Pre-exposure prophylaxis

Invivyd Provides PEMGARDA™ Launch Update and Announces 2024 Net Product Revenue Guidance in the Range of $150 Million to $200 Million

Retrieved on: 
Thursday, April 4, 2024

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points: 
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • With product now available, today we are providing initial PEMGARDA net product revenue guidance in the range of $150 million to $200 million for the full year 2024.
  • For additional information about PEMGARDA, please see the full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.
  • Those who plan on participating are advised to join 15 minutes prior to the start time.

Invivyd Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, March 28, 2024

“We made remarkable progress throughout 2023 and in recent months.

Key Points: 
  • “We made remarkable progress throughout 2023 and in recent months.
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • Cash Position: Cash and cash equivalents were $200.6 million as of December 31, 2023.
  • Basic and diluted net loss per share was $1.81 for the year ended December 31, 2023, compared to $2.23 for the year ended December 31, 2022.

Invivyd Announces FDA Authorization for Emergency Use of PEMGARDA™ (Formerly VYD222) for Pre-exposure Prophylaxis (PrEP) of COVID-19

Retrieved on: 
Friday, March 22, 2024

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

Key Points: 
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • “The PEMGARDA EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the U.S.
  • It was developed using INVYMAB™, the company’s platform approach which combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
  • The severity of the reactions was generally mild (17/27) or moderate (8/27), but two reactions were life-threatening.

$1 Million Fund Honoring LGBTQ+ Champion Glen Spencer is Making Big Impacts

Retrieved on: 
Tuesday, March 19, 2024

PHOENIX, March 19, 2024 /PRNewswire/ -- Spectrum Medical Care Center and its executive leadership established the "Glen Spencer Ending the HIV Epidemic Fund" in 2022 to honor Glen Spencer's legacy and dedication to increasing HIV awareness throughout the LGBTQ+ community. It is focused on curtailing HIV infections and promoting public health by committing $1 million over the course of four years.

Key Points: 
  • It is focused on curtailing HIV infections and promoting public health by committing $1 million over the course of four years.
  • "This is why fund recipients are our valued partners; their services are already touching the lives of many people.
  • Together we are all creating a wide safety net, one that we believe would make Glen Spencer very proud."
  • "Glen was bigger than life and is still sorely missed," said Spectrum Medical Care Center Director of Marketing and Community Engagement Victor Avila.

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

Retrieved on: 
Tuesday, March 5, 2024

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.

Lack of access to health care is partly to blame for skyrocketing HIV rates among gay Black men

Retrieved on: 
Friday, February 9, 2024

But the medical achievements that have made those lives better and created longer life expectancies have not benefited all communities.

Key Points: 
  • But the medical achievements that have made those lives better and created longer life expectancies have not benefited all communities.
  • In fact, some communities still have higher rates of new cases of HIV, the virus that causes AIDS.
  • Black queer men are six times more likely to die as a result of HIV-related complications when compared with queer men of different races.
  • Finally, data released in 2016 revealed that if the rates then of new HIV cases persisted, an estimated 1 in 2 Black queer men would acquire HIV in their lifetime.

The question of risky behavior

  • The wide reach of HIV in the Black queer community is not due to members of that community having more sex, or using protection less, or having more partners than queer people of other racial or ethnic backgrounds.
  • In fact, long-standing studies have shown that when Black queer men have access to appropriate health care, they use condoms more often, and test themselves for HIV more often, than queer men of other races.
  • According to those studies, Black queer people have a higher risk of contracting HIV than those others because their communities are more tightly knit – despite behaving more safely than others.
  • As a result of social stigma and discrimination, Black queer men are more likely to have sexual relationships within their own racial group.

A perfect storm of racism and homophobia

  • But in order to receive PrEP, for instance, one must first locate a provider who is willing to prescribe the medicine.
  • There are examples of doctors simply refusing to prescribe it out of fear of “increased promisciuty.” This sentiment is often rooted in racism and homophobia.
  • Though HIV care and PrEP are broadly covered under the Affordable Care Act, that often means only the cost of the prescriptions.

Lowering the risks

  • My research typically uses interviews of Black queer men to better understand how Black gay men experience and face structural barriers such as access to testing and adequate housing.
  • Most men I interview are living with HIV and offer insights on their lived experiences and professional expertise with great vulnerability and power.
  • Another man I interviewed lives in Los Angeles and pointed out that the younger generation has had limited education about the risks of Black gay life.


Deion Scott Hawkins does not work for, consult, own shares in or receive funding from any company or organization that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

Emergent BioSolutions Awarded Procurement Contract Valued up to $235.8 Million to Supply BioThrax® (Anthrax Vaccine Adsorbed) to the U.S. Department of Defense

Retrieved on: 
Thursday, January 11, 2024

GAITHERSBURG, Md., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.

Key Points: 
  • GAITHERSBURG, Md., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease.
  • The new contract with the U.S. Department of Defense (DoD) and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, is comprised of a five-year base agreement ending on September 30, 2028, and an additional five-year option that would extend the contract to September 30, 2033.
  • “As a part of our mission to protect and enhance lives, Emergent is proud to continue supporting and preparing our nation’s service members who have a high risk of exposure to anthrax bacteria by supplying BioThrax vaccine,” said Paul Williams, senior vice president, products head at Emergent.
  • “This new contract award is a testament to the importance of Emergent’s medical countermeasures portfolio, and we look forward to delivering on our commitments to the U.S. DoD.”
    Under the initial five-year IDIQ contract, there is a guaranteed purchase minimum of $20.1 million, with future orders estimated to be at least $20 million for each following year for a total award value up to $235.8 million.

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

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

EverGlade Consulting Funding Alert: BARDA Funding for Next-Generation Therapeutics and Vaccines for COVID-19 available through Rapid Response Partnership Vehicle (RRPV)

Retrieved on: 
Wednesday, December 6, 2023

CHARLESTON, S.C., Dec. 6, 2023 /PRNewswire/ -- The Rapid Response Partnership Vehicle (RRPV) Consortium is a joint initiative with the Biomedical Research and Development Authority (BARDA) to promote research and development in response to pandemics or public health emergencies. The RRPV focuses on accelerating the development, regulatory approval, commercialization, and maintenance of medical countermeasures against threats like pandemic influenza, emerging infectious diseases, and other biological threats.

Key Points: 
  • RRPV seeks to address the capability gap identified by BARDA in developing therapeutics, particularly those offering protection through Pre-exposure Prophylaxis (PrEP) and treatment against new SARS-CoV-2 variants.
  • "EverGlade Consulting acknowledges the significant potential that RRPV offers to public health," remarked Eric Jia-Sobota, founder of EverGlade Consulting.
  • If your company has considered applying for BARDA funding, EverGlade can help you make that determination and pursue a successful contract.
  • Our team has helped both large and small companies prepare, submit, and win applications for federal funding.

Gilead Sciences Announces New Clinical Trial in Europe to Assess Lenacapavir for HIV Prevention as Part of Landmark Purpose Program

Retrieved on: 
Wednesday, October 18, 2023

Gilead Sciences, Inc. (Nasdaq: GILD) today announced PURPOSE 5, the first Phase 2 clinical trial to evaluate an investigational long-acting HIV prevention option in Europe.

Key Points: 
  • Gilead Sciences, Inc. (Nasdaq: GILD) today announced PURPOSE 5, the first Phase 2 clinical trial to evaluate an investigational long-acting HIV prevention option in Europe.
  • HIV continues to be a public health threat across Europe, where in 2022 more than 100,000 people were newly diagnosed with HIV.
  • PURPOSE 1-5 is the most comprehensive and diverse program for an investigational HIV PrEP program ever conducted.
  • The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.