HIV

Theratechnologies Reports Financial Results for the Fourth Quarter and Full Year of Fiscal 2023 and Provides 2024 Guidance

Retrieved on: 
Wednesday, February 21, 2024
Fiscal, Investment, FDA, See, Growth, Covenant, Pharmacy, Calendar, HFS, Exercise, Government, Annual report, Symantec Endpoint Protection, Weakness, Audit, Indian stock exchange, GAAP, History, Peptide, Element, Classification, Patient, Policy, Uncertainty, Corporation, Liquidity, HIV, Depreciation, Security (finance)

For the fourth quarter of Fiscal 2023, sales of EGRIFTA SV® reached $16,958,000 compared to $14,458,000 in the fourth quarter of the prior year, representing an increase of 17.3%.

Key Points: 
  • For the fourth quarter of Fiscal 2023, sales of EGRIFTA SV® reached $16,958,000 compared to $14,458,000 in the fourth quarter of the prior year, representing an increase of 17.3%.
  • In the fourth quarter of Fiscal 2023, Trogarzo® sales amounted to $6,494,000 compared to $6,963,000 for the same quarter of Fiscal 2022, representing a decrease of 6.7%.
  • Lower unit sales in the fourth quarter of Fiscal 2023, were also a result of higher inventory buildup in Fiscal 2022, a situation which has resolved itself in Fiscal 2023.
  • Net finance costs in the fourth quarter of Fiscal 2022 included interest on the Convertible Notes, whereas this amount was nil in the fourth quarter of Fiscal 2023.

Matinas BioPharma Successfully Reaches Agreement with FDA for a Single Phase 3 Registration Trial to Support an NDA for MAT2203 for the Treatment of Invasive Aspergillosis

Retrieved on: 
Tuesday, February 20, 2024
FDA, Food, Safety, Element, LNC, Patient, Probability, HIV, Cryptococcosis, Partnership, Pharmaceutical industry

BEDMINSTER, N.J., Feb. 20, 2024 (GLOBE NEWSWIRE) -- Matinas BioPharma (NYSE American: MTNB), a clinical-stage biopharmaceutical company focused on delivering groundbreaking therapies using its lipid nanocrystal (LNC) platform delivery technology, announces alignment with the U.S. Food and Drug Administration (FDA) on the design of a single Phase 3 registration trial of MAT2203 in patients with invasive aspergillosis who have limited treatment options (the “ORALTO” trial).

Key Points: 
  • “We are pleased to achieve alignment with the FDA on the design of a single Phase 3 trial to support the registration of MAT2203 for the treatment of invasive aspergillosis in patients with limited treatment options,” commented Dr. Theresa Matkovits, Chief Development Officer at Matinas.
  • “We greatly appreciate the opportunity to work collaboratively with the FDA, which was essential for reaching consensus on all critical elements of the registrational path for MAT2203.
  • “We are energized by the support and guidance from the FDA, and believe this alignment provides the requisite certainty to advance our partnership discussions for this important product.
  • We are pursuing every opportunity to secure a partner and to advance MAT2203 into this Phase 3 registration trial as quickly as possible.”

The Access to Advanced Health Institute Receives up to $12.7 Million to Develop Novel NanoAlum Adjuvant Formulation for Better Protection Against Tuberculosis and Pandemic Influenza

Retrieved on: 
Thursday, March 7, 2024
COVID-19, Research, Clinical Trials, Health Technology, Biotechnology, General Health, Pharmaceutical, Health, Science, Other Science, Hepatitis A, Senior, Infectious Disease Research Institute, Immune system, Toxicology, Doctor of Philosophy, Medicine, Multimedia, TLR, Government, Infection, Access, Defense, RTS, Vaccine, Notifiable disease, Shingles, Malaria, Unitary state, Respiratory syncytial virus, Formulation, Fungus, MPH, MCDC, Disease, Tuberculosis, OTA, Parasitism, HIV, Cancer

View the full release here: https://www.businesswire.com/news/home/20240307661956/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240307661956/en/
    This five-year prototype project will support AAHI’s development and optimization of “NanoAlum” – a novel nanoparticle adjuvant formulation, made from aluminum salts (“alum”).
  • Alum-adjuvanted vaccines have been less effective against diseases such as tuberculosis and influenza, which are more complex to target and can be challenging to manufacture because they require special sterilization methods.
  • AAHI’s NanoAlum formulation changes the size, shape, and charge of alum particles to enhance specific immune responses for better vaccine protection against complex diseases.
  • AAHI’s prototype project for MCDC will pair the combined 3M-052 and NanoAlum formulation with tuberculosis and pandemic influenza vaccine antigens.

Women’s Empowerment = Healthy Women: Join AHF on International Women’s Day

Retrieved on: 
Friday, March 8, 2024
AIDS, Health, Family, Consumer, Public Policy, Government, Advocacy Group Opinion, Philanthropy, Children, General Health, Foundation, White House, Federal Government, Women, State, Local, International, Woman, Education, AIDS Healthcare Foundation, AHF, IWD, Policy, HIV, Public, Birth control

“Without healthy women, we cannot have a healthy world – making International Women’s Day the perfect commemoration to raise awareness of the many issues, including harmful inequities, stigma, and discrimination, women of all ages globally face that keep them from succeeding in their lives,” said AHF Deputy Chief of Global Advocacy & Policy Loretta Wong.

Key Points: 
  • “Without healthy women, we cannot have a healthy world – making International Women’s Day the perfect commemoration to raise awareness of the many issues, including harmful inequities, stigma, and discrimination, women of all ages globally face that keep them from succeeding in their lives,” said AHF Deputy Chief of Global Advocacy & Policy Loretta Wong.
  • International Women’s Day was founded in 1911 and is observed annually on March 8.
  • The day recognizes the political, cultural, and economic achievements of women to accelerate their rights.
  • To learn more about AHF, please visit our website: www.aidshealth.org , find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare .

NIAID-Sponsored Study Shows N-803 Combined with Neutralizing Antibodies Could Lead to Sustained HIV Viral Control After Discontinuation of Antiretroviral Therapy

Retrieved on: 
Wednesday, March 6, 2024
Pharmaceutical, AIDS, Health, Clinical Trials, Infection, Bangladesh Technical Education Board, SHIV, AD8, Research, Virology, BCG, NIAID, FDA, Safety, Animal, Hook effect, NMIBC, Rockefeller University, ART, Viremia, Patient, NK, Harvard Medical School, HIV, HIV/AIDS, Immune system, Vaccine

Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir.

Key Points: 
  • Treatment with N-803 and bNAbs led to immune activation and transient viremia, but only limited reductions in the SHIV reservoir.
  • Upon ART discontinuation, all animals experienced viral rebound, followed by long-term virus control for up to 10 months in approximately 70% of those treated with N-803 and bNAbs.
  • “When combined with broadly neutralizing antibodies, N-803 has the potential to provide viral control without significant reduction in the viral reservoir, which further suggests that the complete eradication of this reservoir may not be required to induce sustained remission after discontinuing antiretroviral therapy."
  • Safety and efficacy have not been established by any Health Authority or Agency, including the FDA.

Biktarvy® Demonstrates High Rates of Viral Suppression in People With HIV and Comorbidities

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, AIDS, Hospitals, Health, Pharmaceutical, ARV, Week, Research, Doctor of Philosophy, CROI, Science, CAPRISA, TLD, Fever, Coinfection, TB, STR, Common, Health care, Organization, DTG, Drug resistance, Genotype, HBV, Fungal infection, Principal, Rifampicin, Seroconversion, Tablet, ALT, TDF, Conference, Safety, Biomarker, Pharmacokinetics, Integrase, Metabolism, Emtricitabine, Aes, Gilead Sciences, MD, FDA, Upper respiratory tract infection, Food, Cell, Risk, Prevalence, COVID-19, Death, Patient, HIV/AIDS, Tuberculosis, INSIGHT, HIV, Vaccine

“People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.

Key Points: 
  • “People with HIV and comorbid conditions or pre-existing treatment resistance can often face complex and evolving treatment needs.
  • The ALLIANCE trial is the first randomized clinical trial of TAF- vs TDF-based regimens in treatment naïve adults with HIV /HBV coinfection.
  • Additionally, ALLIANCE participants treated with Biktarvy exhibited numerically higher levels of HBV viral suppression and seroconversion.
  • The primary outcome measure is viral suppression rates at Week 24, defined as HIV-1 RNA ˂50 copies/mL.

N-803 Combined with Natural Killer Cells Showed Potential to Reduce HIV Viral Load in HIV Positive Subjects; Part of HIV Cure Study

Retrieved on: 
Tuesday, March 5, 2024
AIDS, Health, Infectious Diseases, Hospitals, Research, Science, Biotechnology, Infection, BCG, Medicine, MD, FDA, Safety, Hook effect, NMIBC, Rockefeller University, University, ART, Patient, Journal, NK, Management of HIV/AIDS, HIV/AIDS, HIV, Viral load, Immune system, Vaccine

ImmunityBio ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced data from a Phase 1 pilot study showed N-803 combined with natural killer cells could have the potential to reduce viral load in people living with HIV.

Key Points: 
  • ImmunityBio ( NASDAQ: IBRX ), a clinical-stage immunotherapy company, today announced data from a Phase 1 pilot study showed N-803 combined with natural killer cells could have the potential to reduce viral load in people living with HIV.
  • All participants in this Phase 1 study experienced significant reduction in infection levels following treatment with N-803.
  • HIV can disable NK cells—a frontline defense against viral infections—making it difficult to clear the infection.
  • The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells.

ViiV Healthcare Announces Interim Data at CROI Indicating Superior Efficacy of Long-Acting Injectable HIV Treatment Cabenuva (Cabotegravir + Rilpivirine) Compared to Daily Oral Therapy in Individuals Living With HIV Who Have Adherence Challenges

Retrieved on: 
Wednesday, March 6, 2024
Research, Infectious Diseases, Finance, Clinical Trials, Professional Services, Biotechnology, AIDS, Pharmaceutical, Health, Science, Infection, Bangladesh Technical Education Board, HIV/AIDS, RAMS, Janssen Pharmaceuticals, Failure, Aes, Rilpivirine, Fungal infection, GSK, NIAID, CROI, Research and development, Arm, ISR, Life, ACTG, Data monitoring committee, Pfizer, Johnson & Johnson, Partner (business rank), Conference, ART, History, MPH, Male, ViiV Healthcare, DSMB, Mental health, HIV, SOC, Viral load, VF, Vaccine

Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, said: “It’s estimated that one-third of people living with HIV in the United States struggle with maintaining viral suppression.

Key Points: 
  • Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, said: “It’s estimated that one-third of people living with HIV in the United States struggle with maintaining viral suppression.
  • Participants received comprehensive and incentivised adherence support while taking guideline-recommended, three-drug regimen oral ART, including dolutegravir and bictegravir-based regimens, to achieve viral suppression.
  • 24.1% of participants on LA-ART experienced regimen failure compared to 38.5% on SOC {difference -14.4 (98.75% CI–29.8%, -0.8%)}.
  • Three participants in the LA-ART arm had serious injection site reactions (ISR) and one participant discontinued due to an ISR.

Gilead and Merck Announce Phase 2 Data Showing an Investigational Oral Once-Weekly Combination Regimen of Islatravir and Lenacapavir Maintained Viral Suppression at Week 24

Retrieved on: 
Wednesday, March 6, 2024
Biotechnology, Hospitals, Health, Pharmaceutical, Clinical Trials, MSD, MRK, Week, Doctor of Philosophy, Gilead Sciences, Fungal infection, CROI, Islatravir, MD, AIDS, Science, Boxed warning, Female, Nausea, Conference, European, Safety, Stigma, Lenacapavir, Tablet, HIV, Viral load, Xerostomia, Merck & Co., Pharmaceutical industry

These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ).

Key Points: 
  • These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ).
  • At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA
  • The potent antiviral activities, along with pharmacokinetic profiles of islatravir and lenacapavir, support their development as an investigational once-weekly oral combination regimen.
  • No participants in the Biktarvy group had a viral load of more than 50 copies/mL at Week 24.

ViiV Healthcare and The American Academy of HIV Medicine Announce Fellowship to Improve HIV Prevention in Key Communities

Retrieved on: 
Tuesday, March 5, 2024
Biotechnology, FDA, AIDS, Health, Training, Pharmaceutical, Other Education, Other Philanthropy, Philanthropy, Research, Infectious Diseases, Education, Science, Clinical Trials, Acquisition, Pre-exposure prophylaxis, Pfizer, Incidence, Shionogi, Woman, Medicine, Fungal infection, GSK, CROI, HIV Medicine, Notifiable disease, Emergency medicine, Dawn, Conference, Gynaecology, Mentorship, Preceptor, Patient, MPH, ViiV Healthcare, HIV, Obstetrics, American Academy, Pharmaceutical industry

Today, ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, and the American Academy of HIV Medicine (AAHIVM) jointly announced the launch of The Dr.

Key Points: 
  • Today, ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, and the American Academy of HIV Medicine (AAHIVM) jointly announced the launch of The Dr.
  • Dawn K. Smith HIV Prevention Clinical Fellowship.
  • The fellowship will provide comprehensive HIV training to non-infectious disease clinicians serving communities disproportionately affected by HIV.
  • Dawn K. Smith HIV Prevention Clinical Fellowship, experienced HIV clinicians will provide that training in priority populations and areas, with a special emphasis on pre-exposure prophylaxis (PrEP).”
    The Dr.