Shots:
ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV
lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…
Shots:
The P-III (LATITUDE) trial assessed Cabenuva (cabotegravir + rilpivirine) in 453 adults facing adherence challenges, where 306 virally suppressed pts were randomized to Cabenuva (Q4W; n=152) or ART (QD, PO; n=154), with results published in The NEJM
At 48wks., Cabenuva reduced the cumulative risk of regimen failure (1EP) to 22.8% vs 41.2%, with fewer virologic failures…
Shots:
GSK & Shionogi, together with Pfizer, have agreed to replace Pfizer’s 11.7% economic interest in ViiV Healthcare with an investment by Shionogi, reshaping the ownership structure of ViiV Healthcare
As per the deal, ViiV Healthcare will issue new shares to Shionogi for $2.125B, cancel Pfizer’s stake, pay Pfizer $1.875B, & distribute a $0.25B special…
Shots:
ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) has received EC’s approval for Vocabria (cabotegravir) combined with J&J’s Rekambys (rilpivirine) to treat HIV-1 in virologically suppressed adolescents (≥12yrs. & ≥35kg), following CHMP opinion in Dec 2024
MAA was based on 24wks. data from ongoing P-I/II (MOCHA) trial evaluating the safety,…
Shots:
The EMA approved 9 New Chemical Entity (NCE) and 5 Biologic Drugs in July 2023, leading to treatments for patients and advances in the healthcare industry
In July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancer
PharmaShots has compiled a list…
Shots:
Dr. Harmony gave the details about the positive 12-month findings from the P-IIIb SOLAR trial of the first and only complete long-acting injectable regimen Cabenuva vs. Biktarvy
She also talked about the comparison of the Cabenuva regimen with the other existing & developing products for HIV including the Biktarvy regimen
The interview gives an…
Shots:
The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industry
In February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndrome
PharmaShots has compiled…
“Putting Ourselves to the Test: Achieving Equity to End HIV” -Theme of the year 2022
Introduction:
HIV/AIDS is one of the top 10 cause of mortality. It is a chronic, epidemic disease caused by human immunodeficiency virus (HIV), a virus that infect WBC’s CD4 T-cell of the immune system.
HIV, a type of retrovirus that isn't…
Shots:
Kimberly talked about the approval for label update of ViiV’s lead candidate in HIV, and how an optional oral lead-in will be efficient for people receiving it
Kimberly also spoke about ViiV’s collaboration with Janssen for the commercialization of the product
The interview gives an understanding of the different treatment options for HIV and…
In an interview with PharmaShots, Kimberly Smith, Senior Vice President, Head of Research & Development at ViiV Healthcare shared her views on the US FDA’s approval of the first long-acting injectable option of Apretude for the prevention of HIV
The approval is based on the P-IIb/III (HPTN 083/084) trial to evaluate cabotegravir (q8w) vs FTC/TDF (200/300 mg) in 7,700+ patients who…

