tū Wairua Project.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN), a leading Health Canada licensed psychedelics pharmaceutical manufacturer, specializing in controlled substances such as natural psilocybin and MDMA, is proud to announce the signing of an international natural psilocybin supply agreement with New Zealand-Based Mātai Medical Research Institute (Mātai), on behalf of the Tū Wairua Project.
  • This agreement marks Optimi's first supply deal to New Zealand, a significant milestone for the company's global expansion efforts.
  • Under the terms of the agreement, Optimi will provide Mātai with a quantity of its validated GMP Full Spectrum Natural Psilocybin extract.
  • Further, the agreement includes tracked stability of the extract, ensuring the highest standards of GMP quality and compliance.

Verve Therapeutics Announces Updates on its PCSK9 Program

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Martedì, Aprile 2, 2024
LDLR, Cardiovascular disease, Gene editing, PCSK9, ALT, Patient, RNA, Health care, Health Canada, IND, N-Acetylgalactosamine, MHRA, Asialoglycoprotein receptor, Clinical trial, CTAS, Therapy, Bleeding, Safety, Moyamoya disease, DSMB, FDA, Liver, ASCVD, LNP, Medsafe, Hypercholesterolemia, Food, Pharmaceutical industry

BOSTON, April 02, 2024 (GLOBE NEWSWIRE) -- Verve Therapeutics, a clinical-stage biotechnology company pioneering a new approach to the care of cardiovascular disease with single-course gene editing medicines, today announced updates from the Heart-1 Phase 1b clinical trial of VERVE-101 and clearance of its Clinical Trial Applications (CTAs) by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and Health Canada for VERVE-102, with the Heart-2 Phase 1b clinical trial expected to initiate in the second quarter of this year.

Key Points: 
  • Six participants have been dosed at 0.45 mg/kg of VERVE-101, with a total of 13 participants dosed in the study.
  • Verve is conducting an investigation into the laboratory abnormalities and based on those results, expects to work with regulatory authorities to define a path forward for VERVE-101.
  • Verve is now prioritizing the development of VERVE-102 and the initiation of the Heart-2 clinical trial.
  • VERVE-102 uses the same base editor and guide RNA for PCSK9 but a different lipid nanoparticle (LNP) delivery system than VERVE-101.

Protalix BioTherapeutics Reports Second Quarter 2023 Financial and Business Results

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Lunedì, Agosto 7, 2023
Protalix BioTherapeutics, Medsafe, European Medicines Agency, Tax, MD, Patient, European, Fabry disease, BLA, NYSE, Calendar, Gout, Half-life, Pharmacokinetics, Research, EMA, Russell, FIH, Growth, FDA, PEGylation, Biologics license application, Safety, Civil service commission, Health, Baylor University Medical Center, Israel Innovation Authority, FASN, Webcast, MAA, HDEC, European Commission, KOL, Clinical trial, EDT, Marketing, ERT, EC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Vaccine, Pharmaceutical industry, Drug, Life insurance, Online shopping, EU, Fabry, Chiesi Farmaceutici

CARMIEL, Israel, Aug. 7, 2023 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the second quarter ended June 30, 2023 and provided a business update on recent regulatory, clinical and corporate developments.

Key Points: 
  • "2023 has been a transformational year for Protalix thus far," said Dror Bashan, Protalix's President and Chief Executive Officer.
  • On May 5, 2023, the European Commission (EC) granted marketing authorization to Elfabrio (pegunigalsidase alfa) in the European Union.
  • On June 26, 2023, the Company was included in the broad-market Russell 3000® Index at the conclusion of the 2023 Russell indexes annual reconstitution.
  • Financial expenses, net were $0.8 million for the three months ended June 30, 2023, compared to financial income, net of $0.2 million for the three months ended June 30, 2022.

Arbutus Reports Second Quarter 2023 Financial Results and Corporate Update

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Giovedì, Agosto 3, 2023
EASL, Arm, Drug development, Therapy, General counsel, Virology, NA, Clinical trial, Drug, Immunity, CTA, Viral, Roivant Sciences, Research, CFBV, RNA, Doctor of Philosophy, Arbutus, Congress, Medsafe, HBsAg, Investigational New Drug, Patent, MD, Patient, Investment, Immune system, Chief medical informatics officer, RNA interference, European Association for the Study of the Liver, PD-1, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, HBV, Food, Safety, Nivolumab, Pharmaceutical industry, Vaccine, Tutoring, Liver

We plan to provide a further update on this clinical trial when we have additional meaningful patient data.

Key Points: 
  • We plan to provide a further update on this clinical trial when we have additional meaningful patient data.
  • Preliminary data from patients in the clinical trial are expected in the second half of 2023.
  • The Phase 1 clinical trial with AB-161 is on-going with single-ascending dose data expected in the second half of 2023.
  • We expect to nominate an nsp12 inhibitor clinical candidate and initiate IND-enabling studies in the second half of 2023.

AVM Biotechnology Announces Twenty-Eight (28) Solid Tumor and Blood Cancer Patients have been Treated with Immunomodulatory AVM0703 through Expanded Access/Compassionate Use Programs

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Martedì, Agosto 1, 2023
Oncology, Health, Consumer, Seniors, Clinical Trials, Pharmaceutical, Biotechnology, NIDDK, Marketing, Pain, Medsafe, Adoptive cell transfer, Patient, Carcinoma, Leukemia, Prostate cancer, Disease, Human, EAP, DLBCL, SBIR, Expanded access, Physician, Bone marrow, Research, Lung cancer, Glioblastoma, CUP, Cancer, Type 1, FDA, NCI, Safety, NOD, Desmoplastic small-round-cell tumor, Multimedia, Medicine, CAR, National Cancer Institute, Animal, B-ALL, Otorhinolaryngology, Drug development, Clinical trial, NHL, National Institutes of Health, Medication, CNS, Sale, AVM, American Cancer Society, Nursing, Vaccine, Pharmaceutical industry, Medical device, TCR

Requests for additional information about immunomodulatory AVM0703 and its relatively broad activity against solid tumors and blood cancers can be made by contacting [email protected] .

Key Points: 
  • Requests for additional information about immunomodulatory AVM0703 and its relatively broad activity against solid tumors and blood cancers can be made by contacting [email protected] .
  • “AVM Biotechnology is committed to providing AVM0703 to patients who cannot participate in our enrolling clinical trial.
  • Our team at AVM Biotechnology is dedicated to providing hope to patients and their loved ones.” Theresa Deisher, AVM Biotechnology , Founder and CEO.
  • AVM Biotechnology is a clinical stage company headquartered in Seattle, WA developing immunomodulatory therapies for hematological cancer, infectious and autoimmune diseases.

The Global Antipsychotic Drugs Market to Register Growth at a CAGR of ~7% by 2027 | DelveInsight

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Giovedì, Febbraio 2, 2023
Pharmacy, Personality disorder, Pfizer, PTSD, Schizoaffective disorder, Safety, Sun Pharma, Lundbeck, Ethics, Cariprazine, Statistics, Anxiety, Alvogen, Bristol Myers Squibb, HDEC, Mental disorder, Bipolar I disorder, Disorder, Depression, Post-traumatic stress disorder, Food, Hallucination, DSM-IV codes, Zydus Lifesciences, Prevalence, USFDA, US Foods, LAS, Mental health, GSK, Laboratory, Government, MDMA, Thought, Addiction, USP, Schizophrenia, Sale, Bipolar disorder, Research, Agonist, Silvio Pettirossi International Airport, COVID-19, Bayer, GSK plc, Cardinal Health, World Health Organization, Drug development, Mania, WHO, Viatris, Conduct disorder, AbbVie, Delusion, Pharmaceutical industry, Medsafe

LAS VEGAS, Feb. 2, 2023 /PRNewswire/ -- DelveInsight's Antipsychotic Drugs Market Insights report provides the current and forecast market analysis, individual leading antipsychotic drugs companies' market shares, challenges, antipsychotic drugs market drivers, barriers, and trends, and key antipsychotic drugs companies in the market.

Key Points: 
  • LAS VEGAS, Feb. 2, 2023 /PRNewswire/ -- DelveInsight's Antipsychotic Drugs Market Insights report provides the current and forecast market analysis, individual leading antipsychotic drugs companies' market shares, challenges, antipsychotic drugs market drivers, barriers, and trends, and key antipsychotic drugs companies in the market.
  • As per DelveInsight estimates, North America is anticipated to dominate the global antipsychotic drugs market during the forecast period.
  • Furthermore, increased awareness resulted in increased adoption of these drugs in key countries, significantly increasing antipsychotic drugs market growth in key countries.
  • However, the high cost of drug development and launch, addiction caused by antipsychotic drugs, and the stringent regulatory approval process may stall the antipsychotic drugs market growth.

Amarin Announces VAZKEPA® (Icosapent Ethyl) Approved By Medsafe In New Zealand

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Venerdì, Gennaio 27, 2023
Research and development, Cardiovascular disease, Medsafe, Risk, Professional corporation, EVP, Patient, Amarin Corporation, Death, Pharmaceutical industry

DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 27, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that Medsafe in New Zealand has granted approval to VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in adult statin-treated patients with high CV risk with elevated triglycerides.

Key Points: 
  • DUBLIN, Ireland and BRIDGEWATER, N.J., Jan. 27, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced that Medsafe in New Zealand has granted approval to VAZKEPA (icosapent ethyl) to reduce the risk of cardiovascular (CV) events in adult statin-treated patients with high CV risk with elevated triglycerides.
  • Cardiovascular disease is a significant health issue for people living in New Zealand.
  • Currently, an estimated 175,000 adult New Zealanders are living with cardiovascular disease, and one in three deaths in New Zealand are caused by cardiovascular disease.i
    “The regulatory approval of VAZKEPA in New Zealand adds to the ongoing progress by Amarin to bring an important treatment to patients to help address their residual cardiovascular disease risk,” said Steven Ketchum, EVP & President, Research & Development, Amarin.
  • Amarin is now actively engaging with potential commercialization partners in New Zealand to support the introduction of VAZKEPA across the New Zealand market.

atai Life Sciences Announces Initiation of Phase 1 Trial for its MDMA Derivative, EMP-01

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Martedì, Settembre 27, 2022
Adult, Selective serotonin reuptake inhibitor, Therapy, PK, Safety, Amphetamine, Ethics, COVID-19, Infection, Brain, FDA, Addiction, Paroxetine, NEW, Norepinephrine, Senior, Intellectual property, MDMA, Private Securities Litigation Reform Act, HDEC, Hypertension, Stroke, Forward-looking statement, U.S. Securities and Exchange Commission, Public expenditure, Patient, Mental health, List of life sciences, CEO, Dopamine, Therapeutic index, Annual report, Nasdaq, Serotonin, Anxiety, Diagnosis, Cardiovascular disease, Pharmacology, Foundation for the National Institutes of Health, Research, Security (finance), GLOBE, Post-traumatic stress disorder, SEC, National Institute, Sertraline, PTSD, Failure, Depression, Pharmaceutical industry, Medsafe, Health

NEW YORK and BERLIN, Sept. 27, 2022 (GLOBE NEWSWIRE) -- atai Life Sciences N.V. (Nasdaq: ATAI) (“atai”), which is developing EMP-01, a 3,4-methylenedioxy-methamphetamine (MDMA) derivative for the treatment of post-traumatic stress disorder (PTSD) and other indications, announced today its Phase 1 study has received regulatory and ethics approvals required from Medsafe and HDEC, respectively, to initiate participant enrollment.

Key Points: 
  • Evidence shows that two-thirds of patients either do not respond or have only a partial response to these medications.
  • These modifications are designed to separate the entactogenic effects of MDMA from some of the known side effects, specifically its stimulant-associated effects.
  • Data on MDMA-assisted psychotherapy strongly suggests its potential for the treatment of PTSD, said Glenn Short, Senior Vice President, Early Development of atai Life Sciences.
  • atai Life Sciences is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders.

Sharps Compliance To Be Acquired By an Affiliate of Aurora Capital Partners

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Martedì, Luglio 12, 2022
Security (finance), Personal Information Agent, Schedule, U.S. Securities and Exchange Commission, Annual report, Letter, TIME, Substance-related disorder, Medsafe, AND, EACH, SEC, News, Company, Schedule TO, Offer and acceptance, GLOBE, Risk, Suite, Calendar, Partnership, Coronavirus, COMMON, LLP, Solution, Waste, COVID-19, Phrase, WILL, Compliance, Growth, HSR, Industry, Long-term care, NASDAQ, SMED, Hazardous waste, Hart–Scott–Rodino Antitrust Improvements Act, Board, Sumathi Best Television Current Reporting Award, THE, Risk management

Pat Mulloy, President and Chief Executive Officer of Sharps, stated, Sharps is a leading provider of comprehensive solutions for the small to medium generators of medical, hazardous and pharmaceutical waste.

Key Points: 
  • Pat Mulloy, President and Chief Executive Officer of Sharps, stated, Sharps is a leading provider of comprehensive solutions for the small to medium generators of medical, hazardous and pharmaceutical waste.
  • Raymond James & Associates, Inc. acted as financial advisor and Norton Rose Fulbright US LLP acted as legal advisor to Sharps.
  • Headquartered in Houston, Texas, Sharps Compliance (NASDAQ: SMED) is a leading business-to-business services provider to the healthcare, long-term care and retail pharmacy markets.
  • Sharps Compliance offers comprehensive solutions for the management of regulated medical waste, hazardous waste and unused medications.

Sharps Compliance Partners with PharMerica Corporation to Bring MedSafe to Long-Term Care Facilities

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Lunedì, Gennaio 24, 2022
Prescription, Compliance, Nursing, Patient, News, Medsafe, PharMerica, Substance-related disorder, LTC, Hazardous waste, COVID-19, Pharmacy, Population, Partnership, Safety, Collection, GLOBE, Solution, Government, DEA, Sharps, Waste, U.S. Securities and Exchange Commission, Long-term care, SMED, Nasdaq, Dentist, Phrase, Company, Method, MHA, Cancer, EPA, Security (finance), Hospital, Coronavirus, Senior, Transport, Physician, Risk, Annual report, Health insurance, Risk management

In addition to unused medication management, the MedSafe is designed to reduce cost to LTC facilities through effective and efficient collection, transportation and treatment.

Key Points: 
  • In addition to unused medication management, the MedSafe is designed to reduce cost to LTC facilities through effective and efficient collection, transportation and treatment.
  • Sharps Compliance and PharMerica are now partnering to expand the use of MedSafe in LTC communities.
  • Additionally, by utilizing the MedSafe, LTC facilities can reduce operating costs when compared to traditional methods of medication disposal.
  • It combines industry-leading secure receptacles with the reverse distribution, destruction, and reporting capabilities of Sharps Compliance via a patented inner liner system.