HIV-1

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

Retrieved on: 
Tuesday, March 26, 2024
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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: 
Monday, February 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: 
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

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Thursday, February 22, 2024
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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: 
Wednesday, February 7, 2024
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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: 
Tuesday, January 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: 
Tuesday, January 2, 2024
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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: 
Tuesday, January 2, 2024
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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

Phathom Pharmaceuticals Announces Commercial Availability of VOQUEZNA® (vonoprazan) Tablets, a Powerful First-In-Class PCAB for the Treatment of Erosive GERD and Relief of Associated Heartburn

Retrieved on: 
Tuesday, November 28, 2023
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“We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.

Key Points: 
  • “We are thrilled to announce the commercial availability of our first-in-class medication, VOQUEZNA, now available for the millions of people in the U.S. suffering from Erosive GERD,” said Martin Gilligan, Chief Commercial Officer at Phathom Pharmaceuticals.
  • “Erosive GERD is a highly prevalent condition affecting over 20 million people in the U.S.,3,4 many of whom experience troubling symptoms, including painful heartburn.
  • Phathom is offering programs for eligible patients who face coverage or affordability issues, including co-pay assistance for patients with commercial insurance.
  • for up to 6 months to maintain healing of Erosive Acid Reflux and for relief of heartburn related to Erosive Acid Reflux.

Uvax Bio Receives Approval to Initiate a Phase 1 Clinical Trial of Novel HIV-1 Protein Nanoparticle Vaccine Candidates in Australia

Retrieved on: 
Tuesday, December 19, 2023
AIDS, Health, Infectious Diseases, Clinical Trials, Pharmaceutical, Biotechnology, HIV-1, Env, Vaccine, Serum, GMP, Animal, UFO, HIV, Immunization, Aluminium, CpG

Uvax Bio, LLC , a privately held, clinical-stage vaccine company, today announced acknowledgement from Australian Therapeutic Goods Administration and approval from the Human Research Ethics Committee (HREC) to conduct a Phase 1 study of Uvax Bio's HIV-1 vaccine candidates in healthy volunteers in Australia.

Key Points: 
  • Uvax Bio, LLC , a privately held, clinical-stage vaccine company, today announced acknowledgement from Australian Therapeutic Goods Administration and approval from the Human Research Ethics Committee (HREC) to conduct a Phase 1 study of Uvax Bio's HIV-1 vaccine candidates in healthy volunteers in Australia.
  • Uvax Bio will work with their Australia-based clinical research partners Avance Clinical and the Nucleus Network study site to initiate this study in January 2024.
  • In a second preclinical immunogenicity study, immunization with Uvax Bio’s HIV-1 vaccine candidates elicited robust neutralizing antibody responses against the vaccine-matched virus in 99% of the animals.
  • “Our clinical team will immediately begin the preparation to initiate this trial in January 2024.”