Viral

Gilead to Present Late-Breaking Data and Real-World Evidence Highlighting Innovative Antiviral Portfolio and Research Pipeline at CROI 2024

Retrieved on: 
Monday, February 26, 2024
Biotechnology, FDA, AIDS, Health, Pharmaceutical, Research, Infectious Diseases, Hospitals, Science, COVID-19, Clinical Trials, Senior, Hepatitis B, CROI, Hook effect, RWE, STR, Viral, Virus, DTG, Mortality, Lenacapavir, Hepatitis, HBV, Vesatolimod, Fungal infection, HIV-1, MDR, PWH, HDV, Boxed warning, European, Islatravir, Tablet, European Commission, Liver disease, Omicron, Conference, Safety, ART, Civil service commission, Abstract, Bictegravir, Natural history, Virology, Emtricitabine, Gilead Sciences, MD, Food, Coinfection, Immunodeficiency, European Economic Area, Risk, Prevalence, Dexamethasone, Patient, Tuberculosis, INSIGHT, HIV, Pharmaceutical industry

Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.

Key Points: 
  • Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir.
  • Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented.
  • Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV).
  • Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone.

Atomic AI Announces Appointments of New Independent Member to its Board of Directors and Additions to the Scientific Advisory Board

Retrieved on: 
Thursday, February 22, 2024
Research, Other Health, General Health, Pharmaceutical, Infectious Diseases, Hospitals, Clinical Trials, Science, Cardiology, Biotechnology, FDA, Health, Other Science, Molecule, Organic chemistry, Viral, Senior, Janssen Pharmaceuticals, Dartmouth College, SAB, Neuroscience, Beclabuvir, PTC Therapeutics, University, RNA, Jan Vansina, RSV, HIV-1, Atomic, Johnson & Johnson, Stroke, Bristol Myers Squibb, MBA, BMS, Therapy, Journal, HCV, PTC, Drug discovery, Meanwell, McArdle Laboratory, American Academy, Royal Society, Daclatasvir, Harvard University, Asunaprevir, Doctor of Philosophy, Thrombosis, Rutgers University, Patient, Outline of physical science, American Chemical Society, Deep learning, Publication, Cancer, Medicinal chemistry, Pharmaceutical industry

Atomic AI, a biotechnology company fusing cutting-edge machine learning with state-of-the-art structural biology to unlock RNA drug discovery, today announced the appointment of Stuart Peltz, Ph.D. as an independent board member to the Atomic AI Board of Directors, and the additions of Percy Carter, MBA, Ph.D., and Nicholas Meanwell, Ph.D. to their Scientific Advisory Board (SAB).

Key Points: 
  • Atomic AI, a biotechnology company fusing cutting-edge machine learning with state-of-the-art structural biology to unlock RNA drug discovery, today announced the appointment of Stuart Peltz, Ph.D. as an independent board member to the Atomic AI Board of Directors, and the additions of Percy Carter, MBA, Ph.D., and Nicholas Meanwell, Ph.D. to their Scientific Advisory Board (SAB).
  • “We are extremely pleased to have these highly regarded, experienced biotech leaders join in our efforts and believe in our mission,” said Raphael Townshend, Ph.D., Founder and CEO of Atomic AI.
  • Peltz’s experience will help shape our strategy as we endeavor to streamline the discovery and development of novel therapies.
  • “They have demonstrated tremendous progress integrating deep learning foundation models with experimental results to be able to predict and optimize RNA structures to enable rational drug design.

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on: 
Sunday, March 10, 2024
Well, DER, Fungus, Capsule, TUR, Interest, Animal, Part, Exercise, Database, Viral, Hepatitis, Powder, Collection, Directive, Union, Nutrient, DSM-IV codes, Volume, CTD, Legislation, Literature, Fermentation, Diabetes, Pharmacopoeia, Inhalation, Committee, Monograph, NTA, WEU, DCP, AIDS, See, Mineral, Marketing, Safety, Plant, MRA, Autoimmunity, Directive 2001/83/EC, GMP, Documentation, Seed, Heart failure, Distillation, CHMP, MRP, European Medicines Agency, Guideline, Disorder, Mutual, Convention, State, Tablet, Community, Clinical trial, Rapporteur, European Commission, Woman, Medication package insert, Vitamin, Quality, Authority, GACP, SAWP, Pharmacovigilance, Civil service commission, HMPS, Science, Health, Bibliography, Section 4, Infection, Kampo, Commission, Abbreviation, Pathology, Prescription, Human, Medication, Reproduction, EMA, NCA, Chapter One, EDQM, TAM, European Pharmacopoeia, European Economic Area, Food, Regulation (European Union), COM, TCM, Administration, Mutual recognition, Procedure, Medicine, Herbal, Answer, Q&A, HIV, EudraLex, Cancer, Public, Medicinal plants

1

Key Points: 
    • 1
      Committee on Herbal Medicinal Products (HMPC)

      Questions & Answers on the European Union framework
      for (traditional) herbal medicinal products, including those
      from a ?non-European? tradition

      Table of Content
      1.

    • European Pharmacopoeia

      SAWP

      Scientific Advice Working Party

      SmPC

      Summary of Product Characteristics

      THMP

      Traditional Herbal Medicinal Product

      TUR

      Traditional Use Registration

      WEU

      Well-Established Use

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Terminology of herbal medicinal products (Q&A 1-4)

      Question 1
      What are herbal substances, herbal preparations, and herbal medicinal products?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 4
      Are food supplements regulated under the European Union (EU) pharmaceutical legislation
      for (traditional) herbal medicinal products ((T)HMPs)?
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Regulation of herbal medicinal products in the European Union (Q&A 511)

      Question 5
      Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
      products (HMPs), including traditional herbal medicinal products (THMPs), in the European
      Union (EU)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • These countries have,
      through the EEA agreement, adopted the complete Union acquis on medicinal products and are
      consequently parties to the Union procedures.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Specific provisions for traditional herbal medicinal products (Q&A 1221)

      Question 12
      Which indications can be granted for traditional herbal medicinal products (THMPs)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Nov. 2023
      Answer 17

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 29
      Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
      (registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
    • Discussion with Member States intended to be

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

HPV's Hidden Hand: New Study by Pusan National University Scientists Reveals Key Details in Head and Neck Cancer Microenvironment

Retrieved on: 
Wednesday, February 28, 2024
School, Neoplasm, Incidence, PKM2, Viral, Virology, Informatics, Assistant, Throat, Growth, Health informatics, Human papillomavirus infection, Branches of microbiology, Mouth, RNA, PKM, Tumor microenvironment, B cell, Ephrin, Patient, Glomus tumor, Journal, Tobacco, Medicine, Pusan National University, HPV, HNSCC, Head, Research, Nose, Cancer, EPHA2, Vaccine

BUSAN, South Korea, Feb. 28, 2024 /PRNewswire/ -- Head and neck squamous cell carcinoma (HNSCC) is a type of cancer that affects the mucous membranes of the mouth, nose, and throat. HNSCC is typically associated with tobacco exposure, alcohol abuse, and viral infections. The links between human papillomavirus (HPV) infection status and the molecular characteristics of HNSCC are not clearly defined.

Key Points: 
  • BUSAN, South Korea, Feb. 28, 2024 /PRNewswire/ -- Head and neck squamous cell carcinoma (HNSCC) is a type of cancer that affects the mucous membranes of the mouth, nose, and throat.
  • The links between human papillomavirus (HPV) infection status and the molecular characteristics of HNSCC are not clearly defined.
  • Therefore, the HPV infection could be considered a criterion for developing treatment strategies, thereby enabling precision medicine tailored to the patient's condition!
  • Title of original paper: Deciphering Head and Neck Cancer Microenvironment: Single–Cell and Spatial Transcriptomics Reveals Human Papillomavirus–Associated Differences

Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-14 February 2024

Retrieved on: 
Saturday, February 17, 2024
Penta, Committee, Infection, Leukopenia, Lotilaner, Atopic dermatitis, Cattle, Dog, Sheep, CVMP, InterDigital, Skin, Viral, Hyperthermia, Metritis, Chicken, Horse, Viremia, Classification, Drinking water, Cat, QRD, Guideline, The Committee

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.

Key Points: 
  • The Committee adopted by consensus a positive opinion for a variation requiring assessment for Strangvac to implement the outcome of the MAH’s signal management process to add adverse reactions in the product information.
  • The respective target species were cattle, pigs and sheep (one product), chickens, and squirrel monkeys (one product each).
  • Concept papers, guidelines
    Quality
    The Committee adopted an annex to the Guideline on quality aspects of pharmaceutical veterinary medicines for administration via drinking water on compatibility studies between veterinary medicinal products and biocidal products (EMA/CVMP/QWP/592906/2022) following close of public consultation.
  • The comments received during the consultation procedure were taken into account for the revision of the annex.

Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis

Retrieved on: 
Thursday, February 15, 2024
Fast Track, Recurrence, Scar, Inflammation, FDA, Quality of life, TSX, C-reactive protein, Myocarditis, Pericardial fluid, Pericarditis, Viral, CRDL, ODD, Safety, Pericardium, Therapy, Chronic pain, Fatigue, Length of stay, Patient, News, Disease, Heart, Hospital, Research, NRS, Priority review, Pharmaceutical industry

Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II Study

Key Points: 
  • Toronto, Ontario--(Newsfile Corp. - February 15, 2024) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the United States Food and Drug Administration ("FDA") has granted Orphan Drug Designation ("ODD") for the Company's lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis.
  • MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis.
  • The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis.
  • The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention.

Indaptus Therapeutics to Present at the 2024 BIO CEO & Investor Conference

Retrieved on: 
Thursday, February 15, 2024
Viral, Cancer, Outline, BIO, Therapy, Immune system, Conference, Pharmaceutical industry

NEW YORK, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announced today that Jeffrey A. Meckler, Chief Executive Officer, and Nir Sassi, Chief Financial Officer, will present a corporate update at the 2024 BIO CEO & Investor Conference.

Key Points: 
  • NEW YORK, Feb. 15, 2024 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP), a clinical stage biotechnology company dedicated to pioneering innovative cancer and viral infection treatments, announced today that Jeffrey A. Meckler, Chief Executive Officer, and Nir Sassi, Chief Financial Officer, will present a corporate update at the 2024 BIO CEO & Investor Conference.
  • The conference is being held on February 26 – 27, 2024 at the New York Marriott Marquis.
  • "We are excited to participate in the 2024 BIO CEO & Investor Conference to highlight our recent progress and outline our strategic vision for making a tangible difference in patients' lives."
  • To register for the conference: https://bcic.bio.org/registration
    Mr. Meckler and Mr. Sassi will be available for one-on-one meetings throughout the conference.

Aethlon Medical Announces Fiscal Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, February 14, 2024
Viral, Internet, Call, MAMC, Blood, Interest, Exosome, Marketing, Maulana Azad Medical College, Metastasis, Organ transplantation, Ethics, Interim, Intensive care medicine, COVID-19, Consolidated, DCGI, Virus, Patient, Clinical trial, Infection, Plasma, Insurance, Research, Travel, Cancer, Pharmaceutical industry

SAN DIEGO, Feb. 14, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December 31, 2023 and provided an update on recent developments. 

Key Points: 
  • ET
    SAN DIEGO, Feb. 14, 2024 /PRNewswire/ -- Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to treat cancer and life-threatening infectious diseases, today reported financial results for its fiscal third quarter ended December 31, 2023 and provided an update on recent developments.
  • "While our research and development team has started to quantify our internal data, the results, to date, are inconclusive.
  • Financial Results for the Third Quarter Ended December 31, 2023
    As of December 31, 2023, Aethlon Medical had a cash balance of approximately $8.0 million.
  • ET to review its financial results for its fiscal third quarter ended December 31, 2023 and recent corporate developments.

ProPhase Labs Announces Preliminary Positive Results for Dietary Supplement Equivir

Retrieved on: 
Wednesday, February 14, 2024
Prophase, COVID-19, Marketing, OTC, Food, Viral, Patient, Genomics, Immunity, Vaccine

Garden City, NY, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a next generation biotech, genomics and diagnostics company, today announced positive preliminary results from its Equivir dietary supplement comprehensive trial. Preliminary results indicate that this innovative OTC dietary supplement has the potential to support and maintain immunity, which – if confirmed at the end of the clinical trial program – may help reduce both the frequency and severity of upper respiratory illnesses including the common cold, flu, and Covid-19.

Key Points: 
  • Commercialization of Equivir anticipated after second trial is completed in Q2, 2024
    Garden City, NY, Feb. 14, 2024 (GLOBE NEWSWIRE) -- ProPhase Labs, Inc. (NASDAQ: PRPH), a next generation biotech, genomics and diagnostics company, today announced positive preliminary results from its Equivir dietary supplement comprehensive trial.
  • Each study enrolls 150 participants, randomly assigned to receive either Equivir or a placebo, with their health monitored over a 180-day period.
  • Preliminary results are as follows:
    Overall, in the initial 150 patient group there were approximately 46 incidences of upper respiratory viral infections.
  • Equivir is being developed with plans to market as an OTC dietary supplement.

ALLOVIR, INC. (NASDAQ: ALVR) DEADLINE ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against AlloVir, Inc.

Retrieved on: 
Tuesday, February 13, 2024
Viral, Court, Action Replay, News, Advertising, Complaint, District court, Virus, Patient, Defendant, Research, Security (finance)

If you purchased or acquired AlloVir securities, and/or would like to discuss your legal rights and options please visit AlloVir, Inc.

Key Points: 
  • If you purchased or acquired AlloVir securities, and/or would like to discuss your legal rights and options please visit AlloVir, Inc.
  • If you wish to serve as lead plaintiff, you must move the Court no later than March 19, 2024.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.