PWH

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

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금요일, 4월 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.

ACTG Presents Study at CROI Demonstrating Efficacy of Long-Acting Injectable Treatment Among People Who Had Previously Been Unable to Maintain Viral Suppression on Daily Oral Medication

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수요일, 3월 6, 2024
Infection, Chair, Bangladesh Technical Education Board, Mental health, Injection (medicine), University of Alabama, Rilpivirine, Fungal infection, NIAID, Arm, CROI, PWH, Quality of life, ACTG, Johnson & Johnson, Data monitoring committee, Conference, Health, University, ART, UM1, Male, DSMB, ViiV Healthcare, HIV, Failure, University of North Carolina, Vaccine

“ACTG is thrilled to present this ground-breaking study at CROI,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles.

Key Points: 
  • “ACTG is thrilled to present this ground-breaking study at CROI,” said ACTG Chair Judith Currier, M.D., M.Sc., University of California Los Angeles.
  • Participants received incentives and support to adhere to their daily oral medication to first achieve viral suppression and if successful, they were randomized to either receive long-acting injectable treatment every four weeks or continue taking daily oral medication.
  • The long-acting injectable treatment was more effective than the daily oral medication at maintaining virologic suppression and avoiding treatment-related discontinuation.
  • Twenty-eight participants receiving the long-acting injectable treatment experienced regimen failure (defined as virologic failure or treatment discontinuation), compared to 47 receiving daily oral medication.

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

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월요일, 2월 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

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월요일, 2월 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.

Centessa Pharmaceuticals to Present Additional 52-Weeks of Continuous Treatment Data from Third Year (Part 5) of Ongoing Phase 2a Study of SerpinPC for the Treatment of Hemophilia at the 17th Annual Congress of the European Association for Haemophilia and

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금요일, 2월 9, 2024
Society, PWH, Pharmacokinetics, Part, Safety, Haemophilia, ASH, CNTA, APC, Male, Patient, Person, Pharmaceutical industry

The Company previously shared Part 5 results during a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting.

Key Points: 
  • The Company previously shared Part 5 results during a poster presentation at the 65th American Society of Hematology (ASH) Annual Meeting.
  • SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.
  • “EAHAD provides an exciting opportunity to highlight the therapeutic potential of SerpinPC,” said Saurabh Saha MD PhD, Chief Executive Officer of Centessa.
  • “The compelling data from the ongoing Phase 2a study further demonstrate the potential for SerpinPC to be a convenient subcutaneous treatment with a differentiated safety profile for people living with hemophilia.

Centessa Pharmaceuticals to Present Additional 52-Weeks of Continuous Treatment Data from Third Year of Ongoing Phase 2a Study of SerpinPC for the Treatment of Hemophilia at American Society of Hematology (ASH) Annual Meeting

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목요일, 11월 2, 2023
Fibrinolysis, Person, Policy, Haemophilia, Serpin, Society, ASH, Pharmacokinetics, Male, APC, 52 Weeks Make A Year, Part, PWH, Safety, CNTA, Pharmaceutical industry

SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.

Key Points: 
  • SerpinPC is an investigational subcutaneously administered novel inhibitor of activated protein C (APC) in registrational studies for the treatment for hemophilia B, with or without inhibitors.
  • The Phase 2a study (AP-0101) is a first-in-human open-label multicenter study to investigate the safety, tolerability, pharmacokinetics and efficacy of subcutaneous doses of SerpinPC in male participants with severe hemophilia.
  • The Company has reported results from Parts 1-4, with results from Parts 3 and 4 shared during an oral presentation at ASH on December 10, 2022 .
  • Centessa plans to make the poster available at https://investors.centessa.com/events-presentations after the session concludes and in accordance with ASH’s embargo policy.

Gilead Demonstrates the Impact of Global Collaboration in Advancing HIV Research and Health Equity at EACS 2023

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월요일, 10월 16, 2023
Health, Hospitals, Research, Pharmaceutical, Science, Biotechnology, Partnership, PWH, Lenacapavir, XVII International AIDS Conference, 2008, Doctor of Philosophy, HIV Prevention Trials Network, Faculty, Drug development, Anxiety, Abstract, Drug resistance, European, EACS, Success, MD, Elton John AIDS Foundation, Risk, Chicano Art: Resistance and Affirmation, HIV-1, Death, Safety, HIV, EECA, CAPELLA, ART, DAI, Patient, CEST, Mental health, Education, Insomnia, Person, Mental, RSP, Tablet, Gilead Sciences, AIDS, Depression, History, Boxed warning, Elton, Conference, Monogram, Pharmaceutical industry, Medical device, Vaccine, Empowerment, Bictegravir/emtricitabine/tenofovir alafenamide

As a leader in HIV innovation, Gilead will provide an update on its signature initiatives, key collaborations and share new scientific data from its HIV research and development programs.

Key Points: 
  • As a leader in HIV innovation, Gilead will provide an update on its signature initiatives, key collaborations and share new scientific data from its HIV research and development programs.
  • Additional lenacapavir data presented at EACS 2023 will provide insight into the therapy’s resistance profile.
  • The mental health outcomes reported by participants in BICSTaR over a two-year period will also be presented at EACS 2023.
  • Mental health impairments can further increase the risk of negative health outcomes at every stage of the HIV care continuum.

Pilot Wave Holdings Receives $6MM Credit Facility from Aequum Capital

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화요일, 7월 11, 2023
Aircraft pilot, Growth, Omnichannel, Acquisition, Pilot wave theory, PWH, Online shopping

CHICAGO, July 11, 2023 /PRNewswire/ -- Pilot Wave Holdings ("Pilot Wave"), the world's leading technology-focused acquisition and growth firm, has closed on a $6MM credit facility with Aequum Capital, which will provide working capital to support continued growth and acquisitions of additional portfolio companies.

Key Points: 
  • CHICAGO, July 11, 2023 /PRNewswire/ -- Pilot Wave Holdings ("Pilot Wave"), the world's leading technology-focused acquisition and growth firm, has closed on a $6MM credit facility with Aequum Capital, which will provide working capital to support continued growth and acquisitions of additional portfolio companies.
  • "We are thrilled to secure this credit line from Aequum, as it empowers PWH to forge ahead in the dynamic world of e-commerce," said Arik Oganesian, head of E-Commerce at Pilot Wave.
  • Pilot Wave employs a distinctive approach to business, focusing on investing in and acquiring small businesses and leveraging top-notch data and analytics to fuel their growth.
  • "This is a great first step in the relationship between Aequum and PWH," said Eric Weisheit of Aequum Capital.

Merck Opens Enrollment in New Phase 3 Clinical Trials with Investigational Once-Daily Islatravir in Combination with Doravirine for Treatment of HIV-1 Infection

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수요일, 2월 22, 2023
Research, Infectious Diseases, Clinical Trials, Biotechnology, AIDS, Health, Pharmaceutical, General Health, Science, MSD, PWH, Infection, Randomness, Management of HIV/AIDS, HIV, Conference on Retroviruses and Opportunistic Infections, HIV-1, NYSE, Fungal infection, Islatravir, Vargo, Subtypes of HIV, Bictegravir/emtricitabine/tenofovir alafenamide, Merck & Co., Conference, DOR, MRK, CROI, Pharmaceutical industry, Dietary supplement, Silviculture, Merck, R, Safety

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the company has opened enrollment in its new Phase 3 clinical program with investigational once-daily islatravir 0.25 mg in combination with doravirine 100 mg (DOR/ISL) for the treatment of HIV-1 infection.

Key Points: 
  • Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the company has opened enrollment in its new Phase 3 clinical program with investigational once-daily islatravir 0.25 mg in combination with doravirine 100 mg (DOR/ISL) for the treatment of HIV-1 infection.
  • Select Merck abstracts for islatravir at the Conference on Retroviruses and Opportunistic Infections (CROI) 2023 include:
    Switch to DOR/ISL (100/0.75MG) QD From B/F/TAF: Week 48 Results From a Phase 3 Trial.
  • For more than 35 years, Merck has been committed to scientific research and discovery (R&D) in HIV.
  • We remain committed to working hand-in-hand with our partners in the global HIV community to address the complex challenges that impede progress toward ending the epidemic.

Joan Eliasek Named New President of McKesson Canada

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목요일, 2월 9, 2023
Uniprix, McKesson Corporation, Pharmacy, PWH, Rexall (Canada), Cardinal Health, Anne, Distinction, Patient, University, Marketing, Nursing, Proxim

MISSISSAUGA, ON, Feb. 9, 2023 /CNW/ - McKesson Canada is pleased to announce the appointment of veteran executive Joan Eliasek as President of McKesson Canada.

Key Points: 
  • MISSISSAUGA, ON, Feb. 9, 2023 /CNW/ - McKesson Canada is pleased to announce the appointment of veteran executive Joan Eliasek as President of McKesson Canada.
  • As President, Eliasek leads McKesson's diversified portfolio of healthcare businesses in Canada including pharmaceutical distribution operations, biopharma and provider solutions, McKesson's network of independent pharmacies (I.D.A., Guardian, Remedy'sRx, The Medicine Shoppe, Uniprix and Proxim), e-commerce retailer Well.ca, and the Rexall Pharmacy Group.
  • "I am honoured to be leading a passionate team dedicated to improving the health outcomes of Canadians," Eliasek said.
  • Eliasek holds a Bachelor of Arts degree in Political Science and Business Administration from the University of Iowa.