Medication

Enanta Pharmaceuticals Doses First Subject in a Phase 1 Clinical Study of EDP-323, its Novel, Oral L-Protein Inhibitor in Development for the Treatment Respiratory Syncytial Virus

Retrieved on: 
Monday, October 17, 2022
Research, Infectious Diseases, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Degenerative disease, Institute of Liver and Biliary Sciences, Lung, Securities and Exchange Commission (Philippines), Human, AbbVie, MAD, Pneumonia, Infection, Cytokine, Glecaprevir/pibrentasvir, Severe acute respiratory syndrome coronavirus 2, NASDAQ, Research, Security (finance), Epithelium, Respiratory syncytial virus, Inflammation, Risk, Senior, Center, Hepatitis B virus, Drug discovery, Industry, Immunodeficiency, Pharmacokinetics, United, Patent, Safety, Bronchiolitis, SAD, Medication, HBV, Korea Disease Control and Prevention Agency, Plasma, FE, Viral load, Death, COVID-19, Pathology, HCV, Leadership, Pharmaceutical industry, Vaccine, RSV

EDP-323 could be used as a monotherapy or in combination with other RSV mechanisms, such as EDP-938, to broaden the addressable patient populations or treatment windows.

Key Points: 
  • EDP-323 could be used as a monotherapy or in combination with other RSV mechanisms, such as EDP-938, to broaden the addressable patient populations or treatment windows.
  • Additionally, EDP-323 has favorable oral bioavailability with good plasma exposures across preclinical species and pharmacokinetic properties supporting once-daily oral dosing in humans.
  • Enantas research and development programs include clinical candidates currently in development for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV).
  • Enantas research and development activities are funded by royalties from hepatitis C virus (HCV) products developed under its collaboration with AbbVie.

Ferring Introduces Fertility Outreach, a Text-based Platform Providing Aspiring Parents with Access to a Live Fertility Coach

Retrieved on: 
Tuesday, October 18, 2022
LinkedIn, Insurance, Medicine, Woman, Diagnosis, YouTube, Maternal health, United States Public Health Service, Parent, Reproductive medicine, Mother, Patient, Depression, Gastroenterology, Research, Twitter, Instagram, MPH, Mental health, Partnership, Cancer, Cardiff University, Press release, CEO, Ecosystem, Ferring Pharmaceuticals, Fertility, Medication, Infertility, Anxiety, Birth control, Tutoring, Facebook, MD, Ferring

Through Fertility Outreach, Ferring aims to address the very real and sometimes overlooked aspects of a fertility journey that aspiring parents experience and may need additional support navigating.

Key Points: 
  • Through Fertility Outreach, Ferring aims to address the very real and sometimes overlooked aspects of a fertility journey that aspiring parents experience and may need additional support navigating.
  • With Fertility Outreach, aspiring parents are now just a text message away to connecting with expert coaches to receive personalized and empowering guidance and information."
  • Fertility Outreach is part of Fertility Out Loud, a platform and social community that Ferring launched in 2021 to help improve access to care for all aspiring parents.
  • Robyn is a community-driven digital platform that provides access to a network of integrative parental wellness tools, resources, and specialists.

PRODUCTLIFE GROUP ANNOUNCES ACQUISITION OF ZWIERS REGULATORY CONSULTANCY AND COVERAGE EXPANSION TO THE NETHERLANDS

Retrieved on: 
Tuesday, October 18, 2022
PLG, European Medicines Agency, Pharma, Medtech, Therapy, Efficiency, Organon, EMA, Patient, Drug development, Partnership, Pharmacovigilance, Oss, Acquisition, Industry, Health, Medication, CEO, Leadership, Creativity, Compliance, Pharmaceutical industry, Medical device, Merck, EU, Biotechnology

PARIS, Oct. 18, 2022 /PRNewswire/ -- ProductLife Group (PLG), the global provider of regulatory, vigilance and quality services for the Pharmaceutical, Medtech and Biotech industries announces the acquisition of Zwiers Regulatory Consultancy - a consultancy specialising in regulatory affairs, pharmacovigilance and integrated development for drugs and devices with offices in Amsterdam and Oss, the Netherlands.

Key Points: 
  • PARIS, Oct. 18, 2022 /PRNewswire/ --ProductLife Group (PLG), the global provider of regulatory, vigilance and quality services for the Pharmaceutical, Medtech and Biotech industries announces the acquisition of Zwiers Regulatory Consultancy - a consultancy specialising in regulatory affairs, pharmacovigilance and integrated development for drugs and devices with offices in Amsterdam and Oss, the Netherlands.
  • Since 2011, Zwiers Regulatory Consultancy has established a reputation as a strategic partner in the life sciences industry.
  • Through this acquisition, PLG immediately expands and substantially enhances its comprehensive suite of drug development services and medical device expertise.
  • ProductLife Group's mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions.

PRODUCTLIFE GROUP ANNOUNCES ACQUISITION OF ZWIERS REGULATORY CONSULTANCY AND COVERAGE EXPANSION TO THE NETHERLANDS

Retrieved on: 
Tuesday, October 18, 2022
PLG, European Medicines Agency, Pharma, Medtech, Therapy, Efficiency, Organon, EMA, Patient, Drug development, Partnership, Pharmacovigilance, Oss, Acquisition, Industry, Health, Medication, CEO, Leadership, Creativity, Compliance, Pharmaceutical industry, Medical device, Merck, EU, Biotechnology

PARIS, Oct. 18, 2022 /PRNewswire/ -- ProductLife Group (PLG), the global provider of regulatory, vigilance and quality services for the Pharmaceutical, Medtech and Biotech industries announces the acquisition of Zwiers Regulatory Consultancy - a consultancy specialising in regulatory affairs, pharmacovigilance and integrated development for drugs and devices with offices in Amsterdam and Oss, the Netherlands.

Key Points: 
  • PARIS, Oct. 18, 2022 /PRNewswire/ --ProductLife Group (PLG), the global provider of regulatory, vigilance and quality services for the Pharmaceutical, Medtech and Biotech industries announces the acquisition of Zwiers Regulatory Consultancy - a consultancy specialising in regulatory affairs, pharmacovigilance and integrated development for drugs and devices with offices in Amsterdam and Oss, the Netherlands.
  • Since 2011, Zwiers Regulatory Consultancy has established a reputation as a strategic partner in the life sciences industry.
  • Through this acquisition, PLG immediately expands and substantially enhances its comprehensive suite of drug development services and medical device expertise.
  • ProductLife Group's mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions.

ISPE Provides Guidance on Improving and Advancing Process Performance and Product Quality Monitoring Systems

Retrieved on: 
Monday, October 17, 2022
Maturity model, Doctor of Philosophy, Element, American Guide Series, Digitalization, APQ, ICH, Quality management system, Guide, Clinical quality management system, Program, NORTH, International Society, Medication, Association, Process performance qualification protocol, ISPE, FDA, Solution, Compliance, Risk management

NORTH BETHESDA, Md., Oct. 17, 2022 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) announced the release of the ISPE APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS). This Guide provides a quality management framework for assessing and advancing an organization's PPPQMS maturity level by evaluating the following aspects:

Key Points: 
  • The International Society for Pharmaceutical Engineering (ISPE) announced the release of the ISPE APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS).
  • NORTH BETHESDA, Md., Oct. 17, 2022 /PRNewswire-PRWeb/ -- The International Society for Pharmaceutical Engineering (ISPE) announced the release of the ISPE APQ Guide: Process Performance & Product Quality Monitoring System (PPPQMS) .
  • This Guide provides a quality management framework for assessing and advancing an organization's PPPQMS maturity level by evaluating the following aspects:
    "A PPPQMS is an element of the Pharmaceutical Quality System and required for monitoring, analyzing, controlling and improving the process performance and product quality.
  • In addition to maintaining a state of control, an effective Process Performance and Product Quality Monitoring System (PPPQMS) enables continual improvement and proactively identifies the need for product quality and process improvements.

LIXTE BIOTECHNOLOGY ANNOUNCES APPROVAL OF A PHASE 1B/2 RANDOMIZED TRIAL OF DOXORUBICIN +/-LB-100 IN ADVANCED SOFT TISSUE SARCOMAS TO BE CONDUCTED BY THE SPANISH SARCOMA GROUP

Retrieved on: 
Thursday, October 13, 2022
CA, U.S. Securities and Exchange Commission, Agencia Espacial Mexicana, Drug Quality and Security Act, AEMPS, Disease, Mesenchyme, Sarcoma, Patient, Doxorubicin, Hospital, Teaching hospital, DNA repair, Medication, Research, Oncology, Cell, Securities Act of 1933, Cancer, III, Company, Anthracycline, Toxicity, CEO, GEIS, Patent, Securities Exchange Act of 1934, Safety, Spanish Agency of Medicines and Medical Devices, GLOBE, Clinical trial, DNA, PP2A, Failure, Terminology, Pharmaceutical industry

In animal models, LB-100 has consistently enhanced the anti-tumor activity of doxorubicin without apparent increases in toxicity.

Key Points: 
  • In animal models, LB-100 has consistently enhanced the anti-tumor activity of doxorubicin without apparent increases in toxicity.
  • Dr. Kovach continued, This study was designed and will be carried out by the Spanish Sarcoma Group ( Grupo Espaol de Investigacin en Sarcomas, or GEIS ).
  • GEIS was formed in 1994 by oncologists from four hospitals and has grown to include members from more than 60 medical centers across Spain.
  • GEIS will lead a European initiative to conduct a Phase 1/randomized II trial exploring the combination of doxorubicin plus LB-100 in first line of advanced soft tissue sarcomas.

Global AI in Healthcare Market Report 2022: Rising Utilization of Robots for Surgical and Rehabilitation Procedures Driving Growth - ResearchAndMarkets.com

Retrieved on: 
Friday, October 14, 2022
Biotechnology, Surgery, Oncology, Health, Artificial Intelligence, Medical Devices, Robotics, Technology, Adoption, National Association Medical Staff Services, Natural language processing, Virtual assistant, Hospital, Growth, Machine learning, Component, CAGR, Intelligence, Patient, Medical surge, Research, Invention, Cancer, Technology, Deep learning, Context, Diagnosis, Algorithm, End, Data mining, AI, Medication, Application, Health, Patent, Connection Machine, Artificial intelligence, COVID-19, National Accreditation Board for Hospitals & Healthcare Providers, Medical device, Health care

In 2021, the global AI in healthcare market was valued at US$6.71 billion, and is probable to reach US$41.70 billion by 2027.

Key Points: 
  • In 2021, the global AI in healthcare market was valued at US$6.71 billion, and is probable to reach US$41.70 billion by 2027.
  • The AI in healthcare market is projected to grow at a CAGR of 37.48%, during the forecast period of 2022-2027.
  • By Component: The report splits the global AI in healthcare market into three components: Software Solutions, Hardware and Services.
  • By End Users: The report splits the global AI in healthcare market into five end users: Hospital & Healthcare providers, Pharmaceutical & Biotechnology companies, Patients, Healthcare Payers and Others.

Marinus Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

Retrieved on: 
Friday, October 14, 2022
General Health, Neurology, Other Health, Health, Pharmaceutical, Cyprus Securities and Exchange Commission, Therapy, CV, Employment, Epilepsy, Patient, IV, GABAA, Financial compensation, Security (finance), Common stock, Seizure, Private Securities Litigation Reform Act, Company, CDKL5, Board, Adult, Medication, Ganaxolone, Brain, Forward-looking statement, Pharmaceutical industry

(Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to five new employees.

Key Points: 
  • (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the grant of inducement awards to five new employees.
  • The Compensation Committee of the Board of Directors of Marinus approved the grant of non-qualified stock options to purchase an aggregate of 46,999 shares of its common stock (the Common Stock) as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The stock options were granted as an inducement material to each of the employees entering into employment with Marinus in accordance with Nasdaq Listing Rule 5635(c)(4), and are subject to the terms and conditions of the applicable award agreement covering such grant.
  • Marinus is a commercial-stage pharmaceutical company dedicated to the development of innovative therapeutics for seizure disorders.

Allergy Partners Announces Collaboration with Aimmune Therapeutics to Provide PALFORZIA® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] Directly to Patients

Retrieved on: 
Thursday, October 13, 2022
Biotechnology, Pharmaceutical, Health, OIT, Risk, Observation, Diagnosis, Peanut, NOT, Partner, Education, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Patient, Allergy, Asthma, Research, Multimedia, Medication, Adrenaline, Food, Anaphylaxis, APT, Peanut allergy, Emergency, CEO, Ageing, FDA, Pharmaceutical industry, Hospital, Health insurance

Allergy Partners nation-wide care network provides high-quality health care for patients with asthma and allergic diseases, promoting education, research, and innovation in the field.

Key Points: 
  • Allergy Partners nation-wide care network provides high-quality health care for patients with asthma and allergic diseases, promoting education, research, and innovation in the field.
  • As a result of this collaboration, Allergy Partners will begin to provide PALFORZIA directly to patients through its specialty pharmacy, Allergy Partners Therapeutics (APT), across its entire national network of 64 practices and 126 community locations in 19 states.
  • Aimmune is committed to help ensure that all eligible patients who wish to access PALFORZIA are able to do so, and the announcement today of our collaboration with Allergy Partners marks another step toward that goal.
  • Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA:

Reata Pharmaceuticals Announces that the FDA Does Not Plan to Hold an Advisory Committee Meeting to Discuss the NDA for Omaveloxolone for Friedreich’s Ataxia

Retrieved on: 
Thursday, October 13, 2022
Health, FDA, Neurology, Genetics, General Health, Pharmaceutical, Biotechnology, U.S. Securities and Exchange Commission, Cardiomyopathy, Disease, Therapy, Fatigue, Review, Annual report, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Muscle weakness, Patient, Research, Inflammation, Nasdaq, Orphan drug, Food, Company, Hearing loss, Visual impairment, Reata Pharmaceuticals, Diabetes, Safety, Medication, Forward-looking statement, Literature, ATP, Oxidative stress, FDA, Omaveloxolone, Ataxia, European Commission, Pharmaceutical industry, NFE2L2

Based on literature and proprietary research, we believe Friedreichs ataxia affects approximately 5,000 children and adults in the United States and 22,000 individuals globally.

Key Points: 
  • Based on literature and proprietary research, we believe Friedreichs ataxia affects approximately 5,000 children and adults in the United States and 22,000 individuals globally.
  • The FDA has granted Orphan Drug, Fast Track, and Rare Pediatric Disease Designations to omaveloxolone for the treatment of Friedreichs ataxia.
  • The European Commission has granted Orphan Drug designation in Europe to omaveloxolone for the treatment of Friedreichs ataxia.
  • A New Drug Application for omaveloxolone for the treatment of Friedreichs ataxia is currently under review by the U.S. Food and Drug Administration.