MedCity News

SEPTEMBER 20, 2022

A Merck HIV drug placed under multiple full and partial clinical holds last year is now clear to resume testing. The pharma giant is also dropping tests of the drug for HIV prevention. As part of a modified plan, Merck will test a lower dose of its experimental drug, islatravir.

FDA 98

FDA Pharma Biopharma 98

European Pharmaceutical Review

FEBRUARY 23, 2023

Two newer simplified treatment options are at least as effective as standard of care in achieving viral suppression, according to results from a world-first international study into second-line human immunodeficiency virus (HIV) therapy. D2EFT enrolled 831 patients from 14 countries. Patients were randomised to one of the three arms.

Medical 93

Medical Healthcare Healthcare Management 93

PM360

DECEMBER 20, 2023

Addimmune , which is exploring gene therapy technologies that treat and cure HIV, went the special purpose acquisition company (SPAC) route where a publicly traded company is created for the purpose of acquiring or merging with an existing company. An estimated five million people are living with HIV in the U.S. and Europe, 3.8%

Management 109

Management Marketing Healthcare Healthcare 109

Pharmaceutical Technology

AUGUST 23, 2022

Gilead Sciences has obtained the European Commission (EC) marketing authorisation for Sunlenca (lenacapavir) injection and tablets to treat human immunodeficiency virus (HIV) infection. A long-acting HIV capsid inhibitor, lenacapavir has a multi-stage mechanism of action. A decision on the approval is anticipated by 27 December.

Food and Drug Administration 119

Food and Drug Administration Food Marketing Medicine 119

European Pharmaceutical Review

NOVEMBER 17, 2022

An innovative ingestible sensor technology tested in an interventional clinical trial provided HIV patients with real-time antiretroviral dosage data , enabling them to better control their infection. The study is one of earliest that uses an FDA-approved ingestible sensor system for ARV therapy in HIV-infected adults.

Medical 89

Medical Medicine Recruitment Patients 89

MedCity News

OCTOBER 13, 2022

As VP of clinical research for hepatitis, respiratory and emerging viruses at Gilead, Anu Osinusi talked about the pharma company’s work in HIV and hepatitis and how her personal background informed her team’s work in developing a Covid-19 treatment. Gilead Sciences is a leader in the field of virology treatments.

Pharma 120

Pharma Biopharma 120

World of DTC Marketing

MARCH 23, 2022

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? The program was codified into law under the Food and Drug Safety and Innovation Act (FDASIA) in 2012.

Patients 200

Patients FDA Doctors Physicians 200

Pharmacy Times

JUNE 1, 2023

The primary medication therapies that can help with prophylaxis against HIV include pre-exposure prophylaxis and non-occupational post-exposure prophylaxis.

Medical 49

Medical 49

European Pharmaceutical Review

NOVEMBER 30, 2022

The European Commission (EC) has granted the first paediatric marketing authorisation for Gilead’s new low-dose tablet Biktarvy ® (bictegravir 30mg/emtricitabine 120mg/tenofovir alafenamide 15mg) in the European Union (EU) to treat human immunodeficiency virus (HIV). A milestone in the journey to overcoming HIV.

Marketing 87

Marketing Pharmaceutical 87

Pharmacy Times

JANUARY 3, 2024

Pharmacists involvement in HIV care and treatment has been shown to lead to clinically and statistically significant improvements in ART adherence, as well as greater viral load suppression for patients with HIV.

Leads 49

Leads Patients 49

European Pharmaceutical Review

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Gilead’s Sunlenca (lenacapavir), a capsid inhibitor for adults living with human immunodeficiency virus type 1 (HIV-1), who cannot be successfully treated with other available treatments. After 52 weeks, 83 percent of participants continued to have HIV RNA suppression.

Food and Drug Administration 83

Food and Drug Administration FDA Patients Food 83

Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

Medicine 117

Medicine Prospecting Safety Manufacturing 117

European Pharmaceutical Review

AUGUST 25, 2022

The European Commission (EC) has granted marketing authorisation to a new, twice yearly treatment option for people whose HIV no longer effectively responds to their current therapy. Lenacapavir provides an innovative long-acting HIV therapy option with the potential to transform the clinical landscape.”.

Physicians 80

Physicians Marketing Patients Medicine 80

European Pharmaceutical Review

OCTOBER 21, 2022

Clinical trial results presented at the US IDWeek conference, revealed a three-dose series of the HEPLISAV-B vaccine prevents hepatitis B virus (HBV) in HIV patients not previously vaccinated against or infected with the virus. The product will be given to HIV patients whose previous HBV vaccination failed to prevent against the virus.

Patients 76

Patients Food and Drug Administration Side effects Food 76

European Pharmaceutical Review

MAY 16, 2023

1 Since the first therapy using stem cells was developed in 1957, only few stem cell-based therapies have entered the clinic 1 as advanced therapy medicinal products (ATMPs). in a 2023 paper published in the Journal of Clinical Microbiology. To facilitate this, regulation of cell therapies has transformed at pace in recent decades.

Manufacturing 86

Manufacturing Medicine Marketing Medical 86

Pharmacy Times

DECEMBER 18, 2023

Using information from clinical studies and her experiences working in the field, Stephanie Kirk describes treatment options that are on the horizon, and how removing stigma is key in HIV care.

57

57

Pharmaceutical Technology

FEBRUARY 19, 2024

S-365598 is under clinical development by ViiV Healthcare and currently in Phase I for Human Immunodeficiency Virus (HIV) Infections (AIDS).

Healthcare 40

Healthcare Healthcare 40

Pharmaceutical Technology

DECEMBER 23, 2022

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Sunlenca (lenacapavir) plus other antiretroviral(s) (ARV) to treat human immunodeficiency virus type 1 (HIV-1) infection. A long-acting HIV capsid inhibitor, Sunlenca is intended for dosing twice a year.

Food and Drug Administration 59

Food and Drug Administration FDA Food Medicine 59

pharmaphorum

DECEMBER 2, 2022

New research from ViiV Healthcare has revealed a widespread gap in public knowledge and understanding of HIV worldwide, with three-quarters of people reporting that there are still negative perceptions of people living with HIV. Person-first language must be the absolute norm to help challenge HIV-related stigma and discrimination.

Healthcare 52

Healthcare Healthcare Media Physicians 52

Pharmaceutical Technology

DECEMBER 20, 2023

LC-002 is under clinical development by Genetic Immunity and currently in Phase II for Human Immunodeficiency Virus (HIV) Infections (AIDS).

40

40

Pharmaceutical Technology

APRIL 17, 2023

Clinical-stage biotechnology company Smart Immune has secured $5m in equity investment from the Bill & Melinda Gates Foundation for expediting the development of its thymus-empowered ProTcell platform for the treatment of cancer and infectious diseases. It will also reverse thymic involution using its T-cell progenitor-based therapy.

Patients 52

Patients 52

Pharmaceutical Technology

SEPTEMBER 14, 2023

(Islatravir + ulonivirine) is under clinical development by Merck and currently in Phase II for Human Immunodeficiency Virus (HIV) Infections (AIDS).

52

52

Pharmacy Times

DECEMBER 6, 2022

Dena Dillon, HIV clinical pharmacy specialist at the University of Iowa Health Care, discusses 2-drug regimens for individuals living with HIV.

49

49

Pharmaceutical Technology

APRIL 18, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: HIV peptides. However, not all innovations are equal and nor do they follow a constant upward trend. These can serve as an important component of a vaccine.

Pharmaceutical 59

Pharmaceutical Leads Medical Medicine 59

Pharmacy Times

JUNE 22, 2023

Six-month preexposure prophylaxis (PrEP) dispensing supported by HIV self-testing resulted in PrEP adherence after 12 months and less visits to clinical sites.

49

49

PM360

JUNE 8, 2023

When patients living with HIV or at risk for contracting the virus miss their appointments at the CARE Center at St. Mary Medical Center in Long Beach, California, they can’t be prescribed the critical medications they need. Learn how you can empower patients and make an impact at the point of care by visiting lifesciences.phreesia.com.

Medical 52

Medical Patients 52

European Pharmaceutical Review

MARCH 10, 2023

Today marks the opening the NHS Blood and Transplant (NHSBT)’s new Clinical Biotechnology Centre (CBC) in Bristol. We won’t be designing the treatments but we will be manufacturing them to the right scale and clinical grade,” Dr Lilian Hook, NHSBT’s Director of Cell, Apheresis and Gene Therapies explained.

Manufacturing 127

Manufacturing Engineering Government Patients 127

pharmaphorum

AUGUST 3, 2022

The increases in Gilead’s oncology franchise comes as growth slows in its main HIV therapy business, and as sales of COVID-19 therapy Veklury (remdesivir) fell sharply as the pandemic starts to abate. Gilead’s HIV portfolio meanwhile brought in $4.2 billion, offsetting declines for older therapies.

Sales 91

Sales Management Marketing 91

European Pharmaceutical Review

JANUARY 10, 2023

The research recognised 15 late-stage experimental treatments forecast to deliver annual sales of over $1 billion within five years, including a wide range of therapeutic developments for rare diseases and difficult-to-treat conditions, including HIV, Parkinson’s, and cancer. Several Phase III trials are now underway.   .

Food and Drug Administration 90

Food and Drug Administration FDA Food Medicine 90

European Pharmaceutical Review

AUGUST 17, 2023

NIH’s vaccine candidate is based on the Adenovirus 4 backbone, largely used as a vector candidate in HIV and influenza vaccine clinical trials, produced in an A549 cell line. Intranasal vaccines have previously been used to immunise against conditions such as respiratory viruses, measles and rubella.

Manufacturing 89

Manufacturing Medicine Physicians Safety 89

Pharmacy Times

NOVEMBER 2, 2023

Paul Rainville, PharmD, CSP, AAHIVP, a clinical pharmacist and subject matter expert with Shields Health Solutions, discussed the current state of HIV in the United States

26

26

Pharmacy Times

NOVEMBER 20, 2023

In the second part of his interview with Pharmacy Times, PharmD, CSP, AAHIVP, a clinical pharmacist and subject matter expert with Shields Health Solutions, discussed pharmacists’ role in HIV education and management.

Education 26

Education Patients Management 26

Pharmaceutical Technology

JUNE 24, 2022

New vaccines and therapies for the prevention and treatment of malaria, tuberculosis, human immunodeficiency virus (HIV), neglected tropical diseases (NTDs) and anti-microbial resistance (AMR) will be the focus of this research. These ailments are said to account for over 60% of the disease burden in several lower-income countries.

Pharmaceutical 59

Pharmaceutical Medicine Healthcare Healthcare 59

Pharmacy Times

SEPTEMBER 13, 2023

Telemedicine approaches for HIV can help reduce stigma that is often a challenge in face-to-face clinical settings and eliminate common logistical barriers, such as transportation.

Transportation 26

Transportation 26

PharmaTech

AUGUST 3, 2023

They have developed a first-in-class, multipurpose intravaginal ring (IVR) that combines levonorgestrel with tenofovir to provide contraception while preventing against acquisition of Human Immunodeficiency Virus (HIV) and Herpes Simplex Virus (HSV).

Manufacturing 40

Manufacturing Specialization 40

Pharmacy Times

JULY 10, 2023

Despite an increase in HIV and poorer clinical outcomes among migrant populations, the uptake of PrEP among these individuals has been understudied.

26

26

European Pharmaceutical Review

SEPTEMBER 8, 2022

Comparing the use of common antiretroviral therapy (ART) regimens in pregnancy suggests that dolutegravir-based regimens have a higher probability of human immunodeficiency virus type 1 (HIV-1) viral suppression at delivery.

Medicine 99

Medicine Safety Physicians Pharmaceutical 99