HIV-1

Excision BioTherapeutics to Present Positive Data from its HSV-1 Keratitis Program, EBT-104, at the ASGCT 2024 Annual Meeting

Retrieved on: 
Lunedì, Aprile 22, 2024
Corneal opacity, AAV2, Nanopore, Rabbit, Immortalised cell line, Genomics, LTR, CRISPR, Genetic engineering, Abraxis BioScience, Infection, Gene, RNA, Recurrence, HeLa, Paratriathlon, Cell, HSK, AAV, Vero cell, Research, Pterygopalatine ganglion, FACS, PCR, Disease, DNA, Therapy, Viral load, HIV-1, Society, CDS, Gag, ICP0, Genome, Herpes simplex keratitis, LAT, Orientation, Annual general meeting, Edema, Valaciclovir, SAN, Vaccine

Herpes Simplex Keratitis (HSK), caused by the infection of herpes simplex virus type 1 (HSV-1) in the cornea, is a major cause of blindness worldwide.

Key Points: 
  • Herpes Simplex Keratitis (HSK), caused by the infection of herpes simplex virus type 1 (HSV-1) in the cornea, is a major cause of blindness worldwide.
  • Although current anti-HSV-1 therapies interfere with viral DNA replication, they do not eliminate HSV-1 reservoirs or prevent recurrence.
  • CRISPR/Cas-mediated gene editing can potentially address the underlying causes of the disease by directly eliminating the latent HSV-1 reservoirs.
  • The 440 guide RNA pairs formed with these 42 PlmCasX guide RNAs were tested in tissue culture for DNA excision efficiency.

FDA Approves Biktarvy® Label Update With Data for Pregnant Adults With HIV

Retrieved on: 
Venerdì, Aprile 26, 2024
Research, Pharmaceutical, Consumer, Infectious Diseases, Hospitals, Clinical Trials, Science, Baby, Maternity, Biotechnology, Women, AIDS, FDA, Health, University, Boxed warning, Gilead Sciences, Safety, PWH, Pregnancy, Pharmacokinetics, Woman, Food, CDC, Doctor of Philosophy, PCR, Tablet, Incidence, HIV-1, STR, HIV, DHHS, Associate, Plasma, National Medical Association

This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.

Key Points: 
  • This update makes Biktarvy the only second-generation integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) with in-label clinical trial data and FDA approval in virologically suppressed adults who are pregnant.
  • Additionally, guidelines recommend continuing Biktarvy for PWH already on treatment who are virologically suppressed and tolerating treatment well who may become pregnant.
  • “This label update marks an important milestone for Biktarvy, reinforcing its efficacy profile for pregnant PWH, an often understudied and most vulnerable community in clinical research,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences.
  • “Not only is Biktarvy an alternative regimen for use in pregnancy, but people of childbearing potential can also remain on Biktarvy if they become pregnant.

Phathom Pharmaceuticals Launches Direct-to-Consumer Campaign, “VOQUEZNA Can Kick Some Acid”

Retrieved on: 
Martedì, Marzo 26, 2024
Connected, HIV-1, Amazon Prime Video, Breast milk, Face, Hypoesthesia, Patient, Chronic pain, Clostridioides, Heartburn, Lymph, Magnesium, Diarrhea, Myalgia, Spine, Allergy, Muscle weakness, Vonoprazan, Stomach, Vitamin, Dizziness, Potassium, Hip, Risk, Tongue, Chills, DTC, Safety, Food, PPI, Rash, Food and Drug Administration, GERD, Enzyme inhibitor, Skin, Esophagitis, HIV, Rilpivirine, Kidney, FDA, Esophagus, B-12, Weakness, Infection, Indigestion, Smart TV, Seizure, Inflammation, Polyp, Calcium, Extrapyramidal system, Bone fracture, Nausea, Spasm, Urine, Fever, Clostridioides difficile, Bleeding, Blood, Wrist, Blister, Vitamin B12, Human, Medicine, Pharmaceutical industry

FLORHAM PARK, N.J., March 26, 2024 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal (GI) diseases, today announces the launch of its new broadcast ad and full-scale, Direct-to-Consumer (DTC) campaign, “VOQUEZNA Can Kick Some Acid,” to raise awareness of its powerful first-in-class treatment and encourage people to speak to their doctor about this new treatment option. VOQUEZNA (vonoprazan) is indicated for the healing and maintenance of healing of all severities of Erosive Esophagitis (EE), also referred to as Erosive GERD, and for the relief of related heartburn. VOQUEZNA represents the first major innovation to the U.S. Erosive GERD market in over 30 years.1

Key Points: 
  • The campaign will also be featured on consumer-facing platforms across Facebook, Instagram, waiting room TVs in doctor offices, and digital banner ads.
  • “Phathom is excited to launch our first campaign directly to, and for, the people whose lives we strive to improve every day.
  • To view a video of the “VOQUEZNA Can Kick Some Acid” commercial, click here.
  • Talk with your healthcare provider about the possibility of fundic gland polyps if you have been on VOQUEZNA for a long time.

U.S. FDA Approves Expanded Indication for Gilead’s Biktarvy® to Treat People with HIV with Suppressed Viral Loads, Pre-existing Resistance

Retrieved on: 
Lunedì, Febbraio 26, 2024
AIDS, FDA, Health, Hospitals, Pharmaceutical, Biotechnology, Infection, Division, Week, Doctor of Philosophy, Gilead Sciences, HIV-1, Drug resistance, MD, PWH, Science, Food, DHHS, Boxed warning, Hospital, Life, Risk, Safety, NRTI, RNA, History, Public, Guideline, DTG, Harvard Medical School, Mutation, Tablet, HIV, Vaccine

HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.

Key Points: 
  • HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH.
  • The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes.
  • “Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH.
  • There were also zero cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population.

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

Retrieved on: 
Lunedì, Febbraio 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: 
Giovedì, Febbraio 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.

EQS-News: Just – Evotec Biologics expands development and manufacturing agreement with ABL for broadly neutralising antibodies against HIV

Retrieved on: 
Mercoledì, Febbraio 7, 2024
Partnership, Federal, Human services, Infection, CGMP, HIV, ABL, Government, MDAX, HIV-1, EVO, National Institutes of Health, Just, WHO, NIAID, Bangladesh Technical Education Board, Frankfurt Stock Exchange, Pharmaceutical industry

The new agreement builds on previous collaborations between Just – Evotec Biologics and ABL to design highly efficient manufacturing processes for broadly neutralising antibodies (“bNAbs”) against HIV.

Key Points: 
  • The new agreement builds on previous collaborations between Just – Evotec Biologics and ABL to design highly efficient manufacturing processes for broadly neutralising antibodies (“bNAbs”) against HIV.
  • Dr Matthias Evers, Chief Business Officer of Evotec, commented: “We are excited to expand our long-standing partnership with ABL to include the development of a third bNAb.
  • The development of safe and efficacious HIV-1 treatments and prevention strategies remains one of the highest priorities of the NIAID.
  • No financial details of the agreement between Just – Evotec Biologics and ABL were disclosed.

Uvax Bio Announces Dosing of First Participant in Phase 1 Clinical Trial Evaluating Two Vaccines to Prevent HIV-1 Infection

Retrieved on: 
Martedì, Gennaio 30, 2024
AIDS, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, HIV-1, Subtypes of HIV, Animal, HIV, Computational biology, Safety, UFO, Immunization, Serum, Env, Vaccine

“UVAX-1107 and UVAX-1197 represent an advancement in HIV vaccine technology with industry-recognized innovations in our antigen design and delivery.

Key Points: 
  • “UVAX-1107 and UVAX-1197 represent an advancement in HIV vaccine technology with industry-recognized innovations in our antigen design and delivery.
  • Uvax Bio expects to report topline data from the Phase 1 trial in the fourth quarter of 2024.
  • The novel protein nanoparticle vaccine candidates are designed for active immunization and are intended to prevent HIV-1 infection.
  • Furthermore, preliminary screening assays demonstrated appreciable neutralization in serum when tested against a panel of primary HIV-1 isolates.

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Retrieved on: 
Martedì, Gennaio 2, 2024
Medical Subject Headings, Condom, Marketing, HIV-1, Tenofovir disoproxil, INN, Risk, Immune system, Health care, HIV/AIDS, Infection, Mylan, ATC, AIDS, International, Emtricitabine, Blood, Language, European Medicines Agency, Food, HIV, Tablet, Select, Subtypes of HIV, Patient, Cell, NRTI, Anatomy, Medicine, IIA, Pre-exposure prophylaxis, Generic drug

Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Emtricitabine/Tenofovir disoproxil Mylan, emtricitabine,tenofovir disoproxil, Date of authorisation: 16/12/2016, Revision: 15, Status: Authorised

Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

Retrieved on: 
Martedì, Gennaio 2, 2024
Liver, Medical Subject Headings, Common, Diarrhea, Marketing, HIV-1, European Commission, Agency, Protease, HIV, INN, Immune system, Upper respiratory tract infection, ATC, Nelfinavir, Depression, EMA, AIDS, International, Capsule, European, Ageing, Nausea, Blood, Language, European Medicines Agency, Infection, Food, Ritonavir, Tablet, Reproduction, Select, Patient, Human, Liver disease, Anatomy, Medicine, IIA, Lopinavir, Viral load, Vaccine

Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Kaletra, lopinavir,ritonavir, Date of authorisation: 19/03/2001, Revision: 62, Status: Authorised