HIV-1

NIAID/NIH recognizes the potency of UB-421 against multi-drug resistant HIV and receives the FDA approval to conduct a phase 2 clinical trial with UB-421

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Mercoledì, Agosto 31, 2022
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In this trial sponsored by the NIAID/NIH, UBP will be responsible for supplying the investigational drug, UB-421.

Key Points: 
  • In this trial sponsored by the NIAID/NIH, UBP will be responsible for supplying the investigational drug, UB-421.
  • UBP has been collaborating with NIAID since 2015 to study the unique characteristic properties of UB-421 for treatment of HIV.
  • The potent efficacy of UB-421 against HIV clinical isolates resistant to HIV broadly neutralizing antibodies, entry inhibitors, and other antiretroviral drugs is well documented.
  • "We are excited for the NIAID to recognize the effectiveness of UB-421 through extensive collaborative studies, and to sponsor a phase 2 clinical trial in multi-drug resistant HIV patients."

Theratechnologies Trogarzo® Data at AIDS 2022 Shows Potential for Improved Treatment Regimens

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Giovedì, Luglio 28, 2022
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Additional data highlights synergistic activities between Trogarzo and dolutegravir, etravirine, tenofovir alafenamide and lenacapavir, a long-acting investigational antiretroviral therapy (ARV).

Key Points: 
  • Additional data highlights synergistic activities between Trogarzo and dolutegravir, etravirine, tenofovir alafenamide and lenacapavir, a long-acting investigational antiretroviral therapy (ARV).
  • The new data provide key understandings on the potential of Trogarzo (ibalizumab) to evolve treatment paradigms for heavily treatment-experienced HIV populations on complex regimens.
  • These data support the proof of concept that administration of Trogarzo via both IM and SC injection weekly or every two weeks are potential future improvements in convenience and accessibility.
  • We are proud to continue to investigate improving treatment for people living with HIV on complex treatment regimens.

ViiV Healthcare and the Medicines Patent Pool Sign New Voluntary Licensing Agreement to Expand Access to Innovative Long-Acting HIV Prevention Medicine

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Giovedì, Luglio 28, 2022
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Access to an effective long-acting HIV prevention option could significantly contribute towards the goal of ending the epidemic.

Key Points: 
  • Access to an effective long-acting HIV prevention option could significantly contribute towards the goal of ending the epidemic.
  • In particular, voluntary licensing has enabled access to generic products containing another of ViiV Healthcares innovative medicines, dolutegravir, for at least 20 million people living with HIV in low- and middle-income countries, as of December 20214.
  • Deborah Waterhouse, CEO at ViiV Healthcare said, Todays announcement represents a potentially game-changing moment in HIV prevention.
  • Charles Gore, MPP Executive Director said, We are delighted to sign this voluntary licence with ViiV for cabotegravir LA for PrEP.

Scientific Innovation and Collaboration Highlighted at AIDS 2022 as Gilead Extends Leadership Efforts Toward Ending the Global HIV Epidemic

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Giovedì, Luglio 21, 2022
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The convergence of the COVID-19 pandemic and HIV epidemic has further highlighted how inequities result in adverse health outcomes.

Key Points: 
  • The convergence of the COVID-19 pandemic and HIV epidemic has further highlighted how inequities result in adverse health outcomes.
  • At AIDS 2022, Gilead will convene a diverse, global panel Working Together to End the Epidemic: Guided by the Voices on the Ground to discuss community perspectives and Gileads ongoing efforts to change the future of the HIV epidemic through catalytic collaboration.
  • Gilead is driving scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world, with the goal of ending the HIV epidemic for everyone, everywhere.
  • During AIDS 2022, Gilead will share new findings on HIV treatment and prevention strategies, as well as the latest updates from the companys continued pursuit of an HIV cure.

ROME Therapeutics Announces Publication of First Crystal Structure of a Human Endogenous Reverse Transcriptase in PNAS

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Giovedì, Giugno 30, 2022
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ROME Therapeutics , a biotechnology company harnessing the power of the dark genome for drug development, today announced a new publication in The Proceedings of the National Academy of Sciences (PNAS) which describes the first-ever X-ray crystallography structure of an endogenous reverse transcriptase specifically human endogenous retrovirus-K (HERV-K) reverse transcriptase (RT).

Key Points: 
  • ROME Therapeutics , a biotechnology company harnessing the power of the dark genome for drug development, today announced a new publication in The Proceedings of the National Academy of Sciences (PNAS) which describes the first-ever X-ray crystallography structure of an endogenous reverse transcriptase specifically human endogenous retrovirus-K (HERV-K) reverse transcriptase (RT).
  • A significant portion of the human genome is made up of endogenous retroviruses, which are associated with a range of serious diseases, including cancer.
  • In this publication, we describe for the first time the crystal structure of an endogenous reverse transcriptase, one known as HERV-K RT, and show that it has remarkable similarities to HIV RT, a well-known tractable drug target, said Dennis Zaller, Ph.D., Chief Scientific Officer of ROME.
  • Similarly, deeper insights into human endogenous RT could pave the way toward a new class of therapies for cancer and other serious diseases.

Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor

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Lunedì, Giugno 27, 2022
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Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established.

Key Points: 
  • Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established.
  • Lenacapavir is Gileads potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment of HIV-1 infection.
  • GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.
  • For more information about Gilead, please visit the companys website at www.gilead.com , follow Gilead on Twitter ( @Gilead Sciences ) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

AACC, NSF Announce Winning Teams of 2022 Community College Innovation Challenge

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Martedì, Giugno 21, 2022
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WASHINGTON, June 21, 2022 /PRNewswire/ -- Today, the American Association of Community Colleges (AACC), in partnership with the U.S. National Science Foundation (NSF), announced the three winning teams of this year's Community College Innovation Challenge (CCIC). 

Key Points: 
  • Bergen Community College, NJ; Front Range Community College, CO; and Columbus State Community College, OH took home winning titles following presentations of their STEM innovations to address real-world challenges
    WASHINGTON, June 21, 2022 /PRNewswire/ -- Today, the American Association of Community Colleges (AACC), in partnership with the U.S. National Science Foundation (NSF), announced the threewinning teams of this year's Community College Innovation Challenge (CCIC).
  • The annual competition seeks to strengthen entrepreneurial thinking among community college students by challenging them to develop STEM-based solutions to real-world problems.
  • The first, second and third-place winning teams and their innovations are listed below.
  • "The innovative ideas that were presented in the Community College Innovation Challenge were incredibly impressive," said Walter G. Bumphus, president and CEO of AACC.

Chembio Diagnostics Announces Expansion of Direct-to-Consumer Commercial Channel

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Mercoledì, Giugno 15, 2022
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HAUPPAUGE, N.Y., June 15, 2022 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Chembio) (Nasdaq:CEMI), aleading point-of-care diagnostic company focused on infectious diseases, today announced the launch of its direct-to-consumer commercial channel for the third-party SCoV-2 Ag Detect Self-Test in the U.S. market.

Key Points: 
  • HAUPPAUGE, N.Y., June 15, 2022 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Chembio) (Nasdaq:CEMI), aleading point-of-care diagnostic company focused on infectious diseases, today announced the launch of its direct-to-consumer commercial channel for the third-party SCoV-2 Ag Detect Self-Test in the U.S. market.
  • We are now offering the SCoV-2 Ag Detect Self-Test via our distribution network and directly through Chembio in the US.
  • In addition, we are now offering our SURE CHECK HIV Self-Test through e-commerce platforms in the UK and Brazil.
  • This commercial expansion increases our addressable market and is intended to enable deeper penetration of the market as at home testing volumes continue to grow.

Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA

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Martedì, Giugno 14, 2022
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Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.

Key Points: 
  • Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.
  • Cases of anaphylaxis, TEN, and Stevens-Johnson syndrome have also been reported with components of PAXLOVID (refer to NORVIR labeling).
  • If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.
  • Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis.

FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV

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Lunedì, Maggio 16, 2022
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As previously announced , the FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue.

Key Points: 
  • As previously announced , the FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue.
  • Following todays decision from the FDA, all activity can resume in the clinical studies evaluating injectable lenacapavir for HIV treatment and HIV PrEP.
  • During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir were not permitted across all lenacapavir studies.
  • Lenacapavir is Gileads potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection.